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Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery

Primary Purpose

Postoperative Pain, Nursing Caries, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Relaxation Exercise
Sponsored by
YASEMİN ÖZHANLI
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Progressive relaxation exercise, Colorectal cancer surgery, Pain, Anxiety, Nursing care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being 18 years or over,
  • Consenting to participate in the study with verbal and written declaration after being informed,
  • Being scheduled for elective laparoscopic colorectal cancer surgery,
  • Not participating in another randomized controlled study simultaneously.

Exclusion Criteria:

  • Having a health problem that will alter cortisol release,
  • Preoperative and postoperative unconsciousness,
  • Having a psychiatric problem,
  • Having a disease that requires corticosteroid therapy,
  • Developing any complications during the operation.

Sites / Locations

  • Istanbul University-Istanbul Medical Faculty Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Progressive Relaxation Exercise

Standard Care

Arm Description

In individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3.

In the control group, no application made during and after the surgical intervention, and routine treatment and care applied.

Outcomes

Primary Outcome Measures

Preoperative pain severity
Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative anxiety severity
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative pulse rate (heart rate per minute) (1st. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative body temperature (Celcius) (1st. assessment)
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative oxygen saturation (SpO2) (1st. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative serum cortisol levels (1st. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am). For the control group The first evaluation was made 6.45am.
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative body temperature (Celcius) (2nd. assessment)
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative oxygen saturation (SpO2) (2nd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative serum cortisol levels (2nd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
Use of analgesic (See Table 1)(postoperative 1st. day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
Use of analgesic (See Table 1)(postoperative 2nd day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Use of analgesic (See Table 1)(postoperative 3rd day)
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other

Secondary Outcome Measures

Postoperative pain severity
Pain severity assessment with Short Form McGill Pain Questionnaire For the experimental group The pain assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am). For the control group Postoperative pain assessment of the control group was made on the 3rd day after surgery. Postoperative pain assessment of the control group was made on the 3rd day after surgery. Post-operative pain assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Postoperative anxiety severity
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group The anxiety assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am). Anxiety assessment for the control group Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Post-operative anxiety assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative pulse rate (heart rate per minute) (1st. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative pulse rate (heart rate per minute) (2nd. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative pulse rate (heart rate per minute) (3rd. assessment)
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative respiratory rate (respiratory per minute) (1st. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative body temperature (celcius) (1st. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative body temperature (celcius) (2nd. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative body temperature (celcius) (3rd. assessment)
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative oxygen saturation (SpO2) (1st. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative oxygen saturation (SpO2) (2nd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative oxygen saturation (SpO2) (3rd. assessment)
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Postoperative serum cortisol levels (1st. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The first day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Postoperative serum cortisol levels (2nd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The second day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The second day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Postoperative serum cortisol levels (3rd. assessment)
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The third day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The third day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.

Full Information

First Posted
January 15, 2021
Last Updated
January 28, 2021
Sponsor
YASEMİN ÖZHANLI
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1. Study Identification

Unique Protocol Identification Number
NCT04731428
Brief Title
Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery
Official Title
The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
June 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YASEMİN ÖZHANLI

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. This research data was collected between March 2018 and May 2019. The research was carried out with 63 patients (experiment group= 31, control group= 32) who underwent elective laparoscopic colorectal surgery in a general surgery clinic of a university hospital in Istanbul and in accordance with the research criteria. Patients in the experiment group were taught breathing exercises in the preoperative period and on the 1st, 2nd and 3rd day after surgery then, progressive relaxation exercise that lasted 15 minutes was applied to the group. Pain (Short McGill Pain Scale) and anxiety (STAI-S Scale) levels of both groups were evaluated in the preoperative and postoperative period. The patient's vital signs, oxygen saturation and serum cortisol level parameters were measured in the same time interval before and after the relaxation exercise. Significance was evaluated at p <0.05 and p<0,001 levels in the analysis of the data. Prior to the study, the consent of the institution and ethics committee, written and verbal patient consent were obtained.
Detailed Description
The universe of the study consisted of patients with colorectal cancer who were admitted to Istanbul University, Istanbul Faculty of Medicine, General Surgery Clinics for treatment between March 2018 and May 2019 and who would undergo laparoscopic surgery.The research was planned as a randomized controlled experimental study. Block randomization method was to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program(https://www.randomizer.org/) was used. Randomization done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list.Research data will be collected in a hospital's general surgery ward between March 2018 and May 2019. The independent variable of the study is Progressive Relaxation Exercise.The dependent variables of the study are physiological parameters, pain, anxiety and serum cortisol. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nursing Caries, Anxiety
Keywords
Progressive relaxation exercise, Colorectal cancer surgery, Pain, Anxiety, Nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Relaxation Exercise
Arm Type
Experimental
Arm Description
In individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
In the control group, no application made during and after the surgical intervention, and routine treatment and care applied.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Relaxation Exercise
Intervention Description
Progressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group.
Primary Outcome Measure Information:
Title
Preoperative pain severity
Description
Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Time Frame
Preoperative pain assessment of the groups was made 2 hours before surgery.
Title
Preoperative anxiety severity
Description
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Time Frame
Preoperative anxiety assessment of the groups was made 2 hours before surgery.
Title
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Description
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am). For the control group The first evaluation was made 6.30am.
Time Frame
In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
Title
Preoperative pulse rate (heart rate per minute) (1st. assessment)
Description
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am). For the control group The first evaluation was made 6.30am.
Time Frame
In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
Title
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Time Frame
In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
Title
Preoperative body temperature (Celcius) (1st. assessment)
Description
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Time Frame
In the preoperative period, body temperature was evaluated 2 hours before surgery
Title
Preoperative oxygen saturation (SpO2) (1st. assessment)
Description
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Time Frame
In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
Title
Preoperative serum cortisol levels (1st. assessment)
Description
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am). For the control group The first evaluation was made 6.45am.
Time Frame
In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
Title
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
Description
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Time Frame
Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
Title
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Description
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Time Frame
In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
Title
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Time Frame
In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
Title
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Time Frame
In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
Title
Preoperative body temperature (Celcius) (2nd. assessment)
Description
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Time Frame
In the preoperative period, body temperature was evaluated 1 hour before surgery.
Title
Preoperative oxygen saturation (SpO2) (2nd. assessment)
Description
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Time Frame
In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
Title
Preoperative serum cortisol levels (2nd. assessment)
Description
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
Time Frame
In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
Title
Use of analgesic (See Table 1)(postoperative 1st. day)
Description
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
Time Frame
Analgesic consumption of the patients was recorded in the postoperative 1st. day.
Title
Use of analgesic (See Table 1)(postoperative 2nd day)
Description
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Time Frame
Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
Title
Use of analgesic (See Table 1)(postoperative 3rd day)
Description
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other
Time Frame
Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
Secondary Outcome Measure Information:
Title
Postoperative pain severity
Description
Pain severity assessment with Short Form McGill Pain Questionnaire For the experimental group The pain assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am). For the control group Postoperative pain assessment of the control group was made on the 3rd day after surgery. Postoperative pain assessment of the control group was made on the 3rd day after surgery. Post-operative pain assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Time Frame
Postoperative pain assessment of the groups was made postoperative 3rd. day.
Title
Postoperative anxiety severity
Description
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group The anxiety assessment of the experimental group in the postoperative period was made on the 3rd day after surgery. This evaluation was made 1 hour after the progressive relaxation exercise on the 3rd postoperative day (8.30 am). Anxiety assessment for the control group Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Postoperative anxiety assessment of the control group was made on the 3rd day after surgery. Post-operative anxiety assessment of the control group was performed at the same time (8.30 am) to ensure intergroup equivalence.
Time Frame
Postoperative anxiety assessment of the groups was made postoperative 3rd. day.
Title
Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
Description
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.
Title
Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
Description
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.
Title
Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
Description
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.
Title
Postoperative pulse rate (heart rate per minute) (1st. assessment)
Description
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.
Title
Postoperative pulse rate (heart rate per minute) (2nd. assessment)
Description
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.
Title
Postoperative pulse rate (heart rate per minute) (3rd. assessment)
Description
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.
Title
Postoperative respiratory rate (respiratory per minute) (1st. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.
Title
Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.
Title
Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
Description
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.
Title
Postoperative body temperature (celcius) (1st. assessment)
Description
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Body temperature (0C) evaluation was made on postoperative 1st. day.
Title
Postoperative body temperature (celcius) (2nd. assessment)
Description
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Body temperature (0C) evaluation was made on postoperative 2nd. day.
Title
Postoperative body temperature (celcius) (3rd. assessment)
Description
Body temperature (celcius)assessment was made with a digital thermometer. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Body temperature (0C) evaluation was made on postoperative 3rd. day.
Title
Postoperative oxygen saturation (SpO2) (1st. assessment)
Description
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
Title
Postoperative oxygen saturation (SpO2) (2nd. assessment)
Description
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
Title
Postoperative oxygen saturation (SpO2) (3rd. assessment)
Description
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Measurements were made before and after progressive relaxation exercise. For the control group The measurements of the control group were made at the same time as the measurements of the experimental group to ensure intergroup equivalence.
Time Frame
Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
Title
Postoperative serum cortisol levels (1st. assessment)
Description
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The first day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Time Frame
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.
Title
Postoperative serum cortisol levels (2nd. assessment)
Description
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The second day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The second day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Time Frame
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.
Title
Postoperative serum cortisol levels (3rd. assessment)
Description
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The third day evaluation was made 45 minutes after applying the progressive relaxation exercise (8.00 am). For the control group The third day evaluation was made 8.00 am. Progressive relaxation exercise wasn't applied because of was control group.
Time Frame
In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Being 18 years or over, Consenting to participate in the study with verbal and written declaration after being informed, Being scheduled for elective laparoscopic colorectal cancer surgery, Not participating in another randomized controlled study simultaneously. Exclusion Criteria: Having a health problem that will alter cortisol release, Preoperative and postoperative unconsciousness, Having a psychiatric problem, Having a disease that requires corticosteroid therapy, Developing any complications during the operation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuray Akyüz, Assoc. Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yasemin Özhanlı, PhD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Chair
Facility Information:
Facility Name
Istanbul University-Istanbul Medical Faculty Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34903440
Citation
Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.
Results Reference
derived

Learn more about this trial

Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery

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