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Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality (Progressive)

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Progressive Relaxation Exercise
Sponsored by
Istanbul Sabahattin Zaim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer patients, Pain, Sleep quality, Progressive Relaxation Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Be between the ages of 18-65
  • Ability to communicate adequately
  • Absence of psychiatric problems
  • Those who are determined by the physician that they do not have a physical disability in exercising
  • Volunteering to participate in the research
  • Individuals who have the ability to use technological tools
  • Patients with at least 3 cures

Exclusion Criteria:

  • Individuals with phones that do not have voice recording capabilities
  • Individuals with phones that do not have the ability to install Whatsapp

Sites / Locations

  • Zülfünaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Progressive Relaxation Exercise

Control group

Arm Description

A total of 56 sessions of progressive relaxation were performed, 7 days a week for 8 weeks. Each session is set as fifty minutes

Routine maintenance will be applied

Outcomes

Primary Outcome Measures

Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Visual Analog Scale
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Modified Medical Research Council (mMRC)
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).
Modified Medical Research Council (mMRC)
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).
Modified Medical Research Council (mMRC)
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).

Secondary Outcome Measures

Full Information

First Posted
July 16, 2021
Last Updated
August 30, 2023
Sponsor
Istanbul Sabahattin Zaim University
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1. Study Identification

Unique Protocol Identification Number
NCT04978805
Brief Title
Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality
Acronym
Progressive
Official Title
The Effect of Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality in Lung Cancer Patients Receiving Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Sabahattin Zaim University

4. Oversight

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

5. Study Description

Brief Summary
This study was planned to examine the effect of progressive relaxation exercises applied to lung cancer patients receiving chemotherapy on dyspnea, pain and sleep quality.
Detailed Description
It is thought that relaxation exercises reduce respiratory distress and improve sleep quality in lung cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Cancer patients, Pain, Sleep quality, Progressive Relaxation Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is an experimental study with pre-test and post-test contro
Masking
Participant
Masking Description
Progressive Relaxation Exercise and control group
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Relaxation Exercise
Arm Type
Experimental
Arm Description
A total of 56 sessions of progressive relaxation were performed, 7 days a week for 8 weeks. Each session is set as fifty minutes
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Routine maintenance will be applied
Intervention Type
Behavioral
Intervention Name(s)
Progressive Relaxation Exercise
Intervention Description
In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Time Frame
1. week
Title
Visual Analog Scale
Description
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Time Frame
4. week
Title
Visual Analog Scale
Description
The patients were asked to mark their level of pain during relaxation or activities on a 10 cm vertical or horizontal line. In addition, there were forms which were numbered from 1-10 or from 1-100. The number 0 is found at the beginning of the line, and the number 10 is located at the end of the line. A value of 0 shows that there is no pain, and the value 10 expresses unendurable pain. GAS is a common scale in the assessment of pain level. A patient is asked to mark the perceived pain on this line, and the marked point is measured in cm
Time Frame
8. week
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Time Frame
1.week
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Time Frame
4.week
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI is a valid and consistent survey comprising of 19 questions to assess quality and amount of sleep and the existence of a sleep disorder and its level in the previous month. The scale was adapted into the Turkish language by Agargün et al. (1996). The scale consists of seven components that assess patients subjective sleep quality, sleep delay, use of sleeping medication and disfunction in daily activities. Each item scores in the range 0-3 points and the total score of the seven components gives the total PSQI score. The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep"
Time Frame
8.week
Title
Modified Medical Research Council (mMRC)
Description
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).
Time Frame
1.week
Title
Modified Medical Research Council (mMRC)
Description
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).
Time Frame
4.week
Title
Modified Medical Research Council (mMRC)
Description
It is a 5-item scale developed by English Medical Research Council to evaluate dyspnea. While applying Medical Research Council Dyspnea Scale, the patients are asked to indicate the level of activity that creates dyspnea in them. The patient chooses the most appropriate level that defines the respiratory problem by reading the options in the scale. The options are scored between 0 and 4; 0 means no dyspnea, 1 means mild dyspnea (respiratory distress when moving quickly and climbing slightly uphill); 2 means moderate dyspnea (walking slower than peers when walking straight on, stopping to breathe); 3 means severe dyspnea (stopping to breathe after walking about 100 m or for a few minutes) and 4 means very severe dyspnea (getting out of breath while doing daily chores at home, while putting on and taking off clothes and while going to toilet).
Time Frame
8.week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be between the ages of 18-65 Ability to communicate adequately Absence of psychiatric problems Those who are determined by the physician that they do not have a physical disability in exercising Volunteering to participate in the research Individuals who have the ability to use technological tools Patients with at least 3 cures Exclusion Criteria: Individuals with phones that do not have voice recording capabilities Individuals with phones that do not have the ability to install Whatsapp
Facility Information:
Facility Name
Zülfünaz
City
Istanbul
State/Province
State
ZIP/Postal Code
34303
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29281868
Citation
Borji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207.
Results Reference
background
PubMed Identifier
28069156
Citation
Tsitsi T, Charalambous A, Papastavrou E, Raftopoulos V. Effectiveness of a relaxation intervention (progressive muscle relaxation and guided imagery techniques) to reduce anxiety and improve mood of parents of hospitalized children with malignancies: A randomized controlled trial in Republic of Cyprus and Greece. Eur J Oncol Nurs. 2017 Feb;26:9-18. doi: 10.1016/j.ejon.2016.10.007. Epub 2016 Nov 18.
Results Reference
background

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Progressive Relaxation Exercise on Dyspnea, Pain and Sleep Quality

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