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The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy

Primary Purpose

Cholecystectomy, Nursing Caries, Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Heat Therapy
Sponsored by
T.C. ORDU ÜNİVERSİTESİ
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cholecystectomy focused on measuring hot application, postoperative pain, nursing care, laparoscopic cholecystectomy

Eligibility Criteria

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

Inclusion Criteria:

  • who agreed to participate in the research
  • 18 years old and over
  • BMI within normal limits
  • VAS score of 5 or higher

Exclusion Criteria:

  • who refused to participate in the research
  • with a history of upper laparotomy
  • Having endocrine, renal, hepatic or immunological disease
  • ASA (American Society of Anesthesiologists) score above 3
  • with chronic shoulder pain
  • Regular use of analgesics
  • using sedative drugs

Sites / Locations

  • Ordu ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heat Therapy Group

Control group

Arm Description

The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged.

When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.

Outcomes

Primary Outcome Measures

Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
pain Score
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain

Secondary Outcome Measures

Full Information

First Posted
November 26, 2021
Last Updated
November 26, 2021
Sponsor
T.C. ORDU ÜNİVERSİTESİ
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1. Study Identification

Unique Protocol Identification Number
NCT05149612
Brief Title
The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy
Official Title
The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy: A Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
T.C. ORDU ÜNİVERSİTESİ

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 determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters (blood pressure, pulse, respiratory rate, pain score, oxygen saturation. The hypothesis of the study: To see the effect of hot application and its effect on physiological parameters after hot application in individuals who have undergone laparoscopic cholecystectomy. The population of the study will consist of patients who were admitted to the OMU SUVAM General Surgery Service and underwent laparoscopic cholecystectomy. The sample of the study will consist of individuals who have undergone 84 laparoscopic cholecystectomy operations, who agreed to participate in the study, and who met the criteria for inclusion in the study, between the specified dates. The sample size of the study was determined in the G*Power 3.1.9.4 program by considering Cohen's standard effect sizes. Effect size was calculated based on 0.25, Type I error 0.05, Type II error 0.20 (80% power) and 38 patients were calculated for each group, but considering data loss, it was aimed to reach 10% more, with 42 patients for each group and 84 patients in total. Which group the individuals in the sample group would be in was determined by randomization, and a randomization table was created over two groups. In the study, data will be collected using the Patient Information Form, Visual Analogue Scale (VAS) and Physiological Parameter Form. The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged. When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.
Detailed Description
In the management of shoulder pain experienced by individuals after laparoscopic cholecystectomy, pharmacological methods such as nonsteroidal anti-inflammatory drugs (NSAID), gabapentinoids, local analgesics, cyclooxygenase-2 (COX-2) inhibitors, transversus abdominis plane (TAP) block and opioids (Eftekhariyazdi et al. 2020; Gurusamy et al. 2014; Salazar-Perra et al. 2020) and peripheral techniques, cognitive behavioral techniques, and non-pharmacological methods other than these can be applied in order to increase the effectiveness of pharmacological methods or to increase the effectiveness of pharmacological methods (İbrahim and Ali 2020; Komann et al. et al. 2020; Pak et al. 2016; Tick et al. 2018; Şimsek Wild 2019). One of the techniques commonly used to reduce or relieve pain among peripheral techniques is hot application. Hot application activates the gate control mechanism, stimulates tactile receptors, removes metabolic wastes, increases the release of endorphins, reduces muscle spasms as a result of the change in viscoelastic properties in tissues, reduces pressure, tension and hypoxia in nerve endings, raises the pain threshold, provides sedation and relaxes the individual. it reduces or relieves pain (Ibrahim and Ali 2020; Perry et al. 2017). In order to benefit from the therapeutic effect of hot application, the application time should not exceed 30 minutes. If the application period lasts more than 35-40 minutes, congestion occurs in the tissue, and in hot applications lasting more than one hour, vasoconstriction may occur instead of vasodilation, and the opposite of the desired effect may occur. In hot application, the temperature is as important as the time. Although there is no evidence-based guideline for hot applications, the temperature should be 40-45ºC. It is recommended that hot application at these temperatures has a therapeutic effect by giving heat to the skin (Ibrahim and Ali 2020; Türkmen 2017). In addition, it has an important place in nursing practices as one of the preferred nursing interventions in the non-pharmacological treatment of pain due to its ease of use, high level of patient satisfaction and rare side effects (Mohamed 2016; Perry et al. 2017). Although there are studies in the literature in which different non-pharmacological nursing interventions have been applied to manage the shoulder pain experienced by individuals after cholecystectomy, no study has been found in which warm application has been made. Therefore, this study was planned to examine the effect of hot application applied to patients who underwent laparoscopic cholecystectomy on shoulder pain and physiological parameters. This study was planned to determine the effect of hot application applied to patients undergoing laparoscopic cholecystectomy on shoulder pain and physiological parameters. The hypotheses of the study: H01: Warm application applied after laparoscopic cholecystectomy is not effective in reducing shoulder pain experienced by individuals. H11: Warm application applied after laparoscopic cholecystectomy reduces the shoulder pain experienced by individuals. H02: Warm application applied after laparoscopic cholecystectomy is not effective in maintaining the physiological parameters of individuals within normal limits. H12: Warm application applied after laparoscopic cholecystectomy ensures that the physiological parameters of the patients are maintained within normal limits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Nursing Caries, Shoulder Pain
Keywords
hot application, postoperative pain, nursing care, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The individuals in the sample group will be divided into two groups as the hot application group and the control group. Individuals in the control group will not be treated with heat.
Masking
ParticipantOutcomes Assessor
Masking Description
Patients will not be told which group they are in. In order to avoid bias in the data collection phase, support will be received from the nurses working in the general surgery service independently of the research, and from the independent statistical expert, apart from the researcher, in the database of the research.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heat Therapy Group
Arm Type
Experimental
Arm Description
The patients in the intervention group will be treated with hot water bags twice, for 20 minutes in the morning and 20 minutes in the evening, to the shoulder area, starting four hours after the operation, until the patient is discharged.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
When the individuals in the control group have pain, analgesic drug treatment will be applied at the request of the physician, and no other intervention will be applied.
Intervention Type
Other
Intervention Name(s)
Heat Therapy
Intervention Description
Patients in the intervention group will be treated with hot water bags twice, 20 minutes in the morning and 20 minutes in the evening, starting four hours after the operation until discharge. In accordance with the literature, the water bag filled with 55 ± 2°C hot water will be wrapped with 2 towels. The water bag will be applied to the shoulder area while the patient is in the fawler or semi-fawler position. After 20 minutes, the hot application will be terminated. Pain and physiological parameters of the patients will be evaluated at the 0th minute, 30th minute, 4th hour, 12th hour, 24th hour and 48th hour postoperatively. At the same time, when individuals have pain, analgesics will be administered at the request of the physician.
Primary Outcome Measure Information:
Title
Pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 0th minute right after the patients come from the operation
Title
Pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 30th minute after the patients come from the operation
Title
Pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 4th hour after the patients come from the operation,
Title
Pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 12th hour after the patients come from the operation
Title
Pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 24th hour after the patients come from the operation
Title
pain Score
Description
The primary outcome of the study was to measure pain using a 10-cm VAS, with high numbers meaning greater pain intensity. The VAS is used to measure various subjective clinical phenomena, including pain. It is quick and easy to use and score. The 0-10 VAS requires the patients to choose a number from 0 to 10 that best represents their pain; 0 is the equivalent of "no pain," and 10 is the equivalent of the worst imaginable pain
Time Frame
At the 48th hour after the patients come from the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who agreed to participate in the research 18 years old and over BMI within normal limits VAS score of 5 or higher Exclusion Criteria: who refused to participate in the research with a history of upper laparotomy Having endocrine, renal, hepatic or immunological disease ASA (American Society of Anesthesiologists) score above 3 with chronic shoulder pain Regular use of analgesics using sedative drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feyza Bayraktar, bachelor's
Phone
5530941996
Ext
+90
Email
fyzbyrktr@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanife Durgun, PhD
Organizational Affiliation
T.C. ORDU ÜNİVERSİTESİ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ordu Üniversitesi
City
Ordu
State/Province
Altınordu
ZIP/Postal Code
52200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanife Durgun, PhD
Phone
5549954010
Ext
+90
Email
hanife.balik@gmail.com

12. IPD Sharing Statement

Learn more about this trial

The Effect of Heat Therapy on Shoulder Pain and Physiologic Parameters After Laparoscopic Cholecystectomy

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