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Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
progressive relaxation exercise
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative

Eligibility Criteria

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

Inclusion Criteria: Who experienced laparoscopic cholecystectomy surgery as planned for the first time Who volunteered to participate in the research 18 years and over Whose mental state is healthy Without vision, hearing and speech problems Patients who know Turkish were included in the study. Exclusion Criteria: Who have previously practiced progressive relaxation exercises Someone with communication problems Health problems that prevent the practice of progressive relaxation exercises (Epilepsy, bipolar disorder, schizophrenia, fever, infection, etc. ) is Patients who were not willing to participate in the study were not included in the study.

Sites / Locations

  • Van Yüzüncü Yıl University Dursun Odabaş Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the group that performed relaxation exercises

the group that did not do relaxation exercises

Arm Description

patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently

patients' postoperative pain and bowel movements will be evaluated

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) Pain Form
it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line
bowel movement monitoring form
It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2023
Last Updated
July 23, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05969509
Brief Title
Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy
Official Title
Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk 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
The goal of this clinical trial is to compare in health conditions. The main questions it aims to answer are: Does progressive relaxation exercises reduce pain in patients undergoing laparoscopic cholecystectomy? Does progressive relaxation exercises increase bowel movements in patients undergoing laparoscopic cholecystectomy?
Detailed Description
The purpose of our experimentally randomized controlled study, which researchers conducted in order to study the effect of progressive relaxation exercises on pain and bowel movements in patients undergoing laparoscopic cholecystectomy, is to reduce pain by intermittent application of progressive relaxation exercises to patients after surgery and to study the effect of exercise on bowel movements at an early stage. after the necessary permissions have been obtained july- september dates, Van Yüzüncü yıl university Dursun Odabaş medical center, in the general surgery clinic , patients who agree to participate in the study and meet the sample selection criteria will be included in the study. Patient presentation form, bowel movement monitoring form and Visual Analog Scale (VAS) Pain Form will be used in the collection of research data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two groups consisting of experimental and control groups performed cholecystectomy.
Masking
Outcomes Assessor
Masking Description
the cholecystectomy group will be given exercise sessions and the result evaluations will be performed by a researcher who is blind to the group allocation
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the group that performed relaxation exercises
Arm Type
Experimental
Arm Description
patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently
Arm Title
the group that did not do relaxation exercises
Arm Type
No Intervention
Arm Description
patients' postoperative pain and bowel movements will be evaluated
Intervention Type
Other
Intervention Name(s)
progressive relaxation exercise
Intervention Description
applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Pain Form
Description
it is a scale with two ends named differently on the vertical or horizontal line with a length of 10 cm (0=no pain, 10=the most severe pain). Marking the point corresponding to the intensity of pain felt by the patient on this line
Time Frame
examination between 1-2 days until Decontamination from surgery
Title
bowel movement monitoring form
Description
It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.
Time Frame
examination between 1-2 days until Decontamination from surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Who experienced laparoscopic cholecystectomy surgery as planned for the first time Who volunteered to participate in the research 18 years and over Whose mental state is healthy Without vision, hearing and speech problems Patients who know Turkish were included in the study. Exclusion Criteria: Who have previously practiced progressive relaxation exercises Someone with communication problems Health problems that prevent the practice of progressive relaxation exercises (Epilepsy, bipolar disorder, schizophrenia, fever, infection, etc. ) is Patients who were not willing to participate in the study were not included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
şuheda zorer
Phone
05427336700
Email
zorersuheda@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
şuheda zorer
Organizational Affiliation
van yüzüncü yıl university dursun odabaş medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Van Yüzüncü Yıl University Dursun Odabaş Medical Center
City
VAN
ZIP/Postal Code
65000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Van Yüzüncü Yıl Üniversitesi Dursun Odabaş Tıp Merkezi
Phone
(0432) 215 04 70
Email
hastane@yyu.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy

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