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

Sponsor

Ataturk University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05969509

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

26.5

Patients Per Site Per Month

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Other: progressive relaxation exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two groups consisting of experimental and control groups performed cholecystectomy.two groups consisting of experimental and control groups performed cholecystectomy.

Masking:

Single (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

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the group that performed relaxation exercises patients' postoperative pain and bowel movements will be evaluated by applying relaxation exercise intermittently	Other: progressive relaxation exercise applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups
No Intervention: the group that did not do relaxation exercises patients' postoperative pain and bowel movements will be evaluated

Arm

Intervention/Treatment

Experimental: the group that performed relaxation exercises

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

Other: progressive relaxation exercise

applying progressive relaxation exercise to the experimental group after postoperative cholecystectomy and observing the experimental-control groups

No Intervention: the group that did not do relaxation exercises

patients' postoperative pain and bowel movements will be evaluated

Outcome Measures

Primary Outcome Measures

Visual Analog Scale (VAS) Pain Form [examination between 1-2 days until Decontamination from surgery]
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 [examination between 1-2 days until Decontamination from surgery]
It is the form in which the intestinal sounds, gas extraction and defecation sounds of the patients are monitored by the researcher.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Van Yüzüncü Yıl University Dursun Odabaş Medical Center	VAN		Turkey	65000

Sponsors and Collaborators

Ataturk University

Investigators

Principal Investigator: şuheda zorer, van yüzüncü yıl university dursun odabaş medical center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Şuheda Zorer, principal investigator, Ataturk University

ClinicalTrials.gov Identifier:

NCT05969509

Other Study ID Numbers:

AtaturkU-SBF-SZ-01

First Posted:

Aug 1, 2023

Last Update Posted:

Aug 1, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Aug 1, 2023