NCT05969509

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

July 12, 2023

Last Update Submit

April 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    examination between 1-2 days until Decontamination from surgery

  • 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.

    examination between 1-2 days until Decontamination from surgery

Study Arms (2)

the group that performed relaxation exercises

EXPERIMENTAL

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

Other: progressive relaxation exercise

the group that did not do relaxation exercises

NO INTERVENTION

patients' postoperative pain and bowel movements will be evaluated

Interventions

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

the group that performed relaxation exercises

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Who experienced laparoscopic cholecystectomy surgery as planned for the first time
  • Who volunteered to participate in the research
  • years and over
  • Whose mental state is healthy
  • Without vision, hearing and speech problems
  • Patients who know Turkish were included in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van Yüzüncü Yıl University Dursun Odabaş Medical Center

Van, 65000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Zorer Yilmaz S, Gurcayir D. The Effect of Progressive Relaxation Exercises on Pain and Bowel Movements in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial. Asian Nurs Res (Korean Soc Nurs Sci). 2025 Oct;19(4):410-416. doi: 10.1016/j.anr.2025.08.004. Epub 2025 Sep 18.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • şuheda zorer

    van yüzüncü yıl university dursun odabaş medical center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: two groups consisting of experimental and control groups performed cholecystectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 12, 2023

First Posted

August 1, 2023

Study Start

December 1, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations