The Effect of Progressive Muscle Relaxation on Abdominal Pain and Distension in Colonoscopy Patients.

June 15, 2021 updated by: Seher Tanrıverdi, Mardin Artuklu University
Patients undergoing colonoscopy were divided into progressive relaxation exercises and control groups. Pretest and posttest abdominal pain and distention scores of the patients were determined after colonoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mardin, Turkey, 47000
        • Mardin State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing colonoscopy
  • Those who do not have communication problems,
  • After the colonoscopy procedure, the abdominal pain score is evaluated by VAS and is 4 or higher,
  • Evaluation of the distension score of 4 and above with VAS after the colonoscopy procedure,
  • Be 18 years old or older.

Exclusion Criteria:

  • Being a hospitalized patient undergoing colonoscopy,
  • Be younger than 18 years old
  • To have used complementary and alternative methods during the research,
  • Any physical problem that may prevent you from doing the exercises,
  • Having a cognitive illness
  • Refusing to participate in the research,
  • Failing to complete surveys.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
The experimental group was informed about progressive muscle relaxation (PMR) before colonoscopy. PMR audio recordings were given to the patients. Abdominal pain and distention scores were determined after colonoscopy. PMR was applied to the patients for 30 minutes. These scores were determined again after exercise and at the 2nd, 4th, 8th, 12th, 16th, and 24th hours.
Behavioral: Progressive Muscle Relaxation
PMR is a technique that provides relaxation in the whole body by voluntary and regular relaxation of large muscle groups in the human body, which is included in mind-body applications.
No Intervention: Control Group
VAS pain and VAS distension scores of the control group were determined after colonoscopy and 30 minutes later. VAS form was given to all patients to determine VAS abdominal pain and VAS distension scores at the 2nd, 4th, 8th, 12th, 16th and 24th hours after the procedure. The day after the colonoscopy, post test data were collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individual Introductory Information Form
Time Frame: 15 minutes
This form, which was created by the researcher with the support of the relevant literature, consists of 11 questions questioning the patients' education level, age,gender, employment status, marital status,income level, the coping methods they use when there is distension in their daily lives, the coping methods they use when there is pain in their daily lives, the status of having a colonoscopy before, the history of abdominal pain and distension of those who have a colonoscopy experience.
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 10 minutes
The patient was asked to make a mark on a 10 cm horizontal line on the Visual analog scale showing his current state. In this study, for pain and distension; Markings were made on a 10 cm horizontal line, one end of which indicates that the patient's pain is very good (0 = no pain) and the other end is that the patient's pain is very bad (10 = most severe). The distance from the point where there was no pain and distension (0) to the point marked by the patient was measured. The value found shows the severity of pain and distention of the patient.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mardin Artuklu University

Investigators

  • Principal Investigator: Seher Tanrıverdi, Mardin Artuklu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mardin Artuklu University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

can be reviewed by other researchers after the study has been published.

IPD Sharing Time Frame

data will be shared as long as they are published

IPD Sharing Access Criteria

publication page

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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