NCT05823350

Brief Summary

Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy. Methods: This randomized controlled study was conducted between October 2019 and December 2021 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. Thirty patients performing abdominal massage after colonoscopy were included in the experimental group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2.3 years

First QC Date

March 27, 2023

Last Update Submit

April 10, 2023

Conditions

Keywords

Abdominal massageColonoscopyAbdominal painPatients careAbdominal distension

Outcome Measures

Primary Outcomes (1)

  • Pain after colonoscopy

    Assesment of abdominal pain after colonoscopy by using numerical pain scale (0-10)

    Change from abdominal pain after the colonoscopy at 20 minutes after.

Secondary Outcomes (1)

  • Distension after colonoscopy

    Change from abdominal distension after the colonoscopy at 20 minutes after.

Study Arms (2)

Experimental group

EXPERIMENTAL

The relatives of the patients were shown the video before the colonoscopy. The video consisted of visual and verbal content about colonoscopy, and the benefits and application steps of abdominal massage in pain management after the procedure. After the procedure, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, when necessary, guidance was given to the patient's relatives about the application of the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques in the direction of the colon.

Other: Abdominal massage

Control Group

NO INTERVENTION

After the procedure, the patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications.

Interventions

Abdominal massage after colonoscopy

Experimental group

Eligibility Criteria

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

You may qualify if:

  • Undergoing an elective total colonoscopy
  • Having an attendant before and after the procedure
  • ASA score ≤ 2
  • Accepting the application of abdominal massage

You may not qualify if:

  • Not knowing Turkish himself/herself or his/her attendant
  • Having a problem that prevents the application of abdominal massage (past abdominal surgery, irritable bowel disease, bowel cancer diagnosis, gastrointestinal or urinary ostomy, etc.)
  • Not wanting to have an abdominal massage
  • Failure of the attendant to learn abdominal massage
  • Inability to perform colonoscopy completely due to insufficient bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Abdominal PainDilatation, Pathologic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental - Randomised Controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 21, 2023

Study Start

September 15, 2019

Primary Completion

December 15, 2021

Study Completion

September 15, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available.

Locations