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The Effect of Abdominal Massage on Pain and Distention After Colonoscopy

Primary Purpose

Colonoscopy, Pain, Abdominal, Massage

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal massage
Sponsored by
Trakya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colonoscopy focused on measuring Abdominal massage, Colonoscopy, Abdominal pain, Patients care, Abdominal distension

Eligibility Criteria

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

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

Sites / Locations

  • Trakya University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distension after colonoscopy
Assesment of abdominal distension after colonoscopy by using numerical comparison scale (0-10)

Full Information

First Posted
March 27, 2023
Last Updated
April 10, 2023
Sponsor
Trakya University
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1. Study Identification

Unique Protocol Identification Number
NCT05823350
Brief Title
The Effect of Abdominal Massage on Pain and Distention After Colonoscopy
Official Title
The Effect of Abdominal Massage on Pain and Distention in Patients Underwent Colonoscopy - A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
September 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya 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
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.
Detailed Description
Aim: This study aimed to evaluate the effect of abdominal massage on pain and distention in patients who underwent colonoscopy. Methods: Settings and Design This randomized controlled experimental study was conducted between September 2019 and September 2022 with the participation of 60 patients who underwent colonoscopy in the endoscopy unit of a university hospital. The patients who underwent elective total colonoscopy, were accompanied by an attendant before and after the procedure, had an ASA score of ≤ 2, had no problem that would prevent the application of abdominal massage (past abdominal surgery, irritable bowel disease, diagnosis of bowel cancer, gastrointestinal or urinary ostomy, etc.), and accepted the application of abdominal massage after the procedure, were included in the study. Patients who did not speak Turkish or didn't have any attendant who could speak Turkish, who did not want to receive abdominal massage, who couldn't learn abdominal massage or did not want to do it, and the patients for whom the procedure was not fully implemented due to reasons such as insufficient bowel preparation, were excluded from the study. During the study's follow-up period, no complications related to colonoscopy were observed in the participating patients. Data Collection Tools Patient information form and patient follow-up form were used for collecting research data. The patient information form included 3 questions investigating the sociodemographic characteristics of the patients (age, gender, experience of colonoscopy). The patient follow-up form contains four questions including the patients' pain and distension level after colonoscopy and abdominal massage. The level of pain and distension was evaluated with a 0-10 numerical comparison scale (Dreyer ve ark. 2015). Data Collection The number of patients in each group was determined to be equal (30:30) by randomization carried out through the computer program called Research Randomiser. The group that received abdominal massage was accepted as the experimental group. On the day of the procedure, all patients who came to the endoscopy unit for a total colonoscopy were informed by the researcher about the study and then written and verbal informed consents were obtained from the patients. In the control group, after the procedure, one relative was allowed to accompany each patient who was taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. The vital signs of the patients who received standard care were monitored after the procedure and were followed up for possible complications. The pain and distension levels of the patients were evaluated again 20 minutes after the first assessment (second evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular access catheter was removed. In the experimental group, the relatives of the patients were shown the video in the preparation room before the colonoscopy. The video consisted of visual and verbal content about the definition, purposes, application, and importance of the colonoscopy, the purpose of insufflation, pain management during and after the procedure, and the benefits and application steps of abdominal massage in pain management after the procedure. The video lasted 3 minutes and 19 seconds. After the procedure, a relative was allowed to accompany each of the experimental group patients who were taken to the care room after the endoscopy. The patients who were taken to their beds were asked to evaluate their pain and distension levels after the colonoscopy (first evaluation). The initial pain and distension levels after the procedure were recorded on the form by the researcher. Afterwards, the relatives of the patients in the experimental group were asked to apply abdominal massage to their patients. During the massage application, the patient and their relatives were observed by the researcher, and when necessary, guidance was given to the patient's relatives about the application of the massage. Liquid vaseline was used to ensure the slipperiness of the hands during the massage. In this supine position, patient's abdomen was massaged with circular movements and different techniques (kneading, vibration, efflorescence, superficial or deep strokes) in the direction of the colon. As suggested in the literature, an abdominal massage lasted 15 minutes (Yıldırım et al. 2019). When necessary, verbal and visual guidance was provided by the researcher to ensure that the massage was performed with the correct steps and for the required time.After 5 minutes after the massage application, the researcher evaluated the patients' pain and distension levels and recorded the data on the form (second evaluation; 20 minutes after the first evaluation). After the procedure, patients who met the discharge criteria were given discharge training and they were allowed to leave the endoscopy unit after the vascular catheter was removed. Statistical Analysis Data obtained from sixty-five patients were analyzed using the IBM SPSS 22.0 (IBM, Armonk, New York, USA) package program. Normal distribution was determined by the Kolmogorov-Smirnov test. The Mann-Whitney U test was used to compare the pain and distention scores between the two groups. Wilcoxon Signed rank test was used to compare the means of pain and distention scores within the group. The statistical significance level was accepted as p < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy, Pain, Abdominal, Massage, Distension; Bowel, Patients Care, Nursing
Keywords
Abdominal massage, Colonoscopy, Abdominal pain, Patients care, Abdominal distension

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental - Randomised Controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Abdominal massage
Intervention Description
Abdominal massage after colonoscopy
Primary Outcome Measure Information:
Title
Pain after colonoscopy
Description
Assesment of abdominal pain after colonoscopy by using numerical pain scale (0-10)
Time Frame
Change from abdominal pain after the colonoscopy at 20 minutes after.
Secondary Outcome Measure Information:
Title
Distension after colonoscopy
Description
Assesment of abdominal distension after colonoscopy by using numerical comparison scale (0-10)
Time Frame
Change from abdominal distension after the colonoscopy at 20 minutes after.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing an elective total colonoscopy Having an attendant before and after the procedure ASA score ≤ 2 Accepting the application of abdominal massage Exclusion Criteria: 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
Facility Information:
Facility Name
Trakya University
City
Edirne
ZIP/Postal Code
22030
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IPD available.

Learn more about this trial

The Effect of Abdominal Massage on Pain and Distention After Colonoscopy

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