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The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction

Primary Purpose

Healthy

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Abdominal Massage
Sponsored by
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy focused on measuring Colonoscopy, abdominal massage, abdominal pain, abdominal distension, abdominal discomfort, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • being of 18 years of age and above
  • owning a cell phone
  • having a body mass index below 30
  • being conscious and having location
  • people, and time orientation
  • having no communication barriers
  • being able to communicate in Turkish
  • giving written informed consent to participate in the study

Exclusion Criteria:

  • were receiving sedation
  • having previously received intestine resection or other intestinal surgery
  • having an uncontrolled psychopathological illness
  • receiving colonoscopy for treatment
  • having active lower gastrointestinal system bleeding

Sites / Locations

  • Prof. Dr. Cemil Taşcıoğlu City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Abdominal Massage Group

Placebo Group

Arm Description

Abdominal massage for 15 minutes twice a day application.

Abdominal massage was not applied.

Outcomes

Primary Outcome Measures

Abdominal pain
Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value

Secondary Outcome Measures

Abdominal distension
Abdominal distension will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value

Full Information

First Posted
July 10, 2021
Last Updated
July 30, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
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1. Study Identification

Unique Protocol Identification Number
NCT04979351
Brief Title
The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction
Official Title
The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction: A Randomized Controlled Study Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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
Background: Abdominal pain, distension, and discomfort are the most frequently seen side effects after colonoscopy. These side effects can cause physical and mental results and increased workloads and care costs. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. Currently, there are no studies evaluating the effects of abdominal massage on post colonoscopy these abdominal symptoms. The aim of this study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction. Methods: This study was designed as a prospective randomized controlled study. Participants meeting inclusion criteria will be assigned to intervention and control groups using a random number generator. Participants assigned to the intervention group will receive abdominal massages twice a day after colonoscopy, and participants assigned to the control group will receive only "routine care". The abdominal pain, distension, discomfort, and satisfaction levels of the patients will be evaluated using the Visual Analogue Scale. Conclusions: New approaches are needed to improve the physiological and psychological health levels of patients after colonoscopy and help them return to their daily life activities and social lives faster. The trial will provide valuable evidence to inform clinical application and help evaluate the effects of the use of the relevant intervention.
Detailed Description
Abdominal pain, bloating, and discomfort are the most frequently problems experienced by patients undergoing colonoscopy. These problems are thought to be caused by several factors such as the duration of the process, the technical difficulty level of the process, distension caused by air insufflation, and the expertise level of the endoscopist. These problems are experienced by approximately a third of patients undergoing colonoscopy, and may last from a few hours to a few days. In a recent study, 44% of patients were found to experience such minor side effects 24 hours after colonoscopy, and 23% were found to experience them after a 30 day follow up. Although these problems are dubbed minor side effects, they may cause serious results for patients with regard to physical comfort and mental stress and may necessitate patients to be monitored post colonoscopy and followed up closely. This may lead to an increase in costs by increasing the length of hospital stay and nursing care requirements. Additionally, the satisfaction of the patients with the colonoscopy process may affect their willingness to undergo repeated colonoscopies in the future which may be required for the surveillance of colon malignity. For these reasons, decreasing post colonoscopy abdominal pain, distension, and discomfort and increasing patient satisfaction may increase the acceptance of future colonoscopy screening for colorectal cancers. Studies focused on decreasing abdominal symptoms after colonoscopy and increasing patient comfort and satisfaction have yielded varying results. For example, while some studies have reported that rectal tube application after colonoscopy reduces pain and increases patient comfort and satisfaction, in another study, it was determined that rectal tube application post colonoscopy had no effect on abdominal distension, pain, discomfort, and patient satisfaction after the process and 24 hours later. In another study, rectal aspiration applied right after colonoscopy was found to be more effective in decreasing abdominal symptoms compared to the application of rectal tubes after colonoscopy. In another study where total colonic decompression through repeating cecal intubation after colonoscopy was applied, the method was found to decrease the distension complaints of patients in the early post colonoscopy period from 59% to 25%. However, in this study, no significant difference between the groups that did and did not receive decompression with regard to abdominal pain and distension could be found 24 to 48 hours after the procedure. In yet another study, no significant difference with regard to pain intensity could be found between the aspiration of air in the curves of the colon without repeated intubation while the colonoscope was being taken out and rectal aspiration. Abdominal massaging has been shown to help improve symptoms in patients with severe constipation. In the literature, it has been reported that abdominal massage relaxes the abdominal muscles and stimulates the excretory activity by supporting the intestine, decrease discomfort and pain in individuals with abdominal pain related to cramps or flatulence, and increase the quality of life. Moreover, it is a non-invasive and safe non-pharmacological method. It has no known side effects and does not require any cost. In this study, it was assumed post-colonoscopy abdominal massage can improve their abdominal symptoms. However, to date, there is no study evaluating the effects of abdominal massage on abdominal symptoms after colonoscopy. Therefore, a prospective study was designed to evaluate the aspect of post-colonoscopy abdominal massage that concerns endoscopy nurses, namely its effect on abdominal pain, bloating, discomfort and patient satisfaction. Aim The aim of this study was to evaluate the effect of post colonoscopy abdominal massage on abdominal pain, distension, discomfort, and patient satisfaction. Null hypothesis There will be no significant difference between patients receiving abdominal massage post colonoscopy and those not receiving such an intervention with regard to abdominal pain, distension, discomfort, and patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Colonoscopy, abdominal massage, abdominal pain, abdominal distension, abdominal discomfort, patient satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abdominal Massage Group
Arm Type
Experimental
Arm Description
Abdominal massage for 15 minutes twice a day application.
Arm Title
Placebo Group
Arm Type
No Intervention
Arm Description
Abdominal massage was not applied.
Intervention Type
Other
Intervention Name(s)
Abdominal Massage
Intervention Description
Abdominal massage will be applied twice a day.
Primary Outcome Measure Information:
Title
Abdominal pain
Description
Abdominal pain will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Secondary Outcome Measure Information:
Title
Abdominal distension
Description
Abdominal distension will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Other Pre-specified Outcome Measures:
Title
Comfort
Description
Abdominal comfort will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.
Title
High Satisfaction
Description
Patient satisfaction will be evaluated with the Visual Analog Scale Zero = minimum value Ten = maximum value
Time Frame
The end of the second day.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: being of 18 years of age and above owning a cell phone having a body mass index below 30 being conscious and having location people, and time orientation having no communication barriers being able to communicate in Turkish giving written informed consent to participate in the study Exclusion Criteria: were receiving sedation having previously received intestine resection or other intestinal surgery having an uncontrolled psychopathological illness receiving colonoscopy for treatment having active lower gastrointestinal system bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DİLEK ÖZTÜRK, MSc
Organizational Affiliation
specify Unaffiliated
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aysel GÜRKAN, PhD
Organizational Affiliation
specify Unaffiliated
Official's Role
Study Director
Facility Information:
Facility Name
Prof. Dr. Cemil Taşcıoğlu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results will be shared.
IPD Sharing Time Frame
No time limit
IPD Sharing Access Criteria
No Access Criteria
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Available IPD and Supporting Information:
Available IPD/Information Type
Review
Available IPD/Information URL
https://dergipark.org.tr/tr/download/article-file/117117
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://dergipark.org.tr/tr/download/article-file/29524

Learn more about this trial

The Effect of Post Colonoscopy Abdominal Massage on Abdominal Pain, Distension, Discomfort and Patient Satisfaction

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