- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07570004
The Effect of Preoperative Abdominal Massage on Postoperative Constipation
The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study
The aim of this clinical study is to determine whether preoperative abdominal massage has an effect on the development of postoperative constipation. The main questions it aims to answer are:
• Does preoperative abdominal massage improve postoperative stool consistency? • Does preoperative abdominal massage prevent constipation? To see if abdominal massage is effective in preventing constipation, researchers will not apply any treatment to the second group and will compare the two groups.
Participants will:
- Provide researchers with information about their preoperative and postoperative stool consistency and constipation status.
- Inform the researchers if the group that received the massage experiences any adverse effects from the massage.
Study Overview
Detailed Description
Abdominal massage, being a low-cost, non-invasive procedure with no known harmful side effects, and one that nurses can integrate into clinical practice, plays an important role in the management of constipation.
This study is a single-center, randomized controlled experimental trial planned to be conducted in the General Surgery Department of a Training and Research Hospital in Istanbul. Standard operating procedures for patient recruitment, data collection, data management, adverse event reporting, and change management processes have been predefined. The experimental group will receive abdominal massage twice daily for 15 minutes, while the control group will continue with routine care. Adverse events will be recorded after each session, and necessary protocol changes will be documented in accordance with formal change management procedures. The sample size was determined based on a power analysis performed with G*Power 3.1; 30 participants were planned for each group (total n=60; α=0.05, power=0.80). A complete case analysis approach will be adopted for missing data resulting from data inconsistencies, out-of-range results, or unanswered items, and group assignments will continue until data is complete. In accordance with the statistical analysis plan, the Mann-Whitney U test will be used for between-group comparisons and the Wilcoxon test for within-group comparisons for the Bristol Stool Scale (BSS) score, which is the primary outcome measure; For the secondary outcome measure, stool type distribution, the Chi-square test will be applied. Effect size will be reported using Cohen's d and odds ratio, and the statistical significance threshold will be set at p<0.05.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye)
- Health Sciences University Sultan Abdülhamid Han Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Being hospitalized in the General Surgery Department
- Experiencing constipation
- Being 18 years of age or older
- Having the cognitive ability to answer questions
- Voluntary participation in the study
Exclusion criteria:
- Being under 18 years of age
- Not experiencing constipation
- Having a condition that contraindicates abdominal massage (active intra-abdominal pathology, open wound, thrombocytopenia, etc.)
- Insufficient cognitive ability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
|
|
|
Experimental: Abdominal Massage İnterventional Group
Massage Group
|
The procedure will be followed using a protocol prepared by researchers based on a literature review.
Massage sessions are scheduled for 10:00 AM and 4:00 PM, 30 minutes after a meal.
The massage duration is 15 minutes.
The frequency of massage is twice a day.
Necessary tools and equipment include liquid petroleum jelly and a towel.
The massage techniques include effleurage (superficial and deep), petrissage, and vibration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BSS score
Time Frame: BSS score preoperative period and postoperative 24. hour
|
According to the Bristol Stool Scale, a score of 1-2 indicates "hard stools," 3-4-5 indicates "normal stools," and 6-7 indicates "soft-watery stools (diarrhea)."
|
BSS score preoperative period and postoperative 24. hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool type distribution/constipation
Time Frame: preoperative period and postoperative 24. hour
|
Stool type: hard/normal
|
preoperative period and postoperative 24. hour
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- McClurg D, Lowe-Strong A. Does abdominal massage relieve constipation? Nurs Times. 2011 Mar 29-Apr 4;107(12):20-2.
- Celik S, Atar NY, Ozturk N, Mendes G, Kuytak F, Bakar E, Dalgiran D, Ergin S. Constipation risk in patients undergoing abdominal surgery. Iran Red Crescent Med J. 2015;17(6):e23632. doi: 10.5812/ircmj.23632
- 1. Olgun S, Eser I. The effect of abdominal massage on chronic constipation and constipation quality of life in elderly: a randomized controlled trial. Int J Med Res Health Sci. 2021;10(6):20-30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24/11/2022-984
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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