Health Sciences University Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Turkey (Türkiye)
NCT Number: NCT07570004
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)."
Time frame: preoperative period and postoperative 24. hour
Stool type: hard/normal
Burcu Ozkan
Other
The Effect of Preoperative Abdominal Massage on The Development of Postoperative Constipation: A Randomised Controlled Study
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