Pelvic Floor Muscle Exercises Effect After Stoma Closure

Study Overview
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Brief Summary
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This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel evacuation problems and quality of life in individuals after stoma closure.

Detailed Description
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Sample of study was calculated as 32 using G*Power Software (ver. 3.1.9.2) for 80% power and medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al. Participants were assigned to the experimental and control groups by the stratified block randomization method. The locks were assigned to layers using Microsoft Excel. The individuals in the experimental group received pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training. The patients received a PFME training booklet prepared by the researcher. Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery. Data was collected a day before discharge, first, second, third, and sixth months after the surgery.

Official Title
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The Effect of Pelvic Floor Muscle Exercises on Bowel Evacuation Problems and Quality of Life in Individuals With Closed Stoma

Conditions
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Stoma

Intervention / Treatment
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* Other: pelvic floor muscle exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being between the ages of 18 and 75, Being literate, Having a stoma due to colorectal cancer, Having no previous anal trauma, Having no anal surgery other than colorectal cancer surgery, Having no congenital anorectal anomaly, Having no neurological problem, Having no physical disability, Having no previous experience of PFMEs before the surgery, Being cognitively able to answer questions Exclusion Criteria: Wanting to leave the study, Having had previous biofeedback and electrical stimulation therapy applications, Having another stoma, Not being reachable by phone.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>pelvic floor exercise | Other: pelvic floor muscle exercise<br>* pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery Patients practiced exercises 6 month after surgery<br>|
| No Intervention: control group<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Evacuation Habits | evaluated with Assessment Form for Bowel Evacuation Habits and Psychosocial Problems. This form was developed by the researcher. Patients answer the question yes or no | 6 month | 
| Wexner Scale Score | Wexner Scale used to evaluate fecal incontinence. Minimum point is 0 an maximum point is 20. A score of 1 or above indicates a fecal incontinence problem | 6 month | 
| Psychosocial Problems | evaluated with Assessment Form for Bowel Evacuation Habits and Psychosocial Problems. This form was developed by the researcher. The form include questions about psychosocial problems related bowel evacuation problems Patient answer the questions yes or no | 6 month | 
| Health-related Quality of Life | evaluated with Short Form 36 (SF-36) Health-related Quality of Life Scale. This scale include 8 subdimensions. scale does not have a single total score: the score for each dimension is calculated separately. For each subdimension minimum point is 0 and maximum point is 100. Higher score indicate best quality of life | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stoma, stoma and wound care nurse, pelvic floor exercises, bowel evacuation problems, quality of life