Pelvic Floor Muscle Exercises Effect After Stoma Closure

Stoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04824287
• Other study ID #: 2018/61
• Status: Completed
• Phase: N/A
• Start date: December 10, 2018
• Est. completion date: May 5, 2020

Study information

• Verified date: March 2021
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 5, 2020
• Est. primary completion date: May 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stoma

Intervention

Other:
• pelvic floor muscle exercise
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

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dilek Aktas

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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