Pelvic Floor Muscle Exercises Effect After Stoma Closure

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

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.

Study Overview

• Status: Completed
• Conditions: Stoma
• Intervention / Treatment: Other: pelvic floor muscle exercise

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; pelvic floor exercise	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
NO_INTERVENTION: control group; no intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dilek Aktaş
• Investigators: Principal Investigator: Dilek Aktaş, Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2018
• Primary Completion (ACTUAL): May 5, 2020
• Study Completion (ACTUAL): May 5, 2020

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: March 27, 2021
• First Posted (ACTUAL): April 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 27, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; stoma; pelvic floor exercises; stoma and wound care nurse; bowel evacuation problems
• Other Study ID Numbers: 2018/61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No