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Completed

NCT Number: NCT04824287

Pelvic Floor Muscle Exercises Effect After Stoma Closure

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.

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Key information

Conditions

Stoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pelvic floor muscle exercise

Other

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

Primary outcomes

  1. Bowel Evacuation Habits

    Time frame: 6 month

    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

  2. Wexner Scale Score

    Time frame: 6 month

    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

  3. Psychosocial Problems

    Time frame: 6 month

    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

  4. Health-related Quality of Life

    Time frame: 6 month

    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

Sponsors and collaborators

Lead sponsor

Dilek Aktaş

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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