Pelvic Floor Muscle Exercises Effect After Stoma Closure

NCT04824287 | Completed

• 1 other identifier: 2018/61
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stoma

Keywords

stoma; stoma and wound care nurse; pelvic floor exercises; bowel evacuation problems; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Experimental

EXPERIMENTAL

pelvic floor exercise

Other: pelvic floor muscle exercise

control group

NO INTERVENTION

no intervention

Interventions

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

Experimental

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Wanting to leave the study,
• Having had previous biofeedback and electrical stimulation therapy applications,
• Having another stoma,
• Not being reachable by phone.

Sponsors & Collaborators

• Dilek Aktaş: lead

Study Sites (1)

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

Ankara, 06010, Turkey (Türkiye)

Location

Study Officials

• Dilek Aktaş

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Doctor

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 1, 2021
• Study Start: December 10, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)