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Pelvic Floor Muscle Exercises Effect After Stoma Closure

D

Dilek Aktaş

Status

Completed

Conditions

Stoma

Treatments

Other: pelvic floor muscle exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04824287
2018/61

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Experimental
Experimental group
Description:
pelvic floor exercise
Treatment:
Other: pelvic floor muscle exercise
control group
No Intervention group
Description:
no intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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