The Effect of Training Based on the Transtheoretical Model on Pelvic Floor Muscle Strength

NCT07443423 | Not Yet Recruiting DMC

• 1 other identifier: 26-1T/83
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study was designed to evaluate the effect of training based on the transtheoretical model on pelvic floor muscle strength in women. The study was designed as a randomized controlled single-blind experimental study with pre-test and post-test measurements and will be conducted with sexually active women aged 18 and over who meet the inclusion criteria and who applied to the Sevgi Family Health Center No. 13 in Gaziemir District, Izmir Province.

Conditions

Pelvic Floor Awareness

Keywords

Pelvic Floor Exercises; Transtheoretical Model; Randomized Controlled Trial; Health Education, Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in pelvic floor muscle activity (Microvolts µV)

  The maximum voluntary contraction (MVC) and average contraction of the pelvic floor muscles will be measured using a surface EMG biofeedback device.Higher values indicate improved muscle activation and strength.

  Baseline (week 0) and Post-intervention( week 8)

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Group not receiving training

Other: Not providing training

Experimental group

EXPERIMENTAL

Other: TRAINING BASED ON THE TRANSTEOROTİK MODEL

Interventions

Not providing training OTHER

Once the data collection phase of the study is complete, women in the control group will also be given a detailed explanation of pelvic floor muscle exercises based on the transtheoretical model and awareness training, and will be provided with a brochure.

Control Group

TRAINING BASED ON THE TRANSTEOROTİK MODEL OTHER

Women in the intervention group will receive awareness training on pelvic floor muscle exercises based on the transtheoretical model. This training includes a brochure and a seminar program prepared according to the transtheoretical model. A monthly exercise schedule will be provided to the women in this group to support them in performing pelvic floor muscle exercises.

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sexually active women aged 18-65
• Women who volunteered to participate in the study

You may not qualify if:

• Those with a perinometer measurement result of 2
• Pregnant women
• Those who have undergone pelvic floor muscle training in the last two years
• Those with conditions that prevent them from performing Pelvic Floor Muscle Exercises
• Those who use a mobile application for Pelvic Floor Muscle Exercises
• Those with Pelvic Floor Dysfunction
• Those who are unable to perform the Pelvic Floor exercise program -

Sponsors & Collaborators

• Aynur Erçek Karci: lead

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Midwife

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: March 2, 2026
• Study Start: March 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 6 months after publication. Ending 36 months after publication.