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Not yet recruiting NCT07443423

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

No phase Interventional Pelvic Floor Awareness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRAINING BASED ON THE TRANSTEOROTİK MODEL, Not providing training.
Who it may be relevant to
Registry conditions: Pelvic Floor Awareness. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Transtheoretical Model-Based Training on Pelvic Floor Muscle Strength in Women: Creating an Application-Oriented Training Model

Overview

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.

Detailed description

The pelvic floor is a complex anatomical structure composed of nerve, muscle, fascia, and connective tissue components. Working in conjunction with other muscles associated with the pelvic girdle, the pelvic floor is a vital component responsible for stabilizing the entire body. The primary functions of the pelvic floor and its components include providing support to intra-abdominal structures such as the bladder, urethra, prostate, vagina, uterus, anus, and rectum; supporting continence by enabling the voluntary initiation and cessation of urination and defecation, thus preventing incontinence; preventing pelvic organ prolapse; playing an active role during childbirth; and maintaining sexual function .

Pelvic floor dysfunction (PFD) manifests with various complex symptoms such as urinary incontinence (UI), pelvic organ prolapse (POP), fecal incontinence (FI), sexual problems, and chronic pelvic pain, alongside damage, weakening, and impairment of the pelvic floor's function and morphological structure. affecting women's daily activities, psychosocial status, and overall health perception . Pelvic floor dysfunction is a common problem worldwide, occurring at rates ranging from 1.9% to 46.5%, and is underdiagnosed. In Turkey, the prevalence of pelvic organ prolapse is 30-50%, urinary incontinence is 26.3-71.5%, and fecal/anal incontinence is reported in the literature as 2-3%. it is reported that this rate increases with age, exceeding 10%, and that the rate of sexual dysfunction in women ranges from 20% to 73% stated in their article that approximately 10% of women face pelvic floor problems requiring surgery . Although it varies between countries and societies, the prevalence of pelvic floor dysfunction in women generally ranges between 20-40% .These rates indicate that pelvic floor dysfunction is a significant public health issue.

The treatment and care interventions for pelvic floor dysfunction are a preventive health service that healthcare professionals, particularly midwives in primary healthcare institutions, should prioritize. Providing education on pelvic floor strengthening is important both in preventing misconceptions and in increasing women's knowledge and awareness levels.

A systematic review conducted to determine the effectiveness of health promotion interventions based on behavioral change models for modifying lifestyle factors (physical activity, diet, alcohol, and smoking) in adults receiving primary health care found that the Transtheoretical Model was the most frequently used intervention for these purposes. The Transtheoretical Model was developed by Prochaska and Diclemente to guide individuals in accepting problematic behaviors in their lives and changing these behaviors with positive expectations and desire. This model aims to change the individual's behavior intentionally. It is recommended that the Transtheoretical Model be used to facilitate individuals' adaptation to lifestyle changes and to provide effective education also stated in their studies that care provided in conjunction with pelvic floor training prevents pelvic floor dysfunction and improves quality of life .

Interventions

  • Other TRAINING BASED ON THE TRANSTEOROTİK MODEL
    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.
  • Other Not providing training
    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.

Primary outcome measures

  • Change in pelvic floor muscle activity (Microvolts µV) [Time frame: Baseline (week 0) and Post-intervention( week 8)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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 -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07443423 · 26-1T/83

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗