Comparison of Teaching Methods of Pelvic Floor Muscle Contraction in Women

NCT06306703 | Not Yet Recruiting DMC

• 1 other identifier: PhD Thesis of Duygu Sultan Oge
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study; To evaluate the effectiveness of different teaching methods on correct pelvic floor muscle contraction in women who have not received pelvic floor muscle training (PFMT) before. Women who come to the gynecology and obstetrics clinic for examination and volunteer for the study will be randomized with a computer-aided randomization program and divided into 3 groups. First of all, the pelvic floor muscles will be evaluated by ultrasonographic method and perineometer. The first group will be taught pelvic floor muscle contraction with verbal explanation, the second group will be taught with digital vaginal palpation, and the third group will be taught pelvic floor muscle contraction with the help of a perineometer. After the training, the same evaluations will be made again. The number of individuals to be included in the study will be determined by power analysis. As a result of this study, it will be decided which method can be used to teach pelvic floor muscle contraction to women accurately and effectively in clinics. The results of our study will guide clinicians in their preferences for using different teaching methods.

Conditions

Pelvic Floor Muscle Weakness

Keywords

pelvic floor muscle contraction; pelvic floor assessment

Outcome Measures

Primary Outcomes (3)

• ASSESSMENT OF THE PELVIC FLOOR USING ULTRASONOGRAPHY (USG)

  During evaluation with 2D USG, hiatal aperture measurements will be made at rest and at maximum voluntary contraction. Measurements will be repeated before and after individuals receive training, and any numerical changes that may occur will be recorded\[11,12\].

  at the beginning 5 minutes, at the end 5 minutes

• Pelvic Floor Muscle Strength and Endurance:

  Pelvic floor muscle strength and endurance will be evaluated with a non-invasive vaginal perineometer with digital vaginal palpation

  5 minutes

• pelvic floor power, minimum and maximum muscle contraction values

  Pelvic floor power will be evaluated with intravajinal biofeedback electromyograhy(EMG)

  5 minutes

Secondary Outcomes (9)

• DETAILED STORIES OF THE PATIENTS

  5 minutes

• Pelvic Floor Health Knowledge Test:

  5 minutes

• Global Pelvic Floor Disorder Questionnaire(GPFDQ)

  5 minutes

• Visual Analog Scale (VAS) assessment for pelvic pain

  1 minute

• Determining the severity of incontinence

  1 minute

Study Arms (3)

group1, verbal instruction

EXPERIMENTAL

Other: group1, group2, group 3

group 2, digital vaginal palpation

EXPERIMENTAL

Other: group1, group2, group 3

group 3, perineometer

EXPERIMENTAL

Other: group1, group2, group 3

Interventions

group1, group2, group 3 OTHER

to teaching with verbal instruction to teaching with digital vaginal palpation to teaching with perineometer

group 2, digital vaginal palpation; group 3, perineometer; group1, verbal instruction

Eligibility Criteria

• Age: 20 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• volunteering to participate in the study, getting a score of 25 or more from the "Mini mental Test", having pelvic floor muscle contraction ability, not having received pelvic floor muscle training before, vaginal examination and volunteering for education.

You may not qualify if:

• Pregnancy, presence of symptomatic pelvic organ prolapse over stage 2, cooperation problem, presence of urinary infection, epilepsy, and accompanying neurological disease.

Sponsors & Collaborators

• Duygu Sultan Oge: lead

Study Officials

• Türkan Akbayrak, Prof

  Hacettepe Universty

  STUDY DIRECTOR

Central Study Contacts

Duygu Sultan Öge, MsC

CONTACT

+905052252783; sltnoge@gmail.com

Türkan Akbayrak, Prof

CONTACT

+905326587236; takbayrak@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: healthcare provider performing USG evaluation person doing statistical analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: student

Model Details: prospective randomized

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: August 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share