Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

Not Applicable

Completed

• Conditions: Urinary Incontinence; Fecal Incontinence; Sexual Dysfunction; Sexuality
• Interventions: Behavioral: Pelvic Floor Dysfunction Prevention Training; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

• Registration Number: NCT05624060
• Lead Sponsor: Bitlis Eren University

Brief Summary

This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

Detailed Description

The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

Study Timeline

• Study First Submitted: 2022-11-13
• Study First Submitted QC: 2022-11-13
• Study First Posted: 2022-11-21
• Study Start: 2023-02-01
• Status Verified: 2023-11
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-20
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• being over 18 years old,
• being 32-34th pregnancy weeks,
• being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
• having a singleton pregnancy,
• being primiparous
• being volunteer to participate in the study

Exclusion Criteria

• elective cesarean section planning,
• having a history of chronic constipation,
• having a previous history of urinary or anal incontinence,
• having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group 1	Pelvic Floor Dysfunction Prevention Training	Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Experimental Group 2	Pelvic Floor Dysfunction Prevention Training	Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Control Group	Pelvic Floor Dysfunction Prevention Training	Pelvic Floor Dysfunction Prevention Training
Experimental Group 2	Pelvic Floor Dysfunction Prevention Training and Perineal Massage	Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Experimental Group 1	Pelvic Floor Dysfunction Prevention Training and Perineal Massage	Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Experimental Group 2	Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise	Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index	Postpartum 12th weeks	In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain.The highest raw score that can be obtained from the scale is 95 and the lowest raw score is 4.After sub-dimension averages were multiplied by factor loads, the highest score that could be obtained from the scale was calculated as 36 and the lowest score as 2. High score means better function.
The International Consultation on Incontinence Questionnaire-ICIQ	Postpartum 12th weeks	The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version) is a scale for evaluating every aspect of urinary incontinence and its impact on quality of life.It consists of 6 questions.The ICIQ Total Score is calculated by the sum of the 3+4+5 questions and scores between 0 and 21. If the score is high and close to 21, it shows that it is overly affected.
Fecal Incontinence Severity Index-FISI	Postpartum 12th weeks	It is an index developed to diagnose the frequency and type of fecal incontinence.It defines the type of fecal incontinence in four types and its frequency in five categories. The index score is calculated by summing the numbers corresponding to each box and the patient score. In patient-weighted scoring, the highest score that can be obtained from the index is 61 and the lowest score is 0.The cut-off score of the index is 31.7.

Trial Locations

Locations (1)

Karabük Health and Training Hospital; 🇹🇷 Karabük, Turkey