Clinical trial NCT05624060: Perineal Massage and Pelvic Floor Exercise in the Antenatal Period
Official title: The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Fecal Incontinence
Sexual Dysfunction
Sexuality
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
Collaborators: name: Gazi University
First posted: 2022-11-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Female Sexual Function Index
timeFrame: Postpartum 12th weeks
measure: The International Consultation on Incontinence Questionnaire-ICIQ
timeFrame: Postpartum 12th weeks
measure: Fecal Incontinence Severity Index-FISI
timeFrame: Postpartum 12th weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karabük
country: Turkey
facility: Karabük Health and Training Hospital
Study officials:
affiliation: Bitlis Eren University
name: Sultan Özkan Şat, Dr
role: PRINCIPAL_INVESTIGATOR
References: