Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

NCT ID: NCT05624060

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-11-20

Brief Summary

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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

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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.

Conditions

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Urinary Incontinence Fecal Incontinence Sexual Dysfunction Sexuality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control Group

Pelvic Floor Dysfunction Prevention Training

Group Type ACTIVE_COMPARATOR

Pelvic Floor Dysfunction Prevention Training

Intervention Type BEHAVIORAL

The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.

Experimental Group 1

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Group Type EXPERIMENTAL

Pelvic Floor Dysfunction Prevention Training

Intervention Type BEHAVIORAL

The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Intervention Type BEHAVIORAL

Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Experimental Group 2

Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Group Type EXPERIMENTAL

Pelvic Floor Dysfunction Prevention Training

Intervention Type BEHAVIORAL

The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Intervention Type BEHAVIORAL

Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Intervention Type BEHAVIORAL

Women assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Interventions

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Pelvic Floor Dysfunction Prevention Training

The "Pelvic Floor Dysfunction Prevention Training" booklet is cover weight control, perineal hygiene, adequate fluid consumption, not smoking and alcohol use, avoidance of spicy, fizzy and fatty foods and beverages, correct posture and frequency of micturition, prevention of constipation and abdominal pressure.

Intervention Type BEHAVIORAL

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Intervention Type BEHAVIORAL

Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise

Women assigned to this group will apply pelvic floor exercise at least 3 days a week 8-12 times a week, starting from the 34th week of pregnancy until delivery. In addition, women will apply perineal massage for an average of 8-10 minutes at least twice a week, starting from the 34th week of pregnancy until delivery. In addition to perineal massage, the "Pelvic Floor Dysfunction Prevention Training" booklet will be given to participant.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role collaborator

Bitlis Eren University

OTHER

Sponsor Role lead

Responsible Party

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Sultan OZKAN SAT

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sultan Özkan Şat, Dr

Role: PRINCIPAL_INVESTIGATOR

Bitlis Eren University

Locations

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Karabük Health and Training Hospital

Karabük, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SULTANOZKANSAT

Identifier Type: -

Identifier Source: org_study_id

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