Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

NCT05624060 | Completed

• 1 other identifier: SULTANOZKANSAT
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Fecal Incontinence; Sexual Dysfunction; Sexuality

Outcome Measures

Primary Outcomes (3)

• Female Sexual Function Index

  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.

  Postpartum 12th weeks

• The International Consultation on Incontinence Questionnaire-ICIQ

  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.

  Postpartum 12th weeks

• Fecal Incontinence Severity Index-FISI

  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.

  Postpartum 12th weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

Pelvic Floor Dysfunction Prevention Training

Behavioral: Pelvic Floor Dysfunction Prevention Training

Experimental Group 1

EXPERIMENTAL

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Behavioral: Pelvic Floor Dysfunction Prevention Training; Behavioral: Pelvic Floor Dysfunction Prevention Training and Perineal Massage

Experimental Group 2

EXPERIMENTAL

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

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

Interventions

Pelvic Floor Dysfunction Prevention Training 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.

Control Group; Experimental Group 1; Experimental Group 2

Pelvic Floor Dysfunction Prevention Training and Perineal Massage 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 1; Experimental Group 2

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

Experimental Group 2

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bitlis Eren University: lead
• Gazi University: collaborator

Study Sites (1)

Karabük Health and Training Hospital

Karabük, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence; Fecal Incontinence; Sexual Dysfunction, Physiological; Sexuality

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Genital Diseases; Sexual Behavior; Behavior

Study Officials

• Sultan Özkan Şat, Dr

  Bitlis Eren University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: February 1, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: January 17, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)