Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

January 16, 2025 updated by: Sultan OZKAN SAT, Bitlis Eren University

The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: a Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Karabük, Turkey
        • Karabük Health and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Control Group
Pelvic Floor Dysfunction Prevention Training
Behavioral: 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.
Experimental: Experimental Group 1
Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Behavioral: 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.
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.
Experimental: Experimental Group 2
Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Behavioral: 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Female Sexual Function Index
Time Frame: 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.
Postpartum 12th weeks
The International Consultation on Incontinence Questionnaire-ICIQ
Time Frame: 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.
Postpartum 12th weeks
Fecal Incontinence Severity Index-FISI
Time Frame: 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.
Postpartum 12th weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bitlis Eren University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sultan Özkan Şat, Dr, Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SULTANOZKANSAT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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