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Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

Primary Purpose

Urinary Incontinence, Fecal Incontinence, Sexual Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic Floor Dysfunction Prevention Training
Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Sponsored by
Bitlis Eren University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Karabük Health and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control Group

Experimental Group 1

Experimental Group 2

Arm Description

Pelvic Floor Dysfunction Prevention Training

Pelvic Floor Dysfunction Prevention Training and Perineal Massage

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
July 25, 2023
Sponsor
Bitlis Eren University
Collaborators
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05624060
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bitlis Eren University
Collaborators
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Fecal Incontinence, Sexual Dysfunction, Sexuality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Pelvic Floor Dysfunction Prevention Training
Arm Title
Experimental Group 1
Arm Type
Experimental
Arm Description
Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Arm Title
Experimental Group 2
Arm Type
Experimental
Arm Description
Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Intervention Type
Behavioral
Intervention Name(s)
Pelvic Floor Dysfunction Prevention Training
Intervention Description
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
Intervention Name(s)
Pelvic Floor Dysfunction Prevention Training and Perineal Massage
Intervention Description
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
Intervention Name(s)
Pelvic Floor Dysfunction Prevention Training and Perineal Massage and Pelvic Floor Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Female Sexual Function Index
Description
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.
Time Frame
Postpartum 12th weeks
Title
The International Consultation on Incontinence Questionnaire-ICIQ
Description
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.
Time Frame
Postpartum 12th weeks
Title
Fecal Incontinence Severity Index-FISI
Description
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.
Time Frame
Postpartum 12th weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sultan Özkan Şat, PhD
Phone
05452089998
Email
sultan.ozkan25@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sultan Özkan Şat, Dr
Organizational Affiliation
Bitlis Eren University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karabük Health and Training Hospital
City
Karabük
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pınar Akbaş, PhD
Phone
+905051279014
Email
pnar.ates74@gmail.com

12. IPD Sharing Statement

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Perineal Massage and Pelvic Floor Exercise in the Antenatal Period

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