Perineal Massage Combined With Hip Joint Training

April 5, 2024 updated by: Zonglian Guo, Shenzhen Hospital of Southern Medical University

The Effect of Perineal Massage Combined With Hip Joint Training on Pelvic Floor Function

The goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. The main questions it aims to answer are:

Does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? Does the perineal massage combined with hip joint training improve the flexibility of the hip joint? Researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function.

Participants will:

receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete Demographic sociological , ICI-Q-LF, Wexner constipation and hip motion questionnaires

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Women experience varying degrees of damage to the female reproductive and urinary muscle groups during pregnancy and delivery, which can lead to a series of pelvic floor disorders, for example, pelvic organ prolapse (POP), urinary incontinence(UI), chronic constipation (CC) and other syndrome, reducing the quality of life.

This study examined the effect of perineal massage combined with hip joint training on pelvic floor function, especially on UI, CC and hip motion. This is a parallel randomised control trial. The researchers will recruit participants from the obstetrics outpatient ward. Pregnant women attending the maternity clinic who met the inclusion and exclusion criteria will be randomly selected and sign informed consent, then the enrolled population was randomly assigned to each group using sealed envelopes.

The intervention group will receive perineal massage combined with hip joint training; the comparison group will receive regular training.

The primary outcome is the ICI-Q-LF score; Wexner constipation score; and the secondary outcome is hip motion.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • 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

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • singleton pregnant women
  • primipara;
  • signed informed consent voluntarily
  • 36 weeks gestation;
  • no pregnancy complication

Exclusion Criteria:

  • pluripara;
  • multiple pregnancies;
  • pregnant women with mental or cognitive disabilities;
  • scarred uterus;
  • pelvic surgery history;
  • urinary incontinence before pregnancy history;
  • obstipation before pregnancy history

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention arm
perineal massage combined hip joint training
Procedure: perineal massage combined hip joint training
pregnant women take the lithotomy position, disinfect the vulva, and wear sterile gloves. Then thumbs, forefingers, and middle fingers dip massage oil to do a 2 minutes pressurized dilatation massage from inside to outside gently to loosen the fascia. Then rest 30s. All steps need to be repeated 2 to 3 times. When the pregnant women feel a slight sense of acidity and tingling sensation disappears, researchers sterilize the perineal body again. left side pelvic floor receives the same intervention as right. The whole process takes 15-20min, 5 times a week until delivery. Additionally, while using the pelvic floor fascia manipulation, pregnant women are instructed to perform specific movements of internal and external hip rotation, adduction and abduction, upward and downward.
No Intervention: comparison arm
Routine antenatal examination combined self-exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pelvic floor function(constipation)
Time Frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
using the Wexner Constipation Scoring System (lowest score, 0; Highest score, 30, contain 8 questions) to assess the outcomes of constipation. total score greater than 15 indicates constipation.the higher the score, the more difficult it is to defecate.
the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
pelvic floor function (urinary incontinence score)
Time Frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
using the ICI-Q-SF (containing 4 questions) to assess the degree of urinary incontinence. the higher the score, the worse the incontinence.
the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hip motion
Time Frame: the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.
The standard human range of motion scale(hip motion scale). Hip motion was measured under different exercise types.
the outcomes will be assessed at 1.before the first time intervention at 36 gestational age. 2.receive intervention 10 times during two weeks(5 times/week). the results will reported through study completion, an average 3 months.

Collaborators and Investigators

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

Sponsor

Shenzhen Hospital of Southern Medical University

Investigators

  • Principal Investigator: wenjuan wang, master, matron

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 10, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShenzhenH-guo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol could be share with others

IPD Sharing Time Frame

after the paper has been published

IPD Sharing Access Criteria

the detail in clinicaltrial.gov

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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