Perineal Massage Combined With Hip Joint Training

NCT ID: NCT06359366

Last Updated: 2024-04-11

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-10

Study Completion Date

2024-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Pelvic Floor Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
when the participants are enrolled in this study, they will be allocated to groups randomly by an independent researcher and sign the consent form. The care providers will not know the outcomes of this study, they just provide treatment for pregnant women; therefore, the care providers could be masked. an independent investigator will send a questionnaire to the participant, and the investigator does not know the intervention participants received; thus they could be masked.

Study Groups

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intervention arm

perineal massage combined hip joint training

Group Type EXPERIMENTAL

perineal massage combined hip joint training

Intervention Type PROCEDURE

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.

comparison arm

Routine antenatal examination combined self-exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zonglian Guo

nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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wenjuan wang, master

Role: PRINCIPAL_INVESTIGATOR

matron

Central Contacts

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zonglian guo, master

Role: CONTACT

+8615626450423

References

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Jaekel AK, Kirschner-Hermanns R, Knupfer SC. [Diagnostic testing of female urinary incontinence: dos and dont's]. Aktuelle Urol. 2021 Jun;52(3):237-244. doi: 10.1055/a-1492-5287. Epub 2021 May 21. German.

Reference Type BACKGROUND
PMID: 34020505 (View on PubMed)

Wang X,Li YJ,Deng ML.et al.Analysis of prevalence and risk factors of pelvic floor dysfunction in pregnant women[J].Nursing Research,2012,26(18):1636-1638

Reference Type BACKGROUND

Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

Reference Type BACKGROUND
PMID: 32378735 (View on PubMed)

Walker GJ, Gunasekera P. Pelvic organ prolapse and incontinence in developing countries: review of prevalence and risk factors. Int Urogynecol J. 2011 Feb;22(2):127-35. doi: 10.1007/s00192-010-1215-0. Epub 2010 Jul 9.

Reference Type BACKGROUND
PMID: 20617303 (View on PubMed)

Cong X. Construction of evidence-based practice plan for postpartum pelvic floor rehabilitation management [D]. Beijing University of Chinese Medicine, 2024.

Reference Type BACKGROUND

Glazener C, Elders A, MacArthur C, Lancashire RJ, Herbison P, Hagen S, Dean N, Bain C, Toozs-Hobson P, Richardson K, McDonald A, McPherson G, Wilson D; ProLong Study Group. Childbirth and prolapse: long-term associations with the symptoms and objective measurement of pelvic organ prolapse. BJOG. 2013 Jan;120(2):161-168. doi: 10.1111/1471-0528.12075. Epub 2012 Nov 27.

Reference Type BACKGROUND
PMID: 23190018 (View on PubMed)

Other Identifiers

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ShenzhenH-guo

Identifier Type: -

Identifier Source: org_study_id

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