Perineal Massage Combined With Hip Joint Training

NCT06359366 | Not Yet Recruiting

• 1 other identifier: ShenzhenH-guo
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (2)

• pelvic floor function(constipation)

  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)

  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 Outcomes (1)

• hip motion

  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.

Study Arms (2)

intervention arm

EXPERIMENTAL

perineal massage combined hip joint training

Procedure: perineal massage combined hip joint training

comparison arm

NO INTERVENTION

Routine antenatal examination combined self-exercise

Interventions

perineal massage combined hip joint training 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.

intervention arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Related Publications (6)

• 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.

  PMID: 34020505 BACKGROUND

• 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

  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.

  PMID: 32378735 BACKGROUND

• 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.

  PMID: 20617303 BACKGROUND

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

  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.

  PMID: 23190018 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• wenjuan wang, master

  matron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zonglian guo, master

CONTACT

+8615626450423; zonglianguo@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 11, 2024
• Study Start: April 10, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after the paper has been published
• Access Criteria: the detail in clinicaltrial.gov