An interventional study of perineal massage combined hip joint training in Pelvic Floor Disorders, sponsored by Shenzhen Hospital of Southern Medical University. Not yet recruiting. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Shenzhen Hospital of Southern Medical University · Not applicable, Interventional, and Treatment
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
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.
197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.
This study's planned enrollment of 108 is above the median of 64 across 136 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Shenzhen Hospital of Southern Medical University is the lead sponsor of 9 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
perineal massage combined hip joint training
Procedure: perineal massage combined hip joint training
Routine antenatal examination combined self-exercise
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.
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.
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.
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.
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.
hip motion
The standard human range of motion scale(hip motion scale). Hip motion was measured under different exercise types.
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.
No study locations are listed for this record.
Plan to share: Yes — study protocol could be share with others
Supporting information: Study protocol
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Shenzhen Hospital of Southern Medical University