The Effect of Perineal Massage Combined With Hip Joint Training on Pelvic Floor Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- pelvic floor function (urinary incontinence score)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton pregnant women
- •primipara;
- •signed informed consent voluntarily
- •36 weeks gestation;
- •no pregnancy complication
排除标准
- •pluripara;
- •multiple pregnancies;
- •pregnant women with mental or cognitive disabilities;
- •scarred uterus;
- •pelvic surgery history;
- •urinary incontinence before pregnancy history;
- •obstipation before pregnancy history
结局指标
主要结局
pelvic floor function (urinary incontinence score)
时间窗: 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.
pelvic floor function(constipation)
时间窗: 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.
次要结局
- 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.)
研究者
Zonglian Guo
nurse
Shenzhen Hospital of Southern Medical University