跳至主要内容
临床试验/NCT05624060
NCT05624060已完成不适用

The Effect of Perineal Massage and Pelvic Floor Exercise Applied in the Antenatal Period on Postpartum Sexuality and Incontinence: a Randomized Controlled Study

Bitlis Eren University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Female Sexual Function Index

研究概览

简要总结

This study aimed to determine the effect of perineal massage and pelvic floor exercise in the antenatal period on sexuality and urinary and fecal incontinence in the postpartum period. This study will be conducted in a pregnant school at a state hospital in Turkey. An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

详细描述

The research was conducted as a randomized controlled trial. The simple randomization method will be used for the assignment to groups. The data of the research; will be collected using the Preliminary Evaluation Form, Personal Information Form, Female Sexual Function Index, The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version), and Fecal Incontinence Severity Index. The research will start at the 34th week of pregnancy and the questionnaires will be administered in the 3rd month after delivery. There will be 3 groups in the research.An active control group will be formed as the control group. The control group will be given the "Pelvic Floor Dysfunction Prevention Training" booklet prepared by the researchers. Experimental 1 group will receive perineal massage training in addition to the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group. Experimental 2 group will receive pelvic floor exercises in addition to perineal massage training and the "Pelvic Floor Dysfunction Prevention Training" booklet given to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • being over 18 years old,
  • being 32-34th pregnancy weeks,
  • being not experiencing any complications in the mother and fetus during pregnancy (gestational diabetes, hypertension, preeclampsia, intrauterine growth retardation, congenital anomaly, etc.),
  • having a singleton pregnancy,
  • being primiparous
  • being volunteer to participate in the study

排除标准

  • elective cesarean section planning,
  • having a history of chronic constipation,
  • having a previous history of urinary or anal incontinence,
  • having genital infection with lesions (HSV, HPV, Syphilis, Candida Albicans, Chancroid)

结局指标

主要结局

Female Sexual Function Index

时间窗: Postpartum 12th weeks

In the structure of the scale; There are 6 sub-dimensions: desire, arousal, lubrication (lubrication, wetting), orgasm, satisfaction and pain.The highest raw score that can be obtained from the scale is 95 and the lowest raw score is 4.After sub-dimension averages were multiplied by factor loads, the highest score that could be obtained from the scale was calculated as 36 and the lowest score as 2. High score means better function.

The International Consultation on Incontinence Questionnaire-ICIQ

时间窗: Postpartum 12th weeks

The International Consultation on Incontinence Questionnaire-ICIQ-SF (Turkish Version) is a scale for evaluating every aspect of urinary incontinence and its impact on quality of life.It consists of 6 questions.The ICIQ Total Score is calculated by the sum of the 3+4+5 questions and scores between 0 and 21. If the score is high and close to 21, it shows that it is overly affected.

Fecal Incontinence Severity Index-FISI

时间窗: Postpartum 12th weeks

It is an index developed to diagnose the frequency and type of fecal incontinence.It defines the type of fecal incontinence in four types and its frequency in five categories. The index score is calculated by summing the numbers corresponding to each box and the patient score. In patient-weighted scoring, the highest score that can be obtained from the index is 61 and the lowest score is 0.The cut-off score of the index is 31.7.

次要结局

未报告次要终点

研究者

发起方
Bitlis Eren University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sultan OZKAN SAT

Assistant Professor

Bitlis Eren University

研究点 (1)

Loading locations...

相似试验