The Effect of Pelvic Floor Muscle Exercise on Sexual Function in Women of Reproductive Age:A Randomized-Controlled Tria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Distribution of participants into groups
研究概览
简要总结
The goal of this evaluate the effect of pelvic floor muscle exercises on sexual function in women of reproductive age. A randomized controlled trial was conducted in a sample of women of reproductive age, 77 women were randomly assigned to control (n=39) and training (n=38) groups. A form including questions regarding socio-demographic characteristics and the Female Sexual Function Index was applied to all women included in the study. Pelvic floor exercise training was given to the women in the training group and the Female Sexual Function Index was applied to both groups in the 1st, 2nd, and 3rd months. The differences between those who received and those who did not receive training and the effects of regular pelvic exercise on sexual function were evaluated by month.
Research Hypotheses H1: Sexual function scores of women of reproductive age who regularly perform pelvic floor muscle exercises are higher than those who do not exercise.
H2: Sexual function scores are higher for those who regularly exercise their pelvic floor muscles for at least two months
详细描述
The research has a prospective, randomized controlled design.
Inclusion criteria of the study:
Women aged between 18-49 who agreed to participate in the study and who had a regular sexual life were included in the study.
Exclusion criteria of the study:
Women who did not have a regular sex life, who had undergone an operation that prevented them from doing pelvic floor exercises, and who exercised regularly because it could strengthen the pelvic muscles and affect the results of the study were excluded from the study. In addition, menopausal women were not included in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-49
- •Women who have not entered menopause
- •Women with regular sexual life.
排除标准
- •Women in menopause
- •Women diagnosed with gynecological cancer
- •Women who do not have a regular sexual life
结局指标
主要结局
Distribution of participants into groups
时间窗: Baseline (Before training)
The sample group was randomly divided into training and control. The study protocol for the trial was created using SPIRIT guidelines and the trial reporting was created according to the CONSORT checklist. In order to avoid selection bias in the study, patients were assigned to the experimental and control groups with the block randomization method. The n=80 samples included in the study were randomly divided into case (n=40) and control (n=40) groups with the help of the "Random Allocation Software" computer program.
Initial scale application
时间窗: Baseline (Before training)
Women's Descriptive Characteristics: The form was prepared by the researcher in line with the literature and consists of 23 questions regarding sociodemographic characteristics, general health status, and obstetric characteristics of women. Female Sexual Function Index (FSFI): The scale was created by Rosen et al. in 2000 in order to evaluate sexual function. It includes 19 questions and evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain in a multidimensional way. The highest raw score obtainable from the index is 36 and the lowest raw score is 2. An increase in the scores on the total index and the sexual desire, arousal, lubrication, orgasm, and general satisfaction subscales indicate an improvement in all these parameters.
Determining Number of Participants
时间窗: Baseline (Before training)
Power calculation was made to determine the size of the sample constituting the training and control groups. In the power analysis performed for the training and control groups in line with the literature data \[(SD±6.5) with an α of 5% and a power of 80% (1-ß)\], the expected sample size was determined as a total of 68 people, 34 in the training group and 34 in the control group13. However, considering the possible data loss, it was decided to include 40 individuals in each group. Data were collected using Google Forms through social media platforms. Women who volunteered to participate in the study were invited and written consent was taken from the individuals included in the study. 80 women who agreed to participate were included in the study of women who agreed to participate in the study. Sample group n=80
次要结局
- Female Sexual Function Index(3st Month)
- Providing pelvic floor exercise for training group(Baseline (Before training))
研究者
Serap Tekbas
Principal Investigator
Izmir Tinaztepe University