The Effect of Reiki on Sexual Function and Sexual Self-Confidence in Women With Sexual Distress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Female Sexual Distress Scale-Revised (FSDS-R)
研究概览
简要总结
Background and Purpose: This study aimed to determine the effect of Reiki on sexual function and sexual self-confidence in women with sexual distress.
Materials and Methods: This randomized controlled study was conducted with women between the ages of 15-49 years who were registered at a family health center in the eastern region of Turkey and had sexual distress. The sample of the study consisted of 106 women, 53 in the experimental group and 53 in the control group. Women in the experimental group received Reiki once a week for four weeks, while no intervention was applied to those in the control group. Data were collected using the Female Sexual Distress Scale-Revised (FSDS-R), the Arizona Sexual Experiences Scale (ASEX), and the Sexual Self-confidence Scale (SSS).
详细描述
- Methods 2.1. Research Design and Sample In this randomized controlled study, participants were randomly assigned to the experimental (Reiki group) or control groups. The study was conducted using women between the ages of 15-49 years who were registered at a Family Health Center in a province of eastern Turkey. This primary healthcare center provides reproductive health services to women such as family planning, education, and counseling, and includes 3 family physicians and 3 family health workers (midwives and/or nurses). The center was randomly selected considering its socioeconomic environment, proximity to the city center, and registered number of women. The center serves approximately 21,000 people, including around 1600 women. Additionally, there is a quiet and peaceful room in the center to hold Reiki sessions. Women who agreed to participate in the study and met the study inclusion criteria were included in the study.
The study inclusion criteria were as follows: being a woman, scoring 11.5 or above on the Female Sexual Distress Scale-Revised (FSDS-R), and being sexually active during the study. The study exclusion criteria were as follows: being pregnant or postpartum, having a diagnosis of any psychiatric illness or sexual dysfunction.
The sample size was determined using OpenEpi (Open Source Epidemiologic Statistics for Public Health) version 3.1, a web-based program. A priori power analysis was performed to estimate the appropriate sample size. As the primary outcome of the study, the mean sexual life score was determined to be 13.70 (with a standard deviation of 5.48) in the literature review. The sample size was calculated as 53 for each group (53 for the experimental group and 53 for the control group) assuming a 5% two-tailed type I error rate, 95% confidence interval, 80% power to represent the population, and a 3-point increase in sexual life score after the intervention.
To reach the sample size, a total of 200 women were evaluated for eligibility criteria. Of them, 47 did not meet the inclusion criteria and 25 refused to participate in the study. In addition, 13 out of 67 women in the experimental group were excluded from the study as they did not continue to participate in Reiki sessions, while 8 out of 61 women in the control group were excluded from the study because they did not want to continue participating in the study. The study was completed with a total of 106 women, 53 in the experimental group and 53 in the control group.
2.2. Randomization Women who agreed to participate in the study and met the inclusion criteria were randomly assigned to experimental and control groups in the order of their arrival at the Family Health Center. A randomization was performed using the Random Integer Generator method, which can be found in the Numbers subsection of the random.org website. Single-column tables were created using numbers from 1 to 106 (https://www.random.org/). Women who referred to the Family Health Center were randomly assigned to numbers 1 and 2 in the column, considering the numbers 1 and 2. The decision of which number would correspond to the experimental or control group was determined by drawing lots. The number 1 was assigned to the experimental group and the number 2 to the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
This study was designed as a randomized controlled trial
入排标准
- 年龄范围
- 15 Years 至 49 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being a woman,
- •Scoring 11.5 or above on the Female Sexual Distress Scale-Revised (FSDS-R)
- •Being sexually active during the study.
排除标准
- •being pregnant or postpartum
- •having a diagnosis of any psychiatric illness or sexual dysfunction
结局指标
主要结局
Female Sexual Distress Scale-Revised (FSDS-R)
时间窗: Change from Sexual Distress at 4 weeks
The FSDS-R was assesses various aspects of sexual distress in women, including subjective stress and psychological impact associated with sexual dysfunction and is used to identify women with and without sexual dysfunction. The scale consists of 13 items on a five-point Likert scale ranging from never (0) to always. Total scale score ranges between 0 and 52. A higher score indicates higher levels of sexual distress. A cutoff score of ≥11.5 has been recommended to detect the presence of sexually-related personal distress in Turkish women.
次要结局
- Sexual Self-confidences Scale (SSS)(Change from Sexual Self-confidences at 4 weeks)
- Arizona Sexual Experiences Scale (ASEX)(Change from Sexual Experiences at 4 weeks)
