The Effects of Reiki on Menopausal Symptoms and Depression Levels in the Postmenopausal Period: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
Objective: This study was conducted to determine the effects of Reiki applied to women in the postmenopausal period on menopausal symptoms and depression levels.
Methodology:This randomized controlled study was conducted with postmenopausal women registered in a family health center in eastern Türkiye. The sample of the study consisted of 82 women, 41 in the Reiki group and 41 in the control group. While four sessions of Reiki were applied to the women in the Reiki group, once a week for 4 weeks, no intervention was applied to the control group. Menopause Rating Scale (MRS) and Beck Depression Inventory (BDI) were used to collect data.
详细描述
Design This study was designed as a randomized controlled trial in which participants were randomly assigned to Reiki or control groups.
Location and time The study was conducted with postmenopausal women registered at a Family Health Center (FHC) located in the center of a province in eastern Türkiye between May 2023 and July 2023. The center is a primary healthcare institution that provides general healthcare services and reproductive healthcare services (such as family planning, education, and counseling). There is no application specific to the menopausal period in the center. This center was randomly selected considering its socioeconomic level, proximity to the city center, and the number of women registered in the center. The center serves approximately 15.000 individuals, of which approximately 5100 are women. In addition, there was a quiet and calm hall in the center where Reiki could be practiced.
Population and sample of the study The population of the study consisted of postmenopausal women registered to the determined FHC. Women who applied to the FHC for any reason, agreed to participate voluntarily, and met the inclusion criteria were included in the study. The criteria for inclusion in the study were as follows: Those who were between the ages of 45-55, did not have hearing problems, did not have any psychiatric diseases, were in a natural menopause period, and did not take hormone replacement therapy.
A web-based software was used to determine the sample size. Priori-power analysis was performed to estimate the appropriate sample size. In the literature, the mean score of menopausal symptoms, which is the primary result of the study, was found to be 16.6 (standard deviation 8.9). The sample size was calculated as 41 for each group (41 Reiki group, 41 control group), assuming a 5% error level, bidirectional significance level, 95% confidence interval, 80% representation of the population, and assuming to create a decrease in the post-intervention menopausal symptoms mean score by 5 points.
To reach the sample size, 140 women were evaluated in terms of eligibility criteria. 47 women who did not meet the inclusion criteria and 19 women who refused to participate in the study were excluded from the study. 7 out of 50 women included in the Reiki group were excluded from the study because they did not continue the sessions after the second Reiki session. Seven of the 53 women included in the control group were excluded from the study because they did not want to continue the study. The research was completed with a total of 82 women, 41 of them in the Reiki group and 41 of them in 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
- 45 Years 至 55 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •who were between the ages of 45-55,
- •did not have hearing problems,
- •did not have any psychiatric diseases,
- •were in a natural menopause period,
- •did not take hormone replacement therapy.
排除标准
- •having a diagnosis of any psychiatric illness
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: Change from menopause symptoms levels at 4 weeks
The Menopause Rating Scale (MRS) assess the severity of menopausal symptoms. The scale consists of 11 items and 3 subscales. These 3 subscales are called somato-vegetative complaints (such as night sweating and hot flush), psychological complaints (such as anxiety and depression), and urogenital complaints (such as urethral syndrome and vaginal dryness). The scale is in the form of a 5-point Likert type and each item is graded between zero (no complaints) and four (severe symptoms) points. The total score that can be obtained from the scale varies between 0-44 points. An increase in the total score obtained from the scale indicates that the menopausal complaints experienced are intensified.
次要结局
- Beck Depression Inventory (BDI)(Change from depression levels at 4 weeks)
研究者
Esra SABANCI BARANSEL
Assit. Prof
Inonu University
