The Effect of Guided Imagery on Quality of Life and Insomnia in Perimenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The study will be conducted in two groups as guided imagery and control. Participants will be approached at the Public Education Center. After perimenopausal women are evaluated according to eligibility criteria, those who are eligible will be informed about the research and written informed consent will be obtained from those who agree. Random assignment of women to the study groups will be carried out using randomization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being between 45-59 years of age
- •Being in the perimenopausal period according to the Stages of Reproductive Aging Workshop (STRAW) criteria (stage +1 or +2)
- •Early menopausal transition (STRAW -2): menstrual cycle length varies by 7 days or more
- •Late menopausal transition (STRAW -1): amenorrhea lasting 60 days or longer
- •Having entered natural menopause in postmenopausal women
- •Scoring above 10 on the Women's Health Initiative Insomnia Rating Scale
- •Owning a smartphone
- •Ability to understand and speak Turkish
- •No hearing impairment
- •Volunteering to participate in the study
排除标准
- •Having received or currently receiving hormone replacement therapy
- •Alcohol use
- •Practicing another mind-body intervention
- •Having a diagnosed disease that may cause sleep disorders and receiving medical treatment
- •Having a diagnosed disease that may significantly affect quality of life and receiving medical treatment
研究组 & 干预措施
Guided imagery
干预措施: Guided imagery (Other)
Control
结局指标
主要结局
Change in Quality of Life
时间窗: at the beginning of the study, 4 weeks and 8 weeks later
The Menopause-Specific Quality of Life Questionnaire-II (MENQOL-II) is a 29-item Likert-type scale used to assess the presence and severity of menopausal symptoms in women aged 45-59, including premenopausal, perimenopausal, postmenopausal, and surgical menopause. The scale has four subdomains: vasomotor, psychosocial, physical, and sexual. Each item is scored from 1 to 8, yielding a total score range between 29 and 232. Higher scores indicate a greater negative impact of menopausal symptoms on quality of life.
Change in Insomnia
时间窗: at the beginning of the study, 4 weeks and 8 weeks later
The Women's Health Initiative Insomnia Rating Scale (WHIIRS) is a 5-item Likert-type scale used to evaluate insomnia symptoms, including sleep onset, sleep maintenance, early awakening, and sleep quality. Each item is scored between 0 and 4, with a total score ranging from 0 to 20. Higher scores indicate greater severity of insomnia
次要结局
未报告次要终点
研究者
Menekşe Nazlı AKER
Assist. Prof.
Ankara University