Relaxation Training for Vasomotor Symptoms and Body Awareness in Menopausal and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Menopausal symptoms evaluation scale (MSRS)
研究概览
简要总结
Relaxation training is one of the methods used in the reduction of many menopausal symptoms such as vasomotor symptoms, sleep disturbance, and emotional status changes.
Symptoms seen during menopause; sleep disturbance and lack of body awareness negatively affect women's daily lives. Relaxation exercises play an important role for women to manage this process better. In previous studies, the effects of relaxation training on hot flashes have been investigated, but a comprehensive study including body awareness and sleep problems has not been conducted yet. The aim of this study is to investigate the effect of relaxation training on vasomotor symptoms and body awareness in menopausal and postmenopausal periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being between 50-65 years old,
- •Going through menopause period naturally
- •People who do not receive hormone therapy
排除标准
- •Who entered menopause surgically or medically,
- •With a history of cancer,
- •Who take hormone therapy,
- •With neurological disease,
- •Who use anti-symptom medication.
研究组 & 干预措施
Menopausal period group
24 individuals in the menopausal period
干预措施: Relaxation training (Behavioral)
Postmenopausal period group
24 individuals in the postmenopausal period (patients who have been without a menstrual period for 12 months)
干预措施: Relaxation training (Behavioral)
结局指标
主要结局
Menopausal symptoms evaluation scale (MSRS)
时间窗: 6 weeks
MSRS was developed by Schneider et al (2000) to measure the severity of general menopausal symptoms. The scale consists of 11 items in total and each item is scored between 0 and 4. Scoring was graded as 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score on the scale is 44, and the lowest score is 0. The increase in the scale score indicates the increase in the severity of the complaint.
Pittsburhg sleep quality scale (PSQS)
时间窗: 6 weeks
PSQS is an index that evaluates sleep problems and sleep quality in the last month, consisting of a total of 7 sub-components and 18 problems. These components are subjective sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6) and daytime dysfunction (component 7). Each component is evaluated with a minimum of 0 and a maximum of 3 points. The scale total score is 0 at the lowest and 21 at the highest. According to the scale scoring, a score of 5 and above indicates that sleep quality is low.
Body awareness questionnaire
时间窗: 6 weeks
The body awareness questionnaire is a questionnaire consisting of four subgroups (changes in body process, sleep-wake cycle, estimation at the onset of the disease, estimation of body responses) aiming to determine the normal or abnormal sensitivity level of body composition. It includes 18 questions that measure various aspects of body consciousness, such as the ability to recognize physical sensations, engagement with the body, and awareness of physical condition in different circumstances. Each item is evaluated with a minimum of 1 and a maximum of 7 points. A high score indicates a high level of body awareness.
Body perception scale
时间窗: 6 weeks
Body perception scale is a scale that determines the satisfaction of the person with 40 different body parts or functions. The scale consists of 40 items and each item is scored between 1 and 5 (1 = I like it very much, 2 = I like it a lot, 3 = I am undecided, 4 = I do not like it very much; 5 = I do not like it at all). The total scale score is between 40 and 200. A high scale score indicates a decrease in satisfaction, and a low score indicates an increase in satisfaction.
次要结局
未报告次要终点
研究者
Nihan Ozunlu Pekyavas
PT,PHD,Prof.
Baskent University