Reducing the Experience of Menopausal Symptoms Through Temperature (REST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Hot Flash Diary
研究概览
简要总结
The purposes of this study are to obtain preliminary evidence on the efficacy of a cooling mattress pad in reducing subjective hot flashes for peri and postmenopausal women experiencing menopausal hot flashes, and to obtain preliminary evidence on the efficacy of a cooling mattress pad for improving sleep for peri and postmenopausal women experiencing menopausal hot flashes.
详细描述
Women will be recruited from the community through flyers. They will call into a study phone line at which time they will be screened for their initial eligibility using a telephone screener. Women who are eligible and willing to participate, will either come to the Research Center in Winston-Salem to be consented and complete baseline questionnaires or complete these by mail or email. After two weeks, women will mail back their diaries and continue to record their daily hot flashes until they are notified by study staff of their eligibility, within a week of receiving the diary. If they qualify, a cooling mattress pad will be provided by study staff to be used for the duration of the intervention phase for approximately 8 weeks. The study staff will determine the efficacy of the cooling mattress pad through comparing answers to subject questionnaires at baseline and follow up in addition to comparing the baseline diaries to the intervention diaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 45-60
- •Peri or postmenopausal women (No periods for at least 3 months)
- •Experiencing at least 4 hot flashes per day on average per week
排除标准
- •Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks.
- •Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
- •Initiated antidepressants in the last 3 months.
- •Changed their dose of an antidepressant in the last 3 months.
- •Women who describe their health as fair or poor.
研究组 & 干预措施
Experimental Cooling Mattress Pad
Subjects will use a cooling mattress pad nightly for approximately 8 weeks
干预措施: Cooling mattress pad (Device)
结局指标
主要结局
Hot Flash Diary
时间窗: Week 10
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Hot Flash Severity Index Score
时间窗: Week 10
The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.
Hot Flash Diary
时间窗: baseline
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Hot Flash Severity Index Score
时间窗: baseline
The hot flash severity index score is a weighted total that combines number of hot flashes and severity using a 4- point severity scale from 1= mild to 4= very severe for each hot flash. Severity is calculated by multiplying the number of hot flashes by each level of severity. For example, 5 mild hot flashes would create a score of 5 and 3 very severe hot flashes would have a score of 12.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(Week 10)
- Pittsburgh Sleep Quality Index (PSQI)(baseline)