Reducing the Experience of Menopausal Symptoms Through Temperature

Not Applicable

Completed

• Conditions: Hot Flashes; Menopause
• Interventions: Device: Cooling mattress pad

• Registration Number: NCT03937466
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-03
• Study Start: 2019-07-30
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Results First Submitted: 2022-05-27
• Status Verified: 2022-06
• Results First Submitted QC: 2022-06-27
• Last Update Submitted: 2022-06-27
• Results First Posted: 2022-06-29
• Last Update Posted: 2022-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Cooling Mattress Pad	Cooling mattress pad	Subjects will use a cooling mattress pad nightly for approximately 8 weeks

Primary Outcome Measures

Name	Time	Method
Hot Flash Diary	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	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.

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	Week 10	Questionnaire that assesses the subjects' quality of sleep through their answers to 19 questions on sleep quality. The global score ranges from 0 to 16 with a score \>5 indicating poor sleep quality

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States