Reducing the Experience of Menopausal Symptoms Through Temperature
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hot Flashes
- Menopause
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 24 peri or postmenopausal women aged 45-60 experiencing at least 4 hot flashes/night sweats/day will use a cooling mattress pad nightly for approximately 8 weeksMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 45 years and 60 years
- Gender
- Only males
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 ...
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.
Tracking Information
- NCT #
- NCT03937466
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nancy E Avis, MD Wake Forest University Health Sciences