N/A
Completed N=38
Reducing the Experience of Menopausal Symptoms Through Temperature
Hot Flashes · Menopause
Source: ClinicalTrials.gov NCT03937466 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Hot Flash Diary — 9 number of hot flashes per week
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hot Flash Diary |
4.5 | — |
| PRIMARY Hot Flash Severity Index Score |
7.8 | — |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
7.87 | — |
Eligibility Criteria
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
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.
Data sourced from ClinicalTrials.gov (NCT03937466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.