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Reducing the Experience of Menopausal Symptoms Through Temperature
NA trial testing Cooling mattress pad in Hot Flashes in 38 participants. Completed in 4 June 2021.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 38 |
| Start date | 30 July 2019 |
| Primary completion | 4 June 2021 |
| Estimated completion | 4 June 2021 |
| Sites | 1 location across United States |
Wake Forest University Health Sciences
Adults 45 to 60, female only, with Hot Flashes or Menopause. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 9 | ± 4.5 |
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 4.5 | ± 3.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 20.0 | ± 10.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 7.8 | ± 6.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 11.14 | ± 3.16 |
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
| Group | Value | 95% CI |
|---|---|---|
| Experimental Cooling Mattress Pad | 7.87 | ± 3.50 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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