Hot Flashes, Menopause
Conditions
Keywords
hot flashes, menopause, cooling mattress pad
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.
Interventions
DEVICECooling mattress pad
The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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 weeks
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hot Flash Diary | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Studies Depression Scale (CESD-10) | baseline | Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better. |
| Health Related Quality of Life (HRQL) | baseline | Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better. |
| Somatosensory Amplification Scale (SSAS) | baseline | Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better. |
| General Anxiety Disorder (GAD-7) | baseline and week 11 | Anxiety symptoms will be measured with the GAD-7, which consists of 7 items, each describing a common symptom of anxiety. The respondent rates how much he or she has been bothered by each symptom over the past two weeks on a 4-point scale ranging from 0 to 3. Higher scores indicate more anxiety. |
| Health Behaviors Questionnaire | baseline | Questionnaire that allows the study team to record baseline behaviors |
| Evaluation of Intervention | follow up at 11 weeks | Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked. |
| Hot Flash Related Daily Interference Scale (HFRDIS) | baseline | Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Cooling Mattress Pad Subjects will use a cooling mattress pad nightly for approximately 8 weeks
Cooling mattress pad: The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 3 did not complete follow-up questionnaire. | 3 |
| Overall Study | dropped out of study before getting Chilipad | 5 |
| Overall Study | never returned their diary | 6 |
| Overall Study | not eligbile after the 2-week diary | 9 |
Baseline characteristics
| Characteristic | Experimental Cooling Mattress Pad |
|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Hot Flash Diary
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Hot Flash Diary | 9 number of hot flashes per week | Standard Deviation 4.5 |
Primary
Hot Flash Diary
Daily diary in which subjects will record the number of daily hot flashes and/or night sweats; reported as mean weekly number.
Time frame: Week 10
Population: 4 participants did not fill out hot flash diary at week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Hot Flash Diary | 4.5 number of hot flashes per week | Standard Deviation 3 |
Primary
Hot Flash Severity Index Score
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Hot Flash Severity Index Score | 20.0 score on a scale | Standard Deviation 10.4 |
Primary
Hot Flash Severity Index Score
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.
Time frame: Week 10
Population: 4 did not fill out hot flash diaries at week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Hot Flash Severity Index Score | 7.8 score on a scale | Standard Deviation 6.4 |
Secondary
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame: baseline
Population: 1 person did not answer all PSQI items at baseline, so data not included here.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Pittsburgh Sleep Quality Index (PSQI) | 11.14 score on a scale | Standard Deviation 3.16 |
Secondary
Pittsburgh Sleep Quality Index (PSQI)
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
Time frame: Week 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental Cooling Mattress Pad | Pittsburgh Sleep Quality Index (PSQI) | 7.87 score on a scale | Standard Deviation 3.5 |
Other Pre-specified
Center for Epidemiologic Studies Depression Scale (CESD-10)
Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.
Time frame: baseline
Other Pre-specified
Center for Epidemiologic Studies Depression Scale (CESD-10)
Questionnaire that assesses depression level (or lack of) in subjects. Scores range from 0-3 with a lower score being better.
Time frame: follow up at 11 weeks
Other Pre-specified
Evaluation of Intervention
Questionnaire that allows the study team to evaluate the subject's perception of how well the intervention worked.
Time frame: follow up at 11 weeks
Other Pre-specified
General Anxiety Disorder (GAD-7)
Anxiety symptoms will be measured with the GAD-7, which consists of 7 items, each describing a common symptom of anxiety. The respondent rates how much he or she has been bothered by each symptom over the past two weeks on a 4-point scale ranging from 0 to 3. Higher scores indicate more anxiety.
Time frame: baseline and week 11
Other Pre-specified
Health Behaviors Questionnaire
Questionnaire that allows the study team to record baseline behaviors
Time frame: baseline
Other Pre-specified
Health Related Quality of Life (HRQL)
Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.
Time frame: follow up at 11 weeks
Other Pre-specified
Health Related Quality of Life (HRQL)
Questionnaire that assesses quality of life in subjects. Score range 0-100 with a higher score being better.
Time frame: baseline
Other Pre-specified
Hot Flash Related Daily Interference Scale (HFRDIS)
Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.
Time frame: baseline
Other Pre-specified
Hot Flash Related Daily Interference Scale (HFRDIS)
Questionnaire that assesses interference that hot flashes cause in subjects' daily life. Scores range from 0-10 with a lower score being better.
Time frame: follow up at 11 weeks
Other Pre-specified
Somatosensory Amplification Scale (SSAS)
Questionnaire that assesses subject symptom sensitivity. Scores range 10-50 with a lower score being better.
Time frame: baseline