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This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women
This is a randomized, 60-day research study that is evaluating the effect of a simplified behavioral relaxation intervention in pregnant and postpartum patients aimed to improve their insomnia symptoms. The investigators will be enrolling a total of 20 patients who indicate self-reported insomnia symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Hygiene | Active Comparator | This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding |
|
| ART and Sleep Hygiene | Experimental | This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assisted Therapy | Behavioral | The participant will receive coaching calls and support |
|
| Measure | Description | Time Frame |
|---|---|---|
| PSQI, Sleep Quality | Measured by a single item score, sleep quality is the measurement of how restful and restorative the sleep of an individual is. Pittsburgh Sleep Quality Index: Well- known questionnaire used to measure sleep quality in various patient groups. For overall sleep quality, the minimum score= 0 (better) and the maximum score=3 (worse). | 30 days |
| Total Wake Time, Sleep Diary | A sleep diary will be used to gather information about the participants daily sleep pattern and schedule; gold standard of care for insomnia. This instrument will also be used to check adherence to the Gratification practice of the ART intervention. This will be administered during pre-screening and intervention. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalaka Gooneratne, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Sleep Hygiene | Behavioral | Standard Sleep Hygiene instructions. |
|
| D001523 |
| Mental Disorders |