Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- PSQI, Sleep Quality
研究概览
简要总结
This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55
- •In second or third trimester of pregnancy (Gestation weeks 18-32)
- •Able to speak, read and write fluent English
- •Has regular access to a smartphone and/or smart tablet
- •sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for ≥3 nights/week, must persist for at least 1 month
排除标准
- •Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period.
- •Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)
结局指标
主要结局
PSQI, Sleep Quality
时间窗: 30 days
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).
Total Wake Time, Sleep Diary
时间窗: 30 days
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.
次要结局
未报告次要终点
研究者
Nalaka Gooneratne
Principal Investigator
University of Pennsylvania