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临床试验/NCT03783663
NCT03783663已完成不适用

Sleep Self-management in Pregnancy Using a Personalized Health Monitoring Device

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Number of participants that remain in the study for the entire study period for the intervention and control groups.

研究概览

简要总结

Pregnancy-associated sleep disorders are a common acute experience in pregnancy experienced by up to 82% of women. Sleep disorders are associated with increased risk for pre-eclampsia, gestational diabetes, longer labor, cesarean birth, and postpartum depression, and are higher among pregnant women of lower socioeconomic status. Traditional clinical management of sleep disorders in pregnancy includes education and counseling on sleep hygiene and sleep positioning, dietary modifications, relaxation, iron supplementation, weight management, and physical activity, yet education-based behavioral interventions show minimal effectiveness for improving sleep among pregnant women. These methods typically do not incorporate objective self-monitoring, which is an important behavior change technique. In pregnancy, objective self-monitoring on a day-to-day basis is particularly important as sleep disorders may worsen as pregnancy progresses.

Computer-based personalized health monitoring (PHM) devices may serve as an effective tool with which pregnant women can self-manage sleep through incorporation of regular feedback. This strategy may be beneficial not only for women with pregnancy-associated sleep disorders but also for pregnant women with less severe sleep disruptions that experience daytime sleepiness, fatigue, and decreased quality of life. PHM devices have been used to promote weight loss, diet, and physical activity changes but no studies have specifically targeted sleep among pregnant women. The purpose of this pilot study is to establish the feasibility and acceptability of conducting a 12-week intervention for sleep self-management with pregnant women using a PHM device, in order to refine the intervention for a larger, randomized trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • at time of recruitment (t0) women must:
  • be age ≥ 18
  • 14 to <24 completed weeks gestation of pregnancy
  • have no known maternal or fetal complications 3) have a smartphone compatible with the study PHM device 4) have internet access 5) be English speaking 6) be receiving prenatal care.

排除标准

  • pre-existing diabetes mellitus or hypertension
  • diagnosed sleep disorder

研究组 & 干预措施

sleep education only

No Intervention

This arm receives only sleep education from the study nurse.

Sleep education plus Misfit Shine 2

Experimental

This arm receives sleep education from the study nurse and also receives a Misfit Shine 2 to wear for 12 weeks to self-monitor sleep.

干预措施: Misfit Shine 2 (Behavioral)

结局指标

主要结局

Number of participants that remain in the study for the entire study period for the intervention and control groups.

时间窗: 24 to 36 weeks gestation of pregnancy

To assess feasibility of the study, we will calculate the number and percentage of participants in both groups that remain in the study for the entire study period. The study will be considered as feasible if at least 80% of participants remain in the study for its entirety.

Percentage of days during which the Misfit Shine 2 is worn by participants in the intervention group.

时间窗: 24 to 36 weeks gestation of pregnancy

To assess feasibility of the study, for women in the intervention group, we will calculate the proportion of the number of days the Misfit Shine 2 is worn during the study period. We will consider the intervention as feasible if participants wear the Misfit Shine 2 at least 80% of days during the study period.

Participant satisfaction with the sleep education (both groups) and with the Misfit Shine 2 (intervention group only) will be assessed through qualitative interviews.

时间窗: 36 weeks gestation of pregnancy.

At 36 weeks gestation, all participants will be asked to take part in a semi-structured qualitative interview in which open-ended questions will be asked about their sleep patterns, barriers and facilitators of sleep, and whether the sleep education was deemed helpful. Intervention group participants will additionally be asked questions about the experience wearing the MisFit Shine 2, their like and dislikes, and whether they believe it would be helpful to other pregnant women.

次要结局

  • Sleep disturbances as measured by the PROMIS SF v1.0-Sleep Distrubance 6a(24 to 36 weeks gestation of pregnancy)
  • Depressive symptoms as measured by the PROMIS Depression Short Form 6a and the Edinburgh Postnatal Depression Scale(24 to 36 weeks gestation of pregnancy)
  • Sleep quality and duration as measured by the Pittsburgh Sleep Quality Index (PSQI)(24 to 36 weeks gestation of pregnancy)
  • Excessive daytime sleepiness as measured by the Epworth Sleepiness Scale(24 to 36 weeks gestation of pregnancy)
  • Fatigue as measured by the PROMIS Fatigue Short Form 4a(24 to 36 weeks gestation of pregnancy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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