CALM Pregnancy: Feasibility of Mindfulness-based Prenatal Stress Reduction Using a Smart Phone Meditation Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Feasibility: Demand (Time spent in meditation and meditations used)
研究概览
简要总结
The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth).
Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey.
Demand will be measured using time spent in meditation and meditations used (tracked by Calm).
For the intervention group, the benchmarks will be as follows:
- Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction,
- Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm.
Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation.
Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).
详细描述
Enrollment: Interested participants at Valley Perinatal Clinics will be asked for their email and will be sent a link to a brief (5-10 minute) eligibility screener via RedCap (See Eligibility screener). Eligible participants will be asked to watch a brief intake video followed by a 3-question quiz and asked to sign an electronic informed consent prior to completing any further surveys. After informed consents have been completed, participants (N=97) will be identified. Participants will be asked to complete a baseline questionnaire (See Surveys and Questionnaires document) and complete a medical history form, which will ask participants to include a history of medications. They also will be asked to sign a medical release form for their obstetrician. Ineligible participants will be notified by email according to the script (See Email Scripts document).
Randomization: Participants will be randomized into either the intervention (Calm App) or standard prenatal care control and given further instructions to begin participating (See Welcome Email in Email Scripts document).
Inclusion criteria are: (1) women 12-16 weeks pregnant, (2) >18 years of age, (3) English speaking, (3) not currently on steroid therapy, (4) willing to download the Calm app to their smartphone, and (5) have not practiced meditation or mindful movement more than 60 minutes a month in the past six months (6) willing to be randomized to one of two groups.
Control: The control group will be asked to maintain normal activity and refrain from using Calm meditation app.
Intervention: Participants (n=49) will be provided free access to and asked to register for the consumer-based mobile meditation app on their phone. Participants (n=49) will then receive an email containing 28 weeks of free access to Calm. Participants (n=49) will be asked to use Calm at least 10 minutes per day and encouraged to use it as much as they would like during the intervention. This prescription mimics how a new, paying member would use the app (full exposure with autonomy).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women 12-16 weeks pregnant
- •18 years of age
- •English speaking
- •not currently on steroid therapy
- •willing to download the Calm app to their smartphone,
- •have not practiced meditation or mindful movement more than 60 minutes a month in the past six months
- •willing to be randomized to one of two groups.
排除标准
- 未提供
结局指标
主要结局
Feasibility: Demand (Time spent in meditation and meditations used)
时间窗: At birth/delivery
Demand will be gathered using meditation app usage data and defined as at least 70% of intervention group will adhere to at 75% of prescribed meditation
Feasibility: Acceptability
时间窗: Two weeks after delivery of baby
Acceptability will be measured with an investigator developed survey
次要结局
- Perceived Stress of Participant(baseline, 16, 20, 24, 28, 32, and 36 weeks' gestation, two weeks after delivery of baby)