Pregnancy, Mindfulness, and Massage
2020年1月27日 更新者：Yale University
Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women
This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.
研究概览
详细说明
Massage therapy may be a viable approach to decrease stress during pregnancy that may in turn reduce tobacco consumption.
Massage therapy may not be sufficient as a stand-alone approach, and may be better suited partnered with a cessation approach that targets another mechanism of addiction, craving.
Therefore, participants (N=60) will be enrolled in the Craving to Quit® tobacco cessation program, designed by researchers at Yale, which employs a mindfulness-based approach to train participants to recognize and bring cravings into their conscious awareness.
Each mother will be randomly assigned to a bi-weekly massage intervention (n=30) or control (n=30) group.
Participants in the intervention group will receive two prenatal massages a week for a three-week period.
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale Child Study Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- currently pregnant in third trimester
- singleton pregnancy
- aged 18 years or older
- women smoked before their pregnancy
- women who currently smoke at least 5 cigarettes per day at enrollment
- women need access to a smartphone
- women expressing an interest in learning skills to help decrease tobacco-smoking
Exclusion Criteria:
- incapable of giving informed consent
- insufficient English fluency
- participating in other smoking cessation programs
- evidencing severe psychiatric symptoms
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Massage Therapy and Mindfulness
Participants in the intervention group will receive two prenatal massages a week for a three-week period.
They will also be enrolled in the mindfulness-based Craving to Quit® tobacco cessation program during this 3-week period.
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We will utilize moderate pressure Swedish massage (SM) that utilizes long slow strokes known as effleurage and kneading strokes known as petrissage.
A specific routine will be performed on each participant with focus on low back, upper back, shoulders, and neck musculature.
Consistent moderate pressure, which is lighter than deep tissue massage but deeper than brush strokes, will be used.
The intervention and control group will be enrolled in the Craving to Quit® program, a 21-day mindfulness-based program delivered via a smartphone application (https://www.cravingtoquit.com/).
This program uses a mindfulness-based approach to train people to recognize and be aware of their tobacco cravings.
The program includes videos, online exercises to complete, and a virtual support community.
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有源比较器：Mindfulness
Participants will enroll in the mindfulness-based Craving to Quit® tobacco cessation program during the same 3-week period.
A massage will be provided upon completion of the study.
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The intervention and control group will be enrolled in the Craving to Quit® program, a 21-day mindfulness-based program delivered via a smartphone application (https://www.cravingtoquit.com/).
This program uses a mindfulness-based approach to train people to recognize and be aware of their tobacco cravings.
The program includes videos, online exercises to complete, and a virtual support community.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tobacco Use Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Number of cigarettes smoked in past 24 hours
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Up to 4 weeks
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Withdrawal Symptoms Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Mood and Physical Symptoms Scale
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Up to 4 weeks
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Nicotine Dependence Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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FTND (Fagerstrom Test for Nicotine Dependence) measure
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Up to 4 weeks
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Depression Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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EPDS (Edinburgh Postnatal Depression Scale) measure
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Up to 4 weeks
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Anxiety Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Beck Anxiety Inventory
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Up to 4 weeks
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Stress Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Perceived Stress Scale
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Up to 4 weeks
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Daily Stress Scores Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Diary Measure
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Up to 4 weeks
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Daily Tobacco Usage Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Diary Measure
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Up to 4 weeks
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Heart Rate Variability Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Maternal heart rate variability measured at rest
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Up to 4 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Neonatal Outcomes
大体时间：Up to 2 months
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mode of delivery (including any complications), infant well-being, gestational age, and weight.
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Up to 2 months
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Fetal Heart Rate Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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Fetal heart rate measured at rest
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Up to 4 weeks
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Engagement with Craving to Quit
大体时间：Up to 4 weeks
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Engagement with the Craving to Quit app
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Up to 4 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
大体时间：Up to 4 weeks
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breath test
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Up to 4 weeks
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MINI (Mini International Neuropsychiatric Interview) Substance Dependence
大体时间：Enrollment
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determine other substance use disorders
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Enrollment
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Self-Reported Mood at each Massage Therapy Session for Intervention Group
大体时间：Up to 3 weeks
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positive and negative mood, including stress
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Up to 3 weeks
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Mind-mindedness related to infant
大体时间：Up to 2 months
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Describe your child measure; this will be a narrative statement provided by participants where they are asked to describe their child.
These narratives will be scored to ascertain the total number of mind-minded comments included in the narrative.
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Up to 2 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月27日
初级完成 (实际的)
2020年1月24日
研究完成 (实际的)
2020年1月24日
研究注册日期
首次提交
2017年8月20日
首先提交符合 QC 标准的
2017年9月6日
首次发布 (实际的)
2017年9月8日
研究记录更新
最后更新发布 (实际的)
2020年1月29日
上次提交的符合 QC 标准的更新
2020年1月27日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.