Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Stress Change from Baseline to Post-Intervention
研究概览
简要总结
This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.
详细描述
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)
盲法说明
During initial telephone screening participants will be randomized to either intervention or control group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •incapable of giving informed consent
- •insufficient English fluency
- •participating in other smoking cessation programs
- •evidencing severe psychiatric symptoms
结局指标
主要结局
Stress Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Perceived Stress Scale
Nicotine Dependence Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
FTND (Fagerstrom Test for Nicotine Dependence) measure
Anxiety Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Beck Anxiety Inventory
Daily Stress Scores Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Diary Measure
Depression Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
EPDS (Edinburgh Postnatal Depression Scale) measure
Heart Rate Variability Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Maternal heart rate variability measured at rest
Withdrawal Symptoms Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Mood and Physical Symptoms Scale
Tobacco Use Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Number of cigarettes smoked in past 24 hours
Daily Tobacco Usage Change from Baseline to Post-Intervention
时间窗: Up to 4 weeks
Diary Measure
次要结局
- Engagement with Craving to Quit(Up to 4 weeks)
- Neonatal Outcomes(Up to 2 months)
- Fetal Heart Rate Change from Baseline to Post-Intervention(Up to 4 weeks)