Pregnancy, Mindfulness, and Massage

Not Applicable

Terminated

Brief Summary: This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Massage Therapy and Mindfulness	Prenatal Massage	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.
Massage Therapy and Mindfulness	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.
Mindfulness	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.

Primary Outcome Measures

Name	Time	Method
Nicotine Dependence Change from Baseline to Post-Intervention	Up to 4 weeks	FTND (Fagerstrom Test for Nicotine Dependence) measure
Anxiety Change from Baseline to Post-Intervention	Up to 4 weeks	Beck Anxiety Inventory
Daily Stress Scores Change from Baseline to Post-Intervention	Up to 4 weeks	Diary Measure
Depression Change from Baseline to Post-Intervention	Up to 4 weeks	EPDS (Edinburgh Postnatal Depression Scale) measure
Stress Change from Baseline to Post-Intervention	Up to 4 weeks	Perceived Stress Scale
Heart Rate Variability Change from Baseline to Post-Intervention	Up to 4 weeks	Maternal heart rate variability measured at rest
Withdrawal Symptoms Change from Baseline to Post-Intervention	Up to 4 weeks	Mood and Physical Symptoms Scale
Tobacco Use Change from Baseline to Post-Intervention	Up to 4 weeks	Number of cigarettes smoked in past 24 hours
Daily Tobacco Usage Change from Baseline to Post-Intervention	Up to 4 weeks	Diary Measure

Secondary Outcome Measures

Name	Time	Method
Engagement with Craving to Quit	Up to 4 weeks	Engagement with the Craving to Quit app
Neonatal Outcomes	Up to 2 months	mode of delivery (including any complications), infant well-being, gestational age, and weight.
Fetal Heart Rate Change from Baseline to Post-Intervention	Up to 4 weeks	Fetal heart rate measured at rest

Locations (1): Yale Child Study Center
🇺🇸
New Haven, Connecticut, United States