Pregnancy, Mindfulness, and Massage

Not Applicable

Terminated

• Conditions: Pregnancy Related; Tobacco Use

• Registration Number: NCT03276208
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Study Start: 2017-11-27
• Status Verified: 2020-01
• Primary Completion: 2020-01-24
• Study Completion: 2020-01-24
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

Trial Locations

Locations (1)

Yale Child Study Center; 🇺🇸 New Haven, Connecticut, United States