This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
12
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.
Yale Child Study Center
New Haven, Connecticut, United States
Tobacco Use Change from Baseline to Post-Intervention
Number of cigarettes smoked in past 24 hours
Time frame: Up to 4 weeks
Withdrawal Symptoms Change from Baseline to Post-Intervention
Mood and Physical Symptoms Scale
Time frame: Up to 4 weeks
Nicotine Dependence Change from Baseline to Post-Intervention
FTND (Fagerstrom Test for Nicotine Dependence) measure
Time frame: Up to 4 weeks
Depression Change from Baseline to Post-Intervention
EPDS (Edinburgh Postnatal Depression Scale) measure
Time frame: Up to 4 weeks
Anxiety Change from Baseline to Post-Intervention
Beck Anxiety Inventory
Time frame: Up to 4 weeks
Stress Change from Baseline to Post-Intervention
Perceived Stress Scale
Time frame: Up to 4 weeks
Daily Stress Scores Change from Baseline to Post-Intervention
Diary Measure
Time frame: Up to 4 weeks
Daily Tobacco Usage Change from Baseline to Post-Intervention
Diary Measure
Time frame: Up to 4 weeks
Heart Rate Variability Change from Baseline to Post-Intervention
Maternal heart rate variability measured at rest
Time frame: Up to 4 weeks
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Neonatal Outcomes
mode of delivery (including any complications), infant well-being, gestational age, and weight.
Time frame: Up to 2 months
Fetal Heart Rate Change from Baseline to Post-Intervention
Fetal heart rate measured at rest
Time frame: Up to 4 weeks
Engagement with Craving to Quit
Engagement with the Craving to Quit app
Time frame: Up to 4 weeks