Pregnancy, Mindfulness, and Massage

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

Detailed Description
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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.

Official Title
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Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women

Conditions
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Tobacco Use, Pregnancy Related

Intervention / Treatment
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* Other: Prenatal Massage
* Other: Mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage Therapy and Mindfulness<br>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. | Other: Prenatal Massage<br>* 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.<br>Other: Mindfulness<br>* 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.<br>|
| Active Comparator: Mindfulness<br>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. | Other: Mindfulness<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Tobacco, Massage Therapy, Mindfulness