Pregnancy Related, Tobacco Use
Conditions
Keywords
Pregnancy, Tobacco, Massage Therapy, Mindfulness
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.
Interventions
OTHERPrenatal Massage
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.
OTHERMindfulness
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.
Sponsors
Massage Therapy Foundation
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
During initial telephone screening participants will be randomized to either intervention or control group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Nicotine Dependence Change from Baseline to Post-Intervention | Up to 4 weeks | FTND (Fagerstrom Test for Nicotine Dependence) measure |
| Depression Change from Baseline to Post-Intervention | Up to 4 weeks | EPDS (Edinburgh Postnatal Depression Scale) measure |
| Anxiety Change from Baseline to Post-Intervention | Up to 4 weeks | Beck Anxiety Inventory |
| Stress Change from Baseline to Post-Intervention | Up to 4 weeks | Perceived Stress Scale |
| Daily Stress Scores Change from Baseline to Post-Intervention | Up to 4 weeks | Diary Measure |
| Daily Tobacco Usage Change from Baseline to Post-Intervention | Up to 4 weeks | Diary Measure |
| Tobacco Use Change from Baseline to Post-Intervention | Up to 4 weeks | Number of cigarettes smoked in past 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Engagement with Craving to Quit | Up to 4 weeks | Engagement with the Craving to Quit app |
Other
| Measure | Time frame | Description |
|---|---|---|
| MINI (Mini International Neuropsychiatric Interview) Substance Dependence | Enrollment | determine other substance use disorders |
| CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention | Up to 4 weeks | breath test |
| Self-Reported Mood at each Massage Therapy Session for Intervention Group | Up to 3 weeks | positive and negative mood, including stress |
| Mind-mindedness related to infant | Up to 2 months | Describe your child measure; this will be a narrative statement provided by participants where they are asked to describe their child. These narratives will be scored to ascertain the total number of mind-minded comments included in the narrative. |
Countries
United States
Outcome results
None listed