Clinical trial NCT03276208: Pregnancy, Mindfulness, and Massage
Official title: Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tobacco Use
Pregnancy Related
Keywords: Pregnancy
Tobacco
Massage Therapy
Mindfulness
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Massage Therapy Foundation
First posted: 2017-09-08
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tobacco Use Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Withdrawal Symptoms Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Nicotine Dependence Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Depression Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Anxiety Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Stress Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Daily Stress Scores Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Daily Tobacco Usage Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Heart Rate Variability Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Neonatal Outcomes
timeFrame: Up to 2 months
measure: Fetal Heart Rate Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: Engagement with Craving to Quit
timeFrame: Up to 4 weeks
Other outcomes:
measure: CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
timeFrame: Up to 4 weeks
measure: MINI (Mini International Neuropsychiatric Interview) Substance Dependence
timeFrame: Enrollment
measure: Self-Reported Mood at each Massage Therapy Session for Intervention Group
timeFrame: Up to 3 weeks
measure: Mind-mindedness related to infant
timeFrame: Up to 2 months
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Helena Rutherford, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Michael Paidas, MD
role: PRINCIPAL_INVESTIGATOR
References: