Pregnancy, Mindfulness, and Massage

Yale University

Status: Terminated

Conditions: Pregnancy Related; Tobacco Use

Treatments: Other: Mindfulness; Other: Prenatal Massage

Study type: Interventional

Funder types: Other

Identifiers

NCT03276208

2000021692

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Massage Therapy and Mindfulness

Experimental group

Description:

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.

Treatment:

Other: Mindfulness

Other: Prenatal Massage

Mindfulness

Active Comparator group

Description:

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.

Treatment:

Other: Mindfulness