Pregnancy, Mindfulness, and Massage

NCT03276208 | Terminated

• 1 other identifier: 2000021692
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use; Pregnancy Related

Keywords

Pregnancy; Tobacco; Massage Therapy; Mindfulness

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Neonatal Outcomes

  Up to 2 months

• Fetal Heart Rate Change from Baseline to Post-Intervention

  Up to 4 weeks

• Engagement with Craving to Quit

  Up to 4 weeks

Other Outcomes (4)

• CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention

  Up to 4 weeks

• MINI (Mini International Neuropsychiatric Interview) Substance Dependence

  Enrollment

• Self-Reported Mood at each Massage Therapy Session for Intervention Group

  Up to 3 weeks

Study Arms (2)

Massage Therapy and Mindfulness

EXPERIMENTAL

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; Other: Mindfulness

Mindfulness

ACTIVE COMPARATOR

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

Interventions

Prenatal Massage OTHER

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.

Massage Therapy and Mindfulness

Mindfulness OTHER

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.

Massage Therapy and Mindfulness; Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Based on biological sex as study of pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• incapable of giving informed consent
• insufficient English fluency
• participating in other smoking cessation programs
• evidencing severe psychiatric symptoms

Sponsors & Collaborators

• Yale University: lead
• Massage Therapy Foundation: collaborator

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Helena Rutherford, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Michael Paidas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During initial telephone screening participants will be randomized to either intervention or control group
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: September 8, 2017
• Study Start: November 27, 2017
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)