Pregnancy, Mindfulness, and Massage

Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women

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

Study Overview

• Status: Terminated
• Conditions: Tobacco Use; Pregnancy Related
• Intervention / Treatment: Other: Prenatal Massage; Other: Mindfulness

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Massage Therapy and Mindfulness; 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; 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.; Other: Mindfulness; 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.
Active Comparator: Mindfulness; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention	breath test	Up to 4 weeks
MINI (Mini International Neuropsychiatric Interview) Substance Dependence	determine other substance use disorders	Enrollment
Self-Reported Mood at each Massage Therapy Session for Intervention Group	positive and negative mood, including stress	Up to 3 weeks
Mind-mindedness related to infant	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.	Up to 2 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Massage Therapy Foundation
• Investigators: Principal Investigator: Michael Paidas, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: August 20, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Mindfulness; Tobacco; Massage Therapy
• Other Study ID Numbers: 2000021692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No