Pregnancy, Mindfulness, and Massage

Pregnancy Related Clinical Trial

Official title:

Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03276208
• Other study ID #: 2000021692
• Status: Terminated
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: January 24, 2020

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Tobacco Use

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Yale Child Study Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Massage Therapy Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention	breath test	Up to 4 weeks
Other	MINI (Mini International Neuropsychiatric Interview) Substance Dependence	determine other substance use disorders	Enrollment
Other	Self-Reported Mood at each Massage Therapy Session for Intervention Group	positive and negative mood, including stress	Up to 3 weeks
Other	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
Primary	Tobacco Use Change from Baseline to Post-Intervention	Number of cigarettes smoked in past 24 hours	Up to 4 weeks
Primary	Withdrawal Symptoms Change from Baseline to Post-Intervention	Mood and Physical Symptoms Scale	Up to 4 weeks
Primary	Nicotine Dependence Change from Baseline to Post-Intervention	FTND (Fagerstrom Test for Nicotine Dependence) measure	Up to 4 weeks
Primary	Depression Change from Baseline to Post-Intervention	EPDS (Edinburgh Postnatal Depression Scale) measure	Up to 4 weeks
Primary	Anxiety Change from Baseline to Post-Intervention	Beck Anxiety Inventory	Up to 4 weeks
Primary	Stress Change from Baseline to Post-Intervention	Perceived Stress Scale	Up to 4 weeks
Primary	Daily Stress Scores Change from Baseline to Post-Intervention	Diary Measure	Up to 4 weeks
Primary	Daily Tobacco Usage Change from Baseline to Post-Intervention	Diary Measure	Up to 4 weeks
Primary	Heart Rate Variability Change from Baseline to Post-Intervention	Maternal heart rate variability measured at rest	Up to 4 weeks
Secondary	Neonatal Outcomes	mode of delivery (including any complications), infant well-being, gestational age, and weight.	Up to 2 months
Secondary	Fetal Heart Rate Change from Baseline to Post-Intervention	Fetal heart rate measured at rest	Up to 4 weeks
Secondary	Engagement with Craving to Quit	Engagement with the Craving to Quit app	Up to 4 weeks