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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03276208
Other study ID # 2000021692
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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