An interventional study of Prenatal Massage and Mindfulness in Tobacco Use and Pregnancy Related, sponsored by Yale University. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Yale University · Not applicable, Interventional, and Other
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Among 311 studies in Tobacco Use with a site in United States — 52 open to participants now, 63 under way, 1 of them phase 3. Tobacco Use · United States.
Among the 311 studies in Tobacco Use with a site in United States, this one is the 270th largest by enrollment of the 286 interventional ones that give a count, is one of 21 that started in 2017, is one of 231 with no phase, and was the 94th registered.
421 studies on the registry are indexed under Tobacco Use; 83 are open to participants now.
Browse Tobacco Use studies →52 of the 311 studies in Tobacco Use with a site in United States are open now. Recruiting first, the newest first:
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pennsylvania · Sites in United States
Ages 18+
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
University of Pittsburgh · Sites in United States
Ages 18+ · Women only
RAI Services Company · Sites in United States
Ages 21–65 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 50 Tobacco Use studies recruiting now, 28 (56%) set no upper age limit and 18 (36%) stop at 75 or younger; 2 take children under 18; 27 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
311 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 22 · Phase 3 10 · Phase 4 9
First in 1992; this study’s year is marked. 21 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 127 across 352 interventional studies indexed under Tobacco Use.
Median enrollment 120 across the 286 interventional studies, 174 across the 24 observational. Of the 232 that completed or were terminated, 82 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
67 of 311 have an industry lead sponsor. The 10 most frequent:
Yale University is the lead sponsor of 1,771 studies on the registry; 295 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Yale University has 7 studies filed under Tobacco Use — fewer than ten, so there is no comparison to draw.
30 of the studies in Tobacco Use with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707871Wake Forest University Health SciencesCardiovascular Effects of Very Low Nicotine Content Cigarettes | 2026-12 |
| NCT07710820RAI Services CompanyA Multi-Site Study to Assess the Effect of Availability of a Heated Tobacco Product on Smoking Abstinence Among Current Primary Cigarette Smokers | 2026-12 |
| NCT05445804Johns Hopkins UniversityOral Cannabidiol for Tobacco Cessation | 2026-12-01 |
| NCT07598136RAI Services CompanyA Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers | 2026-12-17 |
| NCT04297592Mayo ClinicAntibiotic Prophylaxis in High-Risk Arthroplasty Patients | 2027-01 |
Add all 30 to your calendar (.ics) → With an account.
Among the 311 studies in Tobacco Use with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
Tobacco Use Change from Baseline to Post-Intervention
Number of cigarettes smoked in past 24 hours
Time frame: Up to 4 weeks
Withdrawal Symptoms Change from Baseline to Post-Intervention
Mood and Physical Symptoms Scale
Time frame: Up to 4 weeks
Nicotine Dependence Change from Baseline to Post-Intervention
FTND (Fagerstrom Test for Nicotine Dependence) measure
Time frame: Up to 4 weeks
Depression Change from Baseline to Post-Intervention
EPDS (Edinburgh Postnatal Depression Scale) measure
Time frame: Up to 4 weeks
Anxiety Change from Baseline to Post-Intervention
Beck Anxiety Inventory
Time frame: Up to 4 weeks
Stress Change from Baseline to Post-Intervention
Perceived Stress Scale
Time frame: Up to 4 weeks
Daily Stress Scores Change from Baseline to Post-Intervention
Diary Measure
Time frame: Up to 4 weeks
Daily Tobacco Usage Change from Baseline to Post-Intervention
Diary Measure
Time frame: Up to 4 weeks
Heart Rate Variability Change from Baseline to Post-Intervention
Maternal heart rate variability measured at rest
Time frame: Up to 4 weeks
Neonatal Outcomes
mode of delivery (including any complications), infant well-being, gestational age, and weight.
Time frame: Up to 2 months
Fetal Heart Rate Change from Baseline to Post-Intervention
Fetal heart rate measured at rest
Time frame: Up to 4 weeks
Engagement with Craving to Quit
Engagement with the Craving to Quit app
Time frame: Up to 4 weeks
CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
breath test
Time frame: Up to 4 weeks
MINI (Mini International Neuropsychiatric Interview) Substance Dependence
determine other substance use disorders
Time frame: Enrollment
Self-Reported Mood at each Massage Therapy Session for Intervention Group
positive and negative mood, including stress
Time frame: 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.
Time frame: Up to 2 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jan 2020, 25 months.
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This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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