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Terminated due to lack of enrollment.
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| Name | Class |
|---|---|
| Massage Therapy Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Based on biological sex as study of pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Helena Rutherford, PhD | Yale University | Principal Investigator |
| Michael Paidas, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Child Study Center | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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During initial telephone screening participants will be randomized to either intervention or control group
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| 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. |
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| Heart Rate Variability Change from Baseline to Post-Intervention | Maternal heart rate variability measured at rest | Up to 4 weeks |
| Up to 4 weeks |
| Engagement with Craving to Quit | Engagement with the Craving to Quit app | Up to 4 weeks |
| 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 |