Tobacco UseNCT03276208
Pregnancy, Mindfulness, and Massage
A study testing Prenatal Massage and Mindfulness in people with Tobacco Use and Pregnancy Related, run by Yale University at 1 site in United States.
Trial summary
This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tobacco Use, Pregnancy Related
- What is being tested?
- Prenatal Massage and Mindfulness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- incapable of giving informed consent
- insufficient English fluency
- participating in other smoking cessation programs
- evidencing severe psychiatric symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: 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.
Read the 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.
- Conditions
- Tobacco Use, Pregnancy Related
- Being tested
- Prenatal Massage, Mindfulness
- Keywords
- Pregnancy, Tobacco, Massage Therapy, Mindfulness
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal MassageOther
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.
MindfulnessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Prenatal Massage; Other: Mindfulness |
| 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. Receives: Other: Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco Use Change from Baseline to Post-Intervention
Number of cigarettes smoked in past 24 hours
Measured: Up to 4 weeks
Withdrawal Symptoms Change from Baseline to Post-Intervention
Mood and Physical Symptoms Scale
Measured: Up to 4 weeks
Nicotine Dependence Change from Baseline to Post-Intervention
FTND (Fagerstrom Test for Nicotine Dependence) measure
Measured: Up to 4 weeks
Depression Change from Baseline to Post-Intervention
EPDS (Edinburgh Postnatal Depression Scale) measure
Measured: Up to 4 weeks
Anxiety Change from Baseline to Post-Intervention
Beck Anxiety Inventory
Measured: Up to 4 weeks
Stress Change from Baseline to Post-Intervention
Perceived Stress Scale
Measured: Up to 4 weeks
Daily Stress Scores Change from Baseline to Post-Intervention
Diary Measure
Measured: Up to 4 weeks
Daily Tobacco Usage Change from Baseline to Post-Intervention
Diary Measure
Measured: Up to 4 weeks
Heart Rate Variability Change from Baseline to Post-Intervention
Maternal heart rate variability measured at rest
Measured: Up to 4 weeks
Secondary outcomes (3)
Neonatal Outcomes
mode of delivery (including any complications), infant well-being, gestational age, and weight.
Measured: Up to 2 months
Fetal Heart Rate Change from Baseline to Post-Intervention
Fetal heart rate measured at rest
Measured: Up to 4 weeks
Engagement with Craving to Quit
Engagement with the Craving to Quit app
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start27 Nov 2017
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Why it stopped: Terminated due to lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Massage Therapy Foundation
- Responsible party
- Sponsor
- Investigators
- Helena Rutherford, PhD, Principal investigator, Yale UniversityMichael Paidas, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276208
- Sponsor's protocol ID
- 2000021692
- Status last verified
- Jan 2020
- First submitted
- 20 Aug 2017
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Massage and Mindfulness Study for Tobacco Smoking Women
- ClinicalTrials.gov ID
- NCT03276208
- Acronym / sponsor ID
- 2000021692
- Conditions
- Tobacco Use, Pregnancy Related
- Keywords
- Pregnancy, Tobacco, Massage Therapy, Mindfulness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to lack of enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Massage Therapy Foundation
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will examine the contribution of massage therapy and mindfulness to tobacco-smoking women in the third trimester of pregnancy.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy and Mindfulness | Experimental | Other: Prenatal Massage, Other: MindfulnessParticipants 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. |
| Mindfulness | Active comparator | Other: MindfulnessParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- incapable of giving informed consent
- insufficient English fluency
- participating in other smoking cessation programs
- evidencing severe psychiatric symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal MassageWe 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 | Massage Therapy and Mindfulness |
| MindfulnessThe 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. | Other | Massage Therapy and Mindfulness, Mindfulness |
Primary outcome
Tobacco Use Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Number of cigarettes smoked in past 24 hours
Withdrawal Symptoms Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Mood and Physical Symptoms Scale
Nicotine Dependence Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
FTND (Fagerstrom Test for Nicotine Dependence) measure
Depression Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
EPDS (Edinburgh Postnatal Depression Scale) measure
Anxiety Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Beck Anxiety Inventory
Stress Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Perceived Stress Scale
Daily Stress Scores Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Diary Measure
Daily Tobacco Usage Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Diary Measure
Heart Rate Variability Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Maternal heart rate variability measured at rest
3 secondary outcomes
Neonatal Outcomes
Time frame: Up to 2 months
Fetal Heart Rate Change from Baseline to Post-Intervention
Time frame: Up to 4 weeks
Engagement with Craving to Quit
Time frame: Up to 4 weeks
Results and safety
The study was stopped early (reason given: Terminated due to lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Rutherford, PhD principal investigator
Yale University
Michael Paidas, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal Massage and Mindfulness in people with Tobacco Use and Pregnancy Related, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Terminated due to lack of enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tobacco Use Change from Baseline to Post-Intervention (time frame: Up to 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.