Pregnancy, Mindfulness, and Massage
2020年1月27日 更新者：Yale University
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
12
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06520
- Yale Child Study Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Massage Therapy and Mindfulness
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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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.
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アクティブコンパレータ：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.
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tobacco Use Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Number of cigarettes smoked in past 24 hours
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Up to 4 weeks
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Withdrawal Symptoms Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Mood and Physical Symptoms Scale
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Up to 4 weeks
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Nicotine Dependence Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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FTND (Fagerstrom Test for Nicotine Dependence) measure
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Up to 4 weeks
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Depression Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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EPDS (Edinburgh Postnatal Depression Scale) measure
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Up to 4 weeks
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Anxiety Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Beck Anxiety Inventory
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Up to 4 weeks
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Stress Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Perceived Stress Scale
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Up to 4 weeks
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Daily Stress Scores Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Diary Measure
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Up to 4 weeks
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Daily Tobacco Usage Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Diary Measure
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Up to 4 weeks
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Heart Rate Variability Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Maternal heart rate variability measured at rest
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Up to 4 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neonatal Outcomes
時間枠：Up to 2 months
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mode of delivery (including any complications), infant well-being, gestational age, and weight.
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Up to 2 months
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Fetal Heart Rate Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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Fetal heart rate measured at rest
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Up to 4 weeks
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Engagement with Craving to Quit
時間枠：Up to 4 weeks
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Engagement with the Craving to Quit app
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Up to 4 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
時間枠：Up to 4 weeks
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breath test
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Up to 4 weeks
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MINI (Mini International Neuropsychiatric Interview) Substance Dependence
時間枠：Enrollment
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determine other substance use disorders
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Enrollment
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Self-Reported Mood at each Massage Therapy Session for Intervention Group
時間枠：Up to 3 weeks
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positive and negative mood, including stress
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Up to 3 weeks
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Mind-mindedness related to infant
時間枠：Up to 2 months
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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.
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Up to 2 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年11月27日
一次修了 (実際)
2020年1月24日
研究の完了 (実際)
2020年1月24日
試験登録日
最初に提出
2017年8月20日
QC基準を満たした最初の提出物
2017年9月6日
最初の投稿 (実際)
2017年9月8日
学習記録の更新
投稿された最後の更新 (実際)
2020年1月29日
QC基準を満たした最後の更新が送信されました
2020年1月27日
最終確認日
2020年1月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Prenatal Massageの臨床試験
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