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Pregnancy, Mindfulness, and Massage

27. januar 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale Child Study Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: 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.
Andet: 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.
Aktiv komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tobacco Use Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Number of cigarettes smoked in past 24 hours
Up to 4 weeks
Withdrawal Symptoms Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Mood and Physical Symptoms Scale
Up to 4 weeks
Nicotine Dependence Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
FTND (Fagerstrom Test for Nicotine Dependence) measure
Up to 4 weeks
Depression Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
EPDS (Edinburgh Postnatal Depression Scale) measure
Up to 4 weeks
Anxiety Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Beck Anxiety Inventory
Up to 4 weeks
Stress Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Perceived Stress Scale
Up to 4 weeks
Daily Stress Scores Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Diary Measure
Up to 4 weeks
Daily Tobacco Usage Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Diary Measure
Up to 4 weeks
Heart Rate Variability Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
Maternal heart rate variability measured at rest
Up to 4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neonatal Outcomes
Tidsramme: Up to 2 months
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
Tidsramme: Up to 4 weeks
Fetal heart rate measured at rest
Up to 4 weeks
Engagement with Craving to Quit
Tidsramme: Up to 4 weeks
Engagement with the Craving to Quit app
Up to 4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CO (carbon monoxide) monitoring Change from Baseline to Post-Intervention
Tidsramme: Up to 4 weeks
breath test
Up to 4 weeks
MINI (Mini International Neuropsychiatric Interview) Substance Dependence
Tidsramme: Enrollment
determine other substance use disorders
Enrollment
Self-Reported Mood at each Massage Therapy Session for Intervention Group
Tidsramme: Up to 3 weeks
positive and negative mood, including stress
Up to 3 weeks
Mind-mindedness related to infant
Tidsramme: Up to 2 months
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Yale University

Samarbejdspartnere

Massage Therapy Foundation

Efterforskere

  • Ledende efterforsker: Michael Paidas, MD, Yale University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. november 2017

Primær færdiggørelse (Faktiske)

24. januar 2020

Studieafslutning (Faktiske)

24. januar 2020

Datoer for studieregistrering

Først indsendt

20. august 2017

Først indsendt, der opfyldte QC-kriterier

6. september 2017

Først opslået (Faktiske)

8. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. januar 2020

Sidst verificeret

1. januar 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2000021692

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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