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Pregnancy, Mindfulness, and Massage

27. januar 2020 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Yale Child Study Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: 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.
Annen: 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.
Annen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yale University

Samarbeidspartnere

Massage Therapy Foundation

Etterforskere

  • Hovedetterforsker: Michael Paidas, MD, Yale University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. november 2017

Primær fullføring (Faktiske)

24. januar 2020

Studiet fullført (Faktiske)

24. januar 2020

Datoer for studieregistrering

Først innsendt

20. august 2017

Først innsendt som oppfylte QC-kriteriene

6. september 2017

Først lagt ut (Faktiske)

8. september 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 2000021692

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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