- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00360581
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Many women quit smoking during pregnancy, but postpartum relapse rates are high, approximately, 50-80% (Van't Hof, et al). The majority of women who quit smoking during pregnancy resume smoking within the first 3 months postpartum (McBride, et al). The environmental risks of tobacco smoke on the newborn child can lead to acute respiratory infections, bronchitis, pneumonia, and SIDS. Several studies have tried to identify reasons for the high rates of relapse. Postpartum relapse has been attributed to decreased self-efficacy, the lack of effective coping strategies to resist temptation to smoke, and weight concerns (McBride, et al). Addictive behaviors such as smoking are learned behavioral means of coping. By learning new rules for dealing with problems, a behavior can be modified or unlearned. Physical exercise, when combined with cognitive behavioral therapy (CBT) as a smoking cessation treatment, is useful in the maintenance of smoking cessation in women. Yoga, as a form of exercise, has been shown to promote the desire to stop smoking and enhance subjective well-being and mood. Though untested in postpartum relapse prevention, yoga practice, when coupled with CBT, may address both mood and physiologic postpartum sensations that may be associated with the prevention of smoking relapse. Women are more apt to decrease or even stop smoking during pregnancy, and if successful in sustaining cessation, are likely to live longer.
This randomized exploratory pilot study will use a controlled parallel group design using smoking cessation yoga intervention and cognitive behavioral therapy. The study will include a total of 30 participants aged 18-45 years. Smoking status will be identified by self-report and carbon monoxide testing at enrollment. At randomization and following time points, smoking status will be identified by self-report and confirmed by carbon monoxide testing.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stati Uniti, 15261
- University of Pittsburgh School of Nursing
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Must have the ability to read, write, and understand English.
- Must have quit smoking during their current pregnancy.
- Must possess the desire to remain smoke-free after delivery.
- Obtain permission from obstetrician to participate in yoga.
- Must be reachable by telephone.
- If subject becomes pregnant again while in the study, she can still participate with written permission from her primary care physician.
Exclusion Criteria:
- Untreated hypertension.
- A history of: glaucoma, major depression, alcohol abuse or substance disorder, anorexia nervosa, or head trauma.
- Recent abdominal surgery (such as caesarean section).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
|---|
|
smoking abstinence by CO testing
|
Misure di risultato secondarie
Misura del risultato |
|---|
|
smoking abstinence by self-report
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Susan A. Albrecht PhD, RN, FAAN, University of Pittsburgh School of Nursing
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 0603012
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Smettere di fumare
-
Poitiers University HospitalNon ancora reclutamentoTerapia sostitutiva della nicotina | Professionisti sanitari | Desiderio di Tabacco | Tabacco CessationFrancia
Prove cliniche su Yoga
-
University of Texas at AustinCompletato
-
Universität Duisburg-EssenCompletato
-
Northwestern UniversityCompletato
-
University of MinnesotaCompletato
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletatoDepressione | Dolore | Cancro al seno | FaticaStati Uniti
-
Saglik Bilimleri UniversitesiThe Scientific and Technological Research Council of TurkeyCompletatoFatica | Ansia | Teleriabilitazione | Yoga | Studenti universitariTacchino
-
Emory UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletatoCarcinoma della prostataStati Uniti
-
Manhattan Physical Medicine and Rehabilitation,...New York UniversityCompletato
-
Ataturk UniversityKTO Karatay UniversityReclutamentoYoga della risataTurchia (Türkiye)
-
NMP Medical Research InstituteYog-Kulam; Department of Zoology, University of Rajasthan, IndiaCompletato