- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00360581
Preventing Postpartum Relapse to Smoking Using Yoga and Cognitive Behavioral Therapy: A Randomized Pilot Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Verenigde Staten, 15261
- University of Pittsburgh School of Nursing
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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).
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
|---|
|
smoking abstinence by CO testing
|
Secundaire uitkomstmaten
Uitkomstmaat |
|---|
|
smoking abstinence by self-report
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Susan A. Albrecht PhD, RN, FAAN, University of Pittsburgh School of Nursing
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0603012
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .