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Completed
NCT07775755
Virtual Reality (VR)and Mobile-Based Smoking Cessation in Breastfeeding Mothers
Conditions: Smoking Cessation, Tobacco Use Disorder, Breast Feeding
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Kahramanmaras Sutcu Imam University
Location: Tarsus State Hospital Tarsus Mersin
Summary
This randomized controlled trial was conducted to evaluate the effect of an educational video delivered through virtual reality (VR) glasses and a mobile application on smoking cessation behavior among breastfeeding mothers.
The study was carried out in the breastfeeding outpatient clinic of a secondary-level public hospital. A total of 76 breastfeeding mothers with infants aged 0-6 months who reported active cigarette smoking were enrolled. Participants were randomly assigned to either an intervention group (n = 35) or a control group (n = 41) using a simple randomization method. Mothers in the intervention group viewed an educational video through VR glasses and a mobile application that provided evidence-based information on the harmful effects of smoking on maternal and infant health and encouraged smoking cessation. The control group received routine breastfeeding care and counseling provided by the clinic.
Participants were followed for six months, with assessments performed at baseline and at the 1st, 2nd, 4th, and 6th months after the intervention. Data were collected using the Personal Information Form, the Fagerström Test for Nicotine Dependence, and the Questionnaire of Smoking Urges-Brief. The primary objective was to evaluate changes in nicotine dependence and smoking urges over the follow-up period and to determine the effectiveness of the VR- and mobile application-based educational intervention in supporting smoking cessation among breastfeeding mothers.
Eligibility Criteria
Inclusion Criteria:
* Mother must be 18 years of age or older
* Mothers who have a baby aged 0-6 months and are breastfeeding
* Smoking
* Mother and baby must be healthy
* Mother must own a smartphone and be able to use it
* Volunteer to participate in the study (Volunteering by signing the Informed Consent Form)
* Having a low level of dependence according to the FNTD score (having scored 3 points or higher),
* Not having Postpartum Depression according to the EPDS score (having scored below 12 points).
Exclusion Criteria:
* Mother or baby having a health problem
* Having communication problems
Source: ClinicalTrials.gov (NCT07775755). StuddyBuddy aggregates publicly available trial information.