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Completed

NCT Number: NCT07775755

Virtual Reality (VR)and Mobile-Based Smoking Cessation in Breastfeeding Mothers

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.

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Key information

Conditions

Smoking Cessation Behavior Breast Feeding Chemically-Induced Disorders Feeding Behavior Health Behavior Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus State Hospital

Tarsus, Mersin, 33460, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality and Mobile Application-Based Smoking Cessation Education

Behavioral

Participants in the intervention group viewed an educational video on smoking cessation using virtual reality (VR) glasses and a mobile application.

Primary outcomes

  1. Change in nicotine dependence measured by the Fagerström Test for Nicotine Dependence (FTND)

    Time frame: Baseline, 1 month, 2 months, 4 months, and 6 months

    Nicotine dependence was assessed using the Fagerström Test for Nicotine Dependence (FTND). The primary outcome was the change in FTND score from baseline to the 6-month follow-up. Higher scores indicate greater nicotine dependence.

  2. Change in Nicotine Dependence Measured by the Fagerström Test for Nicotine Dependence (FTND)

    Time frame: Baseline, 1 month, 2 months, 4 months, and 6 months

    The primary outcome was the change in nicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND). The FTND is a six-item questionnaire with total scores ranging from 0 to 10, where higher scores indicate greater nicotine dependence. Changes in FTND scores were compared between the intervention and control groups throughout the follow-up period.

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Investigation of the Effect of Educational Video Watched With Virtual Reality Glasses and Mobile Application on Smoking Cessation in Breastfeeding Mothers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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