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

NCT07775755 | Completed

• 1 other identifier: Virtual Reality Smoking Cessat
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Tobacco Use Disorder; Breast Feeding

Keywords

Breastfeeding Mother; Quitting Smoking; Virtual Reality; Mobile Application; Nicotine Dependence

Outcome Measures

Primary Outcomes (2)

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

  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.

  Baseline, 1 month, 2 months, 4 months, and 6 months

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

  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.

  Baseline, 1 month, 2 months, 4 months, and 6 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Breastfeeding mothers in the experimental group received routine breastfeeding care in addition to viewing an educational video on smoking cessation delivered through virtual reality glasses and a mobile application. The intervention aimed to increase awareness of the harmful effects of smoking on maternal and infant health and to support smoking cessation. Participants were followed for six months.

Behavioral: Virtual Reality and Mobile Application-Based Smoking Cessation Education

Control

NO INTERVENTION

Participants in the control group received routine breastfeeding care and standard counseling provided by the breastfeeding clinic. They did not receive the virtual reality- and mobile application-based smoking cessation education.

Interventions

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Mother or baby having a health problem
• Having communication problems

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Tarsus State Hospital

Tarsus, Mersin, 33460, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Breast Feeding

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Feeding Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 20, 2026
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-07

Locations

TU (1)