CClinicalTrials.gg
CompletedNCT07775755Updated Aug 20, 2026

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

An interventional study of Virtual Reality and Mobile Application-Based Smoking Cessation Education in Smoking Cessation, Tobacco Use Disorder and Breast Feeding, sponsored by Kahramanmaras Sutcu Imam University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Smoking Cessation
  • Tobacco Use Disorder
  • Breast Feeding

Keywords

  • Breastfeeding Mother
  • Quitting Smoking
  • Virtual Reality
  • Mobile Application
  • Nicotine Dependence
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Mother or baby having a health problem
  • Having communication problems
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Experimental Group

    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

  • No intervention
    Control

    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

  • BehavioralVirtual Reality and Mobile Application-Based Smoking Cessation Education

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

05

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

06

Study locations

1 site
  • Tarsus State Hospital
    Tarsus, Mersin 33460, Turkey (Türkiye)
07

Registry details

Key details

Study ID
NCT07775755
Lead sponsor
Kahramanmaras Sutcu Imam University
Collaborators
The Scientific and Technological Research Council of Turkey
Responsible party
Mine Gokduman Keles (Assistant Professor, Burdur Mehmet Akif Ersoy University) — Principal investigator
First posted
Aug 20, 2026
Start date
Jan 1, 2026
Primary completion
Jan 1, 2026
Completion
Jan 1, 2026
Last update
Aug 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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