ClinicalTrials.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

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jan 2026, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies in Smoking Cessation with a site in Turkey — 5 open to participants now, 6 under way, none of them phase 3. Smoking Cessation · Turkey.

Enrollment
16th of 20
76 · median 102
Started
2026
with 3 others
No phase
20 of 24
3 open now
Registered
20th of 24
by date
Lead sponsor
1 of 24
Kahramanmaras Sutcu Imam University

Among the 24 studies in Smoking Cessation with a site in Turkey, this one is the 16th largest by enrollment of the 20 interventional ones that give a count, is one of 4 that started in 2026, is one of 20 with no phase, and was the 20th registered.

Smoking Cessation

1,582 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

Browse Smoking Cessation studies →

Open to participants now

5 of the 24 studies in Smoking Cessation with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 137 Smoking Cessation studies recruiting now, 93 (68%) set no upper age limit and 37 (27%) stop at 75 or younger; 6 take children under 18; 41 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies in Smoking Cessation with a site in Turkey, or all of them as a file.
02

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.

03

Conditions studied

  • Smoking Cessation
  • Tobacco Use Disorder
  • Breast Feeding

Keywords

  • Breastfeeding Mother
  • Quitting Smoking
  • Virtual Reality
  • Mobile Application
  • Nicotine Dependence
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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.

06

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

07

Study locations

1 site
  • Tarsus State Hospital
    Tarsus, Mersin 33460, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2026 to primary completion in Jan 2026, 0 months.

Of 547 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's 0 months is below that.

Counting every sponsor, half of 564 studies reached it within 24 months; a quarter within 12 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2026
First posted
Aug 20, 2026
StartActual
Jan 1, 2026
Primary completionActual
Jan 1, 2026
CompletionActual
Jan 1, 2026
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07775755
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
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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