Smoking CessationNCT07775755
Virtual Reality (VR)and Mobile-Based Smoking Cessation in Breastfeeding Mothers
A study testing Virtual Reality and Mobile Application-Based Smoking Cessation Education in people with Smoking Cessation and Tobacco Use Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Tobacco Use Disorder, Breast Feeding
- What is being tested?
- Virtual Reality and Mobile Application-Based Smoking Cessation Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Mother or baby having a health problem
- Having communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Educational Video Watched With Virtual Reality Glasses and Mobile Application on 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.
- Conditions
- Smoking Cessation, Tobacco Use Disorder, Breast Feeding
- Being tested
- Virtual Reality and Mobile Application-Based Smoking Cessation Education
- Keywords
- Breastfeeding Mother, Quitting Smoking, Virtual Reality, Mobile Application, Nicotine Dependence
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality and Mobile Application-Based Smoking Cessation EducationBehavioural
Participants in the intervention group viewed an educational video on smoking cessation using virtual reality (VR) glasses and a mobile application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month, 2 months, 4 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07775755
- Sponsor's protocol ID
- Virtual Reality Smoking Cessat
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Educational Video Watched With Virtual Reality Glasses and Mobile Application on Smoking Cessation in Breastfeeding Mothers
- ClinicalTrials.gov ID
- NCT07775755
- Acronym / sponsor ID
- Virtual Reality Smoking Cessat
- Conditions
- Smoking Cessation, Tobacco Use Disorder, Breast Feeding
- Keywords
- Breastfeeding Mother, Quitting Smoking, Virtual Reality, Mobile Application, Nicotine Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: Virtual Reality and Mobile Application-Based Smoking Cessation EducationBreastfeeding 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Mother or baby having a health problem
- Having communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality and Mobile Application-Based Smoking Cessation EducationParticipants in the intervention group viewed an educational video on smoking cessation using virtual reality (VR) glasses and a mobile application. | Behavioural | Experimental Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Mobile Application-Based Smoking Cessation Education in people with Smoking Cessation and Tobacco Use Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.