Postpartum PeriodNCT07271953
The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse
A study testing Motivational Interviewing and Digital Game-Supported Counseling and Routine Antenatal Care in people with Postpartum Period and Smoking Relapse Behavior, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to determine the effect of motivational interviewing-based, digital game-supported counseling on postpartum smoking relapse among pregnant women who quit smoking spontaneously during pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Period, Smoking Relapse Behavior
- What is being tested?
- Motivational Interviewing and Digital Game-Supported Counseling and Routine Antenatal Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 12 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged ≥18 years
- Being in the second trimester of pregnancy
- Smoked at least one cigarette per day before pregnancy and quit smoking during the first trimester of pregnancy
- Have internet access
- Own a device capable of playing the digital game (e.g., smart phone, tablet, or computer)
- Native Turkish speakers
Who cannot join
- Having a diagnosis of any psychiatric disorder
- Currently using another pharmacological or behavioral smoking cessation method
- Having a high-risk pregnancy
- Withdrawal Criteria:
- Experience pregnancy termination for any reason
- Do not participate in any stage of the counseling sessions
- Are diagnosed with postpartum depression during the postpartum period
- Resume smoking during pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Lokman Hekim Universty
Ankara, Ankara
Nurbanu ODACI, %905444083222, nur_banu_odaci@hotmail.com
About this study
Official title: The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse in Pregnant Women Who Quit Smoking: A Randomized Controlled Trial
This randomized controlled trial aims to determine the effect of motivational interviewing-based, digital game-supported counseling on postpartum smoking relapse among pregnant women who quit smoking spontaneously during pregnancy. Women who smoked at least one cigarette per day before pregnancy and quit smoking during pregnancy will be included. Participants will be randomly assigned to two groups: in the intervention group, online motivational interviewing sessions will be delivered once each during the third and fourth prenatal follow-ups by the researcher, and a digital game assignment will be provided after each session; the control group will receive routine health counseling delivered during prenatal follow-ups. The primary outcome measure is the rate of smoking relapse at three months postpartum. Secondary outcome measures include the postpartum slip rate, craving to smoke, and motivation to remain abstinent.
- Conditions
- Postpartum Period, Smoking Relapse Behavior
- Being tested
- Motivational Interviewing and Digital Game-Supported Counseling, Routine Antenatal Care
- Keywords
- Motivational Interviewing, Digital Game, Antenatal care, Smoking relapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Digital Game-Supported CounselingBehavioural
Collaborative, autonomy-supportive counseling delivered in two structured sessions using motivational interviewing techniques, scheduled during the 3rd and 4th routine antenatal visits. The counseling focuses on sustaining abstinence, coping with cues, relapse prevention, and managing partner/household exposure. Each session follows a manualized protocol, with a session checklist completed at every visit. After each session, participants are assigned a digital game-based task designed to reinforce key counseling themes and support behavior maintenance.
Routine Antenatal CareBehavioural
Routine antenatal care is provided at the study hospital according to the Ministry of Health's pregnancy follow-up program, which includes visits at ≤14 weeks, 18-24 weeks, 28-32 weeks, and 36-38 weeks of gestation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive counseling supported by motivational interviewing and a digital game. Receives: Behavioral: Motivational Interviewing and Digital Game-Supported Counseling |
| Control Group | Active comparator | Participants receive routine antenatal care Receives: Behavioral: Routine Antenatal Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point prevalence abstinence
7-day point prevalence abstinence at 3 months postpartum
Measured: At 3 months postpartum
Continuous abstinence
Continuous abstinence rate at 3 months postpartum
Measured: At 3 months postpartum
Secondary outcomes (3)
Motivation for smoking abstinence
Assessed using the Turkish version of the Abstinence-Related Motivational Engagement (ARME) Scale, which evaluates participants' motivation to maintain smoking abstinence through total scale scores.
Measured: At baseline, and at 1, 2, and 3 months postpartum
Level of cigarette craving
Measured using a self-reported 0-10 rating scale for cigarette craving (0 = no craving, 10 = extreme craving).
Measured: At baseline, and at 1, 2, and 3 months postpartum
Prevalence of slips
Prevalence of slips
Measured: At 1, 2, and 3 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Oct 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion12 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum PeriodStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled experimental study with pre-test post-test parallel design
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nurbanu Odacı, Lokman Hekim University
- Investigators
- Bilge KALANLAR, Study director, Hacettepe Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271953
- Sponsor's protocol ID
- LokmanHekimU-Hem-NO-02
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse in Pregnant Women Who Quit Smoking: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07271953
- Acronym / sponsor ID
- LokmanHekimU-Hem-NO-02
- Conditions
- Postpartum Period, Smoking Relapse Behavior
- Keywords
- Motivational Interviewing, Digital Game, Antenatal care, Smoking relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 12 Jul 2026 (estimated)
- First posted
- 9 Dec 2025 (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 aims to determine the effect of motivational interviewing-based, digital game-supported counseling on postpartum smoking relapse among pregnant women who quit smoking spontaneously during pregnancy. Women who smoked at least one cigarette per day before pregnancy and quit smoking during pregnancy will be included. Participants will be randomly assigned to two groups: in the intervention group, online motivational interviewing sessions will be delivered once each during the third and fourth prenatal follow-ups by the researcher, and a digital game assignment will be provided after each session; the control group will receive routine health counseling delivered during prenatal follow-ups. The primary outcome measure is the rate of smoking relapse at three months postpartum. Secondary outcome measures include the postpartum slip rate, craving to smoke, and motivation to remain abstinent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled experimental study with pre-test post-test parallel design
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Motivational Interviewing and Digital Game-Supported CounselingParticipants will receive counseling supported by motivational interviewing and a digital game. |
| Control Group | Active comparator | Behavioral: Routine Antenatal CareParticipants receive routine antenatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥18 years
- Being in the second trimester of pregnancy
- Smoked at least one cigarette per day before pregnancy and quit smoking during the first trimester of pregnancy
- Have internet access
- Own a device capable of playing the digital game (e.g., smart phone, tablet, or computer)
Key exclusion criteria (8 listed)
- Having a diagnosis of any psychiatric disorder
- Currently using another pharmacological or behavioral smoking cessation method
- Having a high-risk pregnancy
- Experience pregnancy termination for any reason
- Do not participate in any stage of the counseling sessions
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 |
|---|---|---|
| Motivational Interviewing and Digital Game-Supported CounselingCollaborative, autonomy-supportive counseling delivered in two structured sessions using motivational interviewing techniques, scheduled during the 3rd and 4th routine antenatal visits. The counseling focuses on sustaining abstinence, coping with cues, relapse prevention, and managing partner/household exposure. Each session follows a manualized protocol, with a session checklist completed at every visit. After each session, participants are assigned a digital game-based task designed to reinforce key counseling themes and support behavior maintenance. | Behavioural | Intervention Group |
| Routine Antenatal CareRoutine antenatal care is provided at the study hospital according to the Ministry of Health's pregnancy follow-up program, which includes visits at ≤14 weeks, 18-24 weeks, 28-32 weeks, and 36-38 weeks of gestation. | Behavioural | Control Group |
Primary outcome
Point prevalence abstinence
Time frame: At 3 months postpartum
7-day point prevalence abstinence at 3 months postpartum
Continuous abstinence
Time frame: At 3 months postpartum
Continuous abstinence rate at 3 months postpartum
3 secondary outcomes
Motivation for smoking abstinence
Time frame: At baseline, and at 1, 2, and 3 months postpartum
Level of cigarette craving
Time frame: At baseline, and at 1, 2, and 3 months postpartum
Prevalence of slips
Time frame: At 1, 2, and 3 months postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Bilge KALANLAR study director
Hacettepe Üniversitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Digital Game-Supported Counseling and Routine Antenatal Care in people with Postpartum Period and Smoking Relapse Behavior, run by Lokman Hekim 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurbanu ODACI (+905444083222, nur_banu_odaci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence (time frame: At 3 months postpartum). 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 9 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.