The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLokman Hekim University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Motivational Interviewing and Digital Game-Supported Counseling
BehavioralCollaborative, 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 Care
BehavioralRoutine 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.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Point prevalence abstinence
7-day point prevalence abstinence at 3 months postpartum
Time frame
At 3 months postpartum2
Continuous abstinence
Continuous abstinence rate at 3 months postpartum
Time frame
At 3 months postpartumSecondary outcomes
1
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.
Time frame
At baseline, and at 1, 2, and 3 months postpartum2
Level of cigarette craving
Measured using a self-reported 0-10 rating scale for cigarette craving (0 = no craving, 10 = extreme craving).
Time frame
At baseline, and at 1, 2, and 3 months postpartum3
Prevalence of slips
Prevalence of slips
Time frame
At 1, 2, and 3 months postpartumSponsors and contacts
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Source ClinicalTrials.gov