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The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse

The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse in Pregnant Women Who Quit Smoking: A Randomized Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07271953
Enrollment
72
Registered
2025-12-09
Start date
2025-10-01
Completion date
2026-07-12
Last updated
2025-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Period, Smoking Relapse Behavior

Keywords

Motivational Interviewing, Digital Game, Antenatal care, Smoking relapse

Brief 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. 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.

Interventions

BEHAVIORALMotivational Interviewing and Digital Game-Supported Counseling

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 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.

Sponsors

Lokman Hekim University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

A randomized controlled experimental study with pre-test post-test parallel design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Point prevalence abstinenceAt 3 months postpartum7-day point prevalence abstinence at 3 months postpartum
Continuous abstinenceAt 3 months postpartumContinuous abstinence rate at 3 months postpartum

Secondary

MeasureTime frameDescription
Motivation for smoking abstinenceAt baseline, and at 1, 2, and 3 months postpartumAssessed using the Turkish version of the Abstinence-Related Motivational Engagement (ARME) Scale, which evaluates participants' motivation to maintain smoking abstinence through total scale scores.
Level of cigarette cravingAt baseline, and at 1, 2, and 3 months postpartumMeasured using a self-reported 0-10 rating scale for cigarette craving (0 = no craving, 10 = extreme craving).
Prevalence of slipsAt 1, 2, and 3 months postpartumPrevalence of slips

Countries

Turkey (Türkiye)

Contacts

Primary ContactNurbanu ODACI
nur_banu_odaci@hotmail.com+905444083222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026