RecruitingNot ApplicableNCT07271953

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

Sponsor

Lokman Hekim University

Enrollment

72 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Postpartum Period Smoking Relapse Behavior

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

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 Criteria8

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

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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.

BEHAVIORALRoutine Antenatal Care

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.