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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-07-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Postpartum Period Smoking Relapse Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Participants will receive counseling supported by motivational interviewing and a digital game.

Group Type EXPERIMENTAL

Motivational Interviewing and Digital Game-Supported Counseling

Intervention Type BEHAVIORAL

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.

Control Group

Participants receive routine antenatal care

Group Type ACTIVE_COMPARATOR

Routine Antenatal Care

Intervention Type BEHAVIORAL

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.

Interventions

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Motivational 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.

Intervention Type BEHAVIORAL

Routine 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No