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

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 Overview

• Status: Recruiting
• Conditions: Postpartum Period; Smoking Relapse Behavior
• Intervention / Treatment: Behavioral: Motivational Interviewing and Digital Game-Supported Counseling; Behavioral: Routine Antenatal Care

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nurbanu ODACI; Phone Number: +905444083222; Email: nur_banu_odaci@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye)
      • Recruiting
      • Lokman Hekim Universty
      • Contact: Nurbanu ODACI; Phone Number: %905444083222; Email: nur_banu_odaci@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Participants will receive counseling supported by motivational interviewing and a digital game.	Behavioral: 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.
Active Comparator: Control Group; Participants receive routine antenatal care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Point prevalence abstinence	7-day point prevalence abstinence at 3 months postpartum	At 3 months postpartum
Continuous abstinence	Continuous abstinence rate at 3 months postpartum	At 3 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	At baseline, and at 1, 2, and 3 months postpartum
Prevalence of slips	Prevalence of slips	At 1, 2, and 3 months postpartum

Collaborators and Investigators

• Sponsor: Lokman Hekim University
• Investigators: Study Director: Bilge KALANLAR, Hacettepe Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 12, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Antenatal care; Smoking relapse; Digital Game
• Additional Relevant MeSH Terms: Health Services; Health Care Facilities Workforce and Services; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Motivational Interviewing
• Other Study ID Numbers: LokmanHekimU-Hem-NO-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No