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

NCT07271953 | Recruiting

• 1 other identifier: LokmanHekimU-Hem-NO-02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Period; Smoking Relapse Behavior

Keywords

Motivational Interviewing; Digital Game; Antenatal care; Smoking relapse

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Motivation for smoking abstinence

  At baseline, and at 1, 2, and 3 months postpartum

• Level of cigarette craving

  At baseline, and at 1, 2, and 3 months postpartum

• Prevalence of slips

  At 1, 2, and 3 months postpartum

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Motivational Interviewing and Digital Game-Supported Counseling

Control Group

ACTIVE COMPARATOR

Participants receive routine antenatal care

Behavioral: Routine Antenatal Care

Interventions

Motivational Interviewing and Digital Game-Supported Counseling 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.

Intervention Group

Routine Antenatal Care 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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Lokman Hekim Universty

Ankara, Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Bilge KALANLAR

  Hacettepe Üniversitesi

  STUDY DIRECTOR

Central Study Contacts

Nurbanu ODACI

CONTACT

+905444083222; nur_banu_odaci@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer / PhD Candidate in Public Health Nursing

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

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 12, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)