Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07271953

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postpartum Period Smoking Relapse Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lokman Hekim Universty

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nurbanu ODACI

CONTACT

[email protected]

%905444083222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Point prevalence abstinence

    Time frame: At 3 months postpartum

    7-day point prevalence abstinence at 3 months postpartum

  2. Continuous abstinence

    Time frame: At 3 months postpartum

    Continuous abstinence rate at 3 months postpartum

Secondary outcomes

  1. Motivation for smoking abstinence

    Time frame: At baseline, and at 1, 2, and 3 months postpartum

    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.

  2. Level of cigarette craving

    Time frame: At baseline, and at 1, 2, and 3 months postpartum

    Measured using a self-reported 0-10 rating scale for cigarette craving (0 = no craving, 10 = extreme craving).

  3. Prevalence of slips

    Time frame: At 1, 2, and 3 months postpartum

    Prevalence of slips

Study contacts

Contact information is provided by the study sponsor or research team.

Nurbanu ODACI

CONTACT

[email protected]

+905444083222

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.