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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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 reinfor
• Поведенческое 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.

Первичные конечные точки

• Point prevalence abstinence [Срок оценки: At 3 months postpartum]
• Continuous abstinence [Срок оценки: At 3 months postpartum]

Вторичные конечные точки (3)

• Motivation for smoking abstinence [Срок оценки: At baseline, and at 1, 2, and 3 months postpartum]
• Level of cigarette craving [Срок оценки: At baseline, and at 1, 2, and 3 months postpartum]
• Prevalence of slips [Срок оценки: At 1, 2, and 3 months postpartum]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Lokman Hekim Universty — Ankara

Идентификаторы

NCT: NCT07271953 · LokmanHekimU-Hem-NO-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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