The Effect of Motivational Interviewing and Digital Game-Supported Counseling on Postpartum Relapse in Pregnant Women Who Quit Smoking: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Lokman Hekim University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Point prevalence abstinence
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Point prevalence abstinence
Time Frame: At 3 months postpartum
7-day point prevalence abstinence at 3 months postpartum
Continuous abstinence
Time Frame: At 3 months postpartum
Continuous abstinence rate at 3 months postpartum
Secondary Outcomes
- 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)
Investigators
Nurbanu Odacı
Lecturer / PhD Candidate in Public Health Nursing
Lokman Hekim University