Clinical trial NCT05173428: The Effect of Motivational Interviews Based on the Transtheoretic Model on Pregnant Women's Smoking Cessation Behaviors
Official title: The Effect of Online Motivational Interviews Based on the Transtheoretical Model on Pregnant Women's Prediction of Smoking Cessation Success, Self-Efficacy Levels and Smoking Cessation Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Keywords: Motivational Interviews
Transtheoretic Model
Pregnancy
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is planned to determine the effect of online motivational interviews based on the transtheoretic model on the prediction of smoking cessation success, self-efficacy levels and smoking cessation behavior of pregnant women.It is an experimental research.

Detailed description: The population of the research will be the pregnant women registered in the family health center in Sivas city center.The sample of the study will consist of pregnant women who smoke and agree to participate in the study.Power analysis was calculated using G \* Power 3.1.9.2 program. With 76% effect size, 90% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 66 individuals, 33 individuals in the intervention group and 33 individuals in the control group, by taking 10% more of the calculated sample against the possibility of sample loss during the study.Smoking Cessation Success Prediction Scale Self-Efficacy Level Scale Decision-Making Balance Scale Behavior Change Stage Diagnostic Questionnaire Fagerström Nicotine Addiction Test will be used as measurement tools.Pregnant women who agree to participate in the study will fill in the Informed Consent Form and other measurement tools.Interviews with the pregnant women in the intervention group will be held face-to-face via the Zoom application for a total of 6 times.Data collection forms will be applied to the control group at the first interview and at the last interview (6 months later), and for the intervention group at the first interview, 3 months and 6 months later, a total of 3 times.After each assessment moment, the data obtained will be exported to the "Statistical Package for Social Sciences Software" (SPSS).

Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* Not completing the 16th week of pregnancy
* Being 18 years or older
* To smoke at least 1 cigarette a day
* Being able to use a smart phone or computer and having internet
* Being literate

Exclusion Criteria:

* Unable to use a computer or smartphone
* Being at the 17th and above gestational week
* Having any mental illness
* Illiterate pregnant women

Primary outcomes:
measure: Smoking-Cessation Success Prediction Scale
timeFrame: 6 months
measure: Decisional Balance Scale
timeFrame: 6 months
measure: Self-Efficacy Level Scale
timeFrame: 6 months
measure: Fagerstrom Test For Nicotine Dependence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: Cumhuriyet University
name: Semra ZORLU, PhD
role: STUDY_DIRECTOR
References: