Skip to main content
OpenTrials
Completed

NCT Number: NCT05173428

The Effect of Motivational Interviews Based on the Transtheoretic Model on Pregnant Women's Smoking Cessation Behaviors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Smoking Cessation Program Based on Transtheoretic Model

Behavioral

Conducting motivational interviews based on the transtheoretic model according to the stages of change that individuals are in.

Primary outcomes

  1. Smoking-Cessation Success Prediction Scale

    Time frame: 6 months

    The scale consists of 10 items.Items in the scale are evaluated with a 5-point Likert scale (1: too little, 2: little, 3: middle, 4: a little too much, 5: much).The maximum score that can be obtained from the scale is 50, and the minimum score is 10. Scale score indicates that the success of smoking cessation will be high.

  2. Decisional Balance Scale

    Time frame: 6 months

    The scale, which has 24 items, consists of two sub-dimensions: "Positive aspects of smoking" and "Negative aspects of smoking". Each item of the scale is scored from 1 to 5 as 1- I strongly disagree, 2- I do not agree, 3- I neither agree nor disagree, 4- I agree, 5- I completely agree.For both sub-dimensions, the minimum score that can be obtained from the scale is 12, and the maximum score is 60.Scale total score; It is calculated by subtracting the perceived harm total score of smoking from the total perceived benefit score of smoking. The negative (-) result indicates that the perceived harms of smoking are dominant in the decision-making balance. The positive (+) result indicates that the perceived benefits of smoking are dominant in the decision-making balance.

  3. Self-Efficacy Level Scale

    Time frame: 6 months

    The scale consists of 23 items and 4 sub-dimensions: starting the behavior, maintaining the behavior, completing the behavior and struggling with obstacles.For each item in the scale; 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well.A minimum of 23 and a maximum of 115 points can be obtained from the scale. The high total score obtained from the scale indicates that the general self-efficacy perception is high.

  4. Fagerstrom Test For Nicotine Dependence

    Time frame: 6 months

    The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.

    In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2021
Registry last updated
Feb 10, 2023

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.