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

Sponsor
Cumhuriyet University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05173428
Collaborator
(none)
66
2
5.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Smoking Cessation Program Based on Transtheoretic Model
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
In a randomized controlled study, blinding will be done in terms of statistician and reporting. Research data will be encoded and transferred to the computer without specifying the intervention and control group (for example; A group and B group). The analysis of these data coded in terms of groups will be done by a statistician. After the statistical analysis is done and the research report is written, the researcher will explain the coding for the intervention and control group. In this way, detection bias, statistical bias and reporting bias will be controlled.
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Jan 30, 2022
Anticipated Primary Completion Date :
May 30, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional Gruop

Online motivational interviews based on the transtheoretic model with the intervention group will be held via zoom. Data collection forms will be applied to the intervention group at the first interview, at the 3rd month as an interim monitoring, and at the 6th month as the final monitoring.

Behavioral: Smoking Cessation Program Based on Transtheoretic Model
Conducting motivational interviews based on the transtheoretic model according to the stages of change that individuals are in.

No Intervention: Control Gruop

No intervention will be made to the control group, and data collection forms will be applied at the first interview and 6 months after the first interview.

Outcome Measures

Primary Outcome Measures

  1. Smoking-Cessation Success Prediction Scale [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cumhuriyet University

Investigators

  • Study Director: Semra ZORLU, PhD, Cumhuriyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Betul Esra Cevik, Research Assistant, Cumhuriyet University
ClinicalTrials.gov Identifier:
NCT05173428
Other Study ID Numbers:
  • SCU-BECEVIK-001
First Posted:
Dec 30, 2021
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Betul Esra Cevik, Research Assistant, Cumhuriyet University

Study Results

No Results Posted as of Jan 27, 2022