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

NCT05173428 | Completed

• 1 other identifier: SCU-BECEVIK-001
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Smoking, Tobacco

Keywords

Motivational Interviews; Transtheoretic Model; Pregnancy

Outcome Measures

Primary Outcomes (4)

• Smoking-Cessation Success Prediction Scale

  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.

  6 months

• Decisional Balance Scale

  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.

  6 months

• Self-Efficacy Level Scale

  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.

  6 months

• Fagerstrom Test For Nicotine Dependence

  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.

  6 months

Study Arms (2)

Interventional Gruop

EXPERIMENTAL

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

Control Gruop

NO INTERVENTION

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.

Interventions

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.

Interventional Gruop

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Study Officials

• Semra ZORLU, PhD

  Cumhuriyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 30, 2021
• Study Start: December 30, 2021
• Primary Completion: July 30, 2022
• Study Completion: November 30, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

TU (1)