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

NCT ID: NCT05173428

Last Updated: 2023-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-30

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation Smoking, Tobacco

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Smoking Cessation Program Based on Transtheoretic Model

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Betul Esra Cevik

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Semra ZORLU, PhD

Role: STUDY_DIRECTOR

Cumhuriyet University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SCU-BECEVIK-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.