The Effect of Motivational Interview Attempt on Self-Efficacy Level and Decision to Quit Smoking of University Students

April 6, 2022 updated by: Feyza Dereli, Izmir Katip Celebi University
This study aimed to determine the effect of motivational interview initiatives on the smoking cessation decisions of university students. In this study, which will be conducted as a randomized, case-control study; Student introduction form, Fagerström Nicotine Addiction Test, Decision-Making Balance Scale, Self-efficacy adequacy scale, Behavior Change Stage Diagnosis Short Questionnaire, Beck Depression Scale, Smoking Desire Scale will be used, CO will be measured. Motivational interview initiative will be applied to first-year students who are enrolled in the university, who smoke and are considering quitting. The estimated duration of the study is 8-10 months. Maximum number of volunteers will be 60.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

More than 7 million people in the world and more than 100,000 people in Turkey die from diseases related to tobacco use annually. Young people are one of the most important target groups of the tobacco industry. For these reasons, one of the goals in the international and national (Tobacco Control Strategy Document and Action Plan 2018-2023 for Turkey) tobacco control programs is to include protective, preventive and therapeutic studies, especially for children and youth. Currently, there are two treatment approaches recommended for smoking cessation. They are pharmacological treatment and behavioural treatment/motivation. The aim of this study is to evaluate the effect of the motivational interview initiative on the self-efficacy level of university students and their decision to quit smoking.

The research will be conducted in a randomized, intervention-control group experimental research design. The study will be carried out on first-year students of a university. The universe of the research; 1st-year students (N: 4543) registered in the 2020-2021 academic year. The number of students to be reached after the announcement was determined as 358 by using the 72% value, which is the result of the smoking status determination survey conducted at the same university in the 2019-2020 academic year in the previous year, using the sample calculation method with the known universe.

The study will be announced on the website of the university where the research will be conducted for first-year students who smoke and want to quit. Students who want to participate, who have not been diagnosed with depression and whose Beck depression score is mild and minimally depressed will constitute the sample group.

The sample size was calculated using power analysis. Self-efficacy and efficacy score effect size between intervention and control was calculated as 0.49 and n=23 students from each group were calculated, with a 0.05 margin of error and Power of 83.83%. As a result of the sample number calculation, 23 intervention and 23 control group students should be included. Considering that there may be losses in the later stages of the study, 40 students will be included in the study for each group. In line with the feasibility of education and training during the pandemic process, face-to-face and online interviews will be held with the hybrid interview method. Students willing to quit smoking will be divided into control and intervention groups using the simple random sampling technique according to the random numbers assignment list created in the Excel program by the biostatistics expert. In order to avoid bias, students will not be informed about which group they are in by using the single-blind study technique.

Motivational interviews and related scales will be applied to the students in the initiative group and CO measurement will be made. In cases where it is not appropriate to measure CO due to pandemic conditions, students will not be able to measure it. Such cases will be recorded in the data collection form.

After the research, motivational interviews will be made to the students in the control group who want to support their decision to quit smoking.

The researcher who will conduct the interviews has received motivational interview technique training. For the individual motivational interview to be held with the students in the intervention group, the researcher will make the first interview by determining the appropriate times with the students. Afterwards, motivational interviews will be held at the 1st, 3rd and 6th months, in which relapses and behavioural changes are evaluated (Behavioral Change Stage Diagnosis Short Questionnaire). Interviews are planned to be conducted using a hybrid method (face-to-face or online).

In the first of the individual interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make and evaluate CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply a motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or take the measurement results made by the students in the smoking cessation polyclinics and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales to both groups for approximately 10-15 minutes, to make CO measurements or to get the measurement results.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • İzmir, Turkey
        • İzmir Katip Çelebi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Students in Year 1
  2. Smoker,
  3. 18 years and older,
  4. Those who have not received a psychiatric diagnosis made by the physician,
  5. Those who want to quit smoking,
  6. Volunteer students who accept the motivational interview.

Exclusion Criteria:

  1. Non-smokers,
  2. 18 years old and under,
  3. Taking the course of the researcher teacher due to vulnerability,
  4. Students who do not want to participate voluntarily will not be included.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional group
32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting.
In the first interviews with the students; It is planned to provide information about acquaintance and research, fill in the scales in 10-15 minutes, make CO measurements, and also conduct an average of 20-40 minutes of motivational interviews in the intervention group. In the second interview in the 1st month, it is planned to summarize the first interview, fill in the scales in 3-5 minutes, make the CO measurements in 10-15 minutes or get the measurement results and apply motivational interview in the average of 20-40 minutes. In the third interview in the 3rd month, it is planned to summarize the second interview in 3-5 min, fill in the scales in 10-15 minutes, make CO measurements or get the measurement results and to apply motivational interviews for an average of 20-40 minutes. In the last interview in the 6th month, it is planned to summarize the 3rd-month interview, to apply the scales for approximately 10-15 minutes, to make CO measurements or to get the measurement results.
No Intervention: Control group
32 randomly selected first-year students in the university, who voluntarily agreed to be recruited into the study and smoke and are considering quitting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of people who quit smoking
Time Frame: Six months
The number of people who quit smoking in the groups at the end of the study.
Six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fagerström Test for Nicotine Dependence
Time Frame: Six months
Fagerström Test for Nicotine Dependence
Six months
Decision Making Balance Scale
Time Frame: Six months
Decision Making Balance Scale
Six months
Self-efficacy adequacy scale
Time Frame: Six months
Self-efficacy adequacy scale
Six months
Behavior Change Stage Diagnosis Short Questionnaire
Time Frame: Six months
Behavior Change Stage Diagnosis Short Questionnaire
Six months
Smoking desire scale
Time Frame: Six months
Smoking desire scale
Six months
CO Measurement
Time Frame: Six months
CO Measurement
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

April 6, 2022

First Submitted That Met QC Criteria

April 6, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 1071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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