The Effect of Motivational Interviewing on the Level of Self-Efficacy and Addiction in Smoking Cessation

April 27, 2023 updated by: Hacer Gok Ugur, T.C. ORDU ÜNİVERSİTESİ

The Effect of Motivational Interviewing on the Level of Self-Efficacy and Addiction in Smoking Cessation in Nursing Students: A Single-Blind Randomized Controlled Study

This study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be carried out to determine the effect of motivational interviewing on the level of self-efficacy and addiction in smoking cessation in nursing students. The study was planned as a single-blind randomized controlled experimental study. The population of the research will be composed of students studying in the 1st, 2nd and 3rd years of Ordu University and Giresun University Faculty of Health Sciences Nursing Department and who meet the research criteria, and the sample will be 90 students determined by power analysis. In the study, 30 students from Ordu University Faculty of Health Sciences Nursing Department will be in the experimental group and 30 students in the I. control group. 30 students from Giresun University Faculty of Health Sciences Nursing Department will be in the second control group. Students in the experimental group will be given a motivational interview on quitting smoking for 40-50 minutes on average once a month for 6 months. No intervention will be applied to the students in the control groups during the research process, but a motivational interview will be applied once at the end of the research in terms of ethics. The data of the research will be collected with Personal Information Form, Fagerström Nicotine Addiction Test, Self-Efficacy Scale and Stage of Change Evaluation Form. In the study, repeated measurements will be made in the 1st month, 3rd month and 6th month. Necessary institutional permission and ethics committee approval will be obtained for the research. The analysis of the data will be done by an expert statistician in a computer environment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Ordu, Turkey, 52200
        • Ordu 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a 1st, 2nd, and 3rd year student of the Nursing Department,
  • Continuing active education and training,
  • Smoker at least one cigarette a day,
  • Open to communication and cooperation, and
  • Students who volunteer to participate in the study will be included in the study.

Exclusion Criteria:

  • Fourth grade,
  • Having a serious psychiatric diagnosis (schizophrenia, bipolar disorder, psychotic disorder, etc.),
  • Receiving professional support for smoking cessation,
  • Changing schools during the research process and
  • Students who do not want to continue the research will be excluded from the research.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Motivational interview will be done to the experimental group
Other: motivational interview
Quitting smoking with motivational interviewing
No Intervention: I Control group
No intervention will be applied to the control group
No Intervention: II Control group
No intervention will be applied to the control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-Efficacy Scale
Time Frame: 1st, 3rd, and 6th months
The scale was developed by Nicki, Remington and MacDonald in 1984. This scale, which was developed based on social learning theories, is related to the individual's belief that he or she can perform a desired behavior. This scale is used in smoking cessation studies. The scale was adapted to Turkish by Karancı. The scale consists of 25 questions, each of which consists of 5 items, and is likert type. Each item score in the scale ranges from 1 to 5. The individual rates the smoking status for each item in five categories ranging from "Not at all sure:1" to "Absolutely sure:5". The scores to be taken from the scale vary between 5-25, and as the score increases, the belief that one can quit smoking increases.
1st, 3rd, and 6th months
Fagerström Test for Nicotine Dependence
Time Frame: 1st, 3rd, and 6th months
Dr. The test developed by Karl Fagerström in 1978 to evaluate the level of addiction to nicotine; It was reconsidered by Fagerström, Heatherton and Kazlowki and the Fagerström Test for Nicotine Dependence was created. In Turkish Uysal et al. Adapted by in 2004. In the test, which consists of 6 questions in total, each question is given a different score. The scale consists of 6 questions and each item is scored as 0,1,2,3, and one of the answer options should be marked. 2nd, 3rd, 5th of the scale. Since the 6th and 6th questions are 0-1 points, the points that can be obtained from the scale range from 0-10. The highest score "10" indicates the highest degree of nicotine addiction, and the lowest score "0" indicates no nicotine addiction. According to the total scores obtained as a result of the test, it is defined as 0-2: very little dependence, 3-4: little dependence, 5: moderately dependent, 6-7: high dependence, and 8-10: very high dependence.
1st, 3rd, and 6th months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
quit smoking
Time Frame: 1st, 3rd, and 6th months
quit smoking
1st, 3rd, and 6th months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
T.C. ORDU ÜNİVERSİTESİ

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ordu123

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

product manufactured in and exported from the U.S.

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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