- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429825
Effect of a Mobile-Based Anti-Smoking Nursing Intervention on Nursing Students (HDDN) (HDDN)
The Effect of Mobile-Based Anti-Smoking Nursing Interventions on Smoking Intention, Attitude, and Decision-Making Balance of Nursing Students
This clinical trial aims to understand whether a mobile-based anti-smoking nursing intervention can help nursing students change their smoking-related intentions, attitudes, and decision-making. The study focuses on nursing students who currently smoke.
The main questions this study aims to answer are:
Does the mobile-based nursing intervention reduce nursing students' intention to smoke?
Does the intervention change students' attitudes toward smoking?
Does the intervention affect how students weigh the benefits and harms of smoking when making decisions?
Researchers will compare nursing students who receive the mobile-based anti-smoking nursing intervention with students who do not receive this intervention.
Participants will use a mobile application developed by nurses. Through the application, participants will receive structured nursing support related to smoking prevention. Participants will complete questionnaires about their smoking intentions, attitudes, and decision-making at different time points during the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a randomized controlled clinical trial designed to evaluate the effect of a mobile-based anti-smoking nursing intervention on smoking intention, attitudes toward smoking, and smoking-related decision-making balance among nursing students.
Eligible participants consist of nursing students who currently smoke. Following baseline assessments, participants are randomly assigned to either the intervention group or the control group to ensure comparability between groups at the start of the study.
Participants in the intervention group receive a mobile-based anti-smoking nursing intervention developed within the framework of the nursing process. The intervention is delivered through a structured mobile application and provides planned nursing support aimed at increasing awareness, supporting behavior change, and strengthening smoking-related decision-making. The intervention content is delivered over a defined period and is designed to promote active engagement.
Participants in the control group do not receive the mobile-based nursing intervention and continue under usual conditions throughout the study period.
Data are collected at baseline and at predefined follow-up time points using validated scales and a structured questionnaire. Smoking intention is assessed using the Smoking Intention Questionnaire, attitudes toward smoking are measured with the Smoking Attitudes Scale, and smoking-related decision-making balance is evaluated using the Smoking Decision Balance Scale. Changes over time are analyzed by comparing outcomes between the intervention and control groups.
This study is conducted as part of a doctoral dissertation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bornova
-
Izmir, Bornova, Turkey (Türkiye), 35100
- Ege University Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being an undergraduate student currently enrolled at Ege University Faculty of Nursing
- Volunteering to participate in the study and providing written informed consent
- Smoking one or more cigarettes per day
- Owning a smartphone with either iOS or Android operating system and having regular internet access
- Having no prior participation in any smoking cessation intervention study
Exclusion Criteria:
- Having previously participated in a smoking cessation intervention program or study
- Being a non-smoker
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group-Mobile-based nursing intervention delivered through the HDDN
Participants receive a mobile-based nursing intervention delivered through the HDDN (Hemşire Destekli Dumansız Nefes) mobile application
|
The intervention is a mobile-based nursing intervention designed to prevent smoking and support positive health behavior change among nursing students. It is delivered through a smartphone application compatible with iOS and Android operating systems. The intervention includes structured educational modules, motivational messages, and self-monitoring activities focused on smoking-related intention, attitudes, and decision-making balance. Participants receive reminder notifications twice daily during the intervention period. In addition, the application provides nurse-guided support through a messaging feature that allows participants to ask questions and receive guidance. The content of the intervention is based on established behavior change theories and is standardized to ensure that all participants receive the same intervention |
|
No Intervention: Control Group
Participants assigned to the control group did not receive any intervention.
They continued their usual activities without access to the mobile application or any additional nursing support.
Smoking-related attitudes, intentions, and decision-making balance were assessed at baseline, 22 days after baseline, and one month after the first follow-up using self-report questionnaires administered online
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Intention
Time Frame: Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up)
|
Measured using the Smoking Intention Questionnaire (SIQ).
The questionnaire consists of 4 items assessing trying, craving, planning, and thinking.
Each item is rated on a 5-point Likert scale (1-5).
Total scores range from 4 to 20.
Higher scores indicate stronger intention to smoke (worse outcome), whereas lower scores indicate weaker intention to smoke (better outcome).
|
Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up)
|
|
Attitudes toward smoking
Time Frame: Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up).
|
Measured using the Attitudes Toward Smoking Scale.
The scale consists of 45 items rated on a 6-point Likert scale (1-6).
Total scores range from 45 to 270.
Higher scores indicate more positive attitudes toward smoking (worse outcome), whereas lower scores indicate more negative attitudes toward smoking (better outcome).
|
Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up).
|
|
Smoking decision-making balance
Time Frame: Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up).
|
Measured using the Smoking Decisional Balance Scale.
The scale consists of 24 items rated on a 5-point Likert scale (1-5), including 11 items assessing perceived benefits of smoking (score range 11-55) and 13 items assessing perceived harms of smoking (score range 13-65).
The decisional balance score is calculated by subtracting the perceived harms score from the perceived benefits score.
Total scores range from -54 to +42.
Positive scores indicate that perceived benefits outweigh harms (worse outcome), whereas negative scores indicate that perceived harms outweigh benefits (better outcome).
|
Baseline (Pre-test), 22 days after baseline (1st Follow-up), and 1 month after the first follow-up (2nd Follow-up).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Smoking Cessation Behavior.
Time Frame: During the 14-day intervention period.
|
Percentage of participants who reported "I no longer smoke" for at least 7 days during the 14-day mobile application intervention period, tracked via self-control diaries.
|
During the 14-day intervention period.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Şafak Dağhan, PhD, Prof., Ege University Faculty of Nursing
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- YOKTEZ-10755404
- TUBITAK PROJECT NO:223S832 (Other Grant/Funding Number: THESCİENTİFİC AND TECHNOLOGİCAL RESEARCH COUNCİL OF TURKEY (TUBITAK))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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