SmokingNCT06492772
The Effect of an Anti-Smoking Mobile Application on Self-Efficacy, Decision Making and Breath Carbon Monoxide Levels
A study testing experimental group in people with Smoking and Mobile Application, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Purpose:This research aims to examine the effect of a mobile application developed against smoking behavior on teachers' self-efficacy, decision-making and carbon monoxide levels in breath.The research was planned as a randomized controlled experimental type.Working in public schools in Izmir/Narlıdere District… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Mobile Application
- What is being tested?
- experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having a smartphone and daily internet access
- Volunteering to participate in the study
- Getting a score of 5 medium level or above according to the Fagerström Nicotine Dependency Test rules test
- Not always having any smoking cessation support or a smoking cessation intervention
Who cannot join
- Those who did not agree to participate in the research
- Those who do not smoke or have quit smoking
- Those who use any tobacco product other than cigarettes (e-cigarette, hookah, cigar, etc.)
- Those who have severe chronic health problems (vision-hearing problems, dementia and Alzheimer's, chronic lung diseases)
- Those who do not use smartphones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Mobile Application Developed Against Smoking Behavior on Teachers' Self-Efficacy, Decision Making and Breath Carbon Monoxide Levels
Purpose:This research aims to examine the effect of a mobile application developed against smoking behavior on teachers' self-efficacy, decision-making and carbon monoxide levels in breath.The research was planned as a randomized controlled experimental type.Working in public schools in Izmir/Narlıdere District teachers constitute the universe of the research. According to the calculations made, it was decided to include 35 people in the experimental group and 35 people in the control group. After obtaining institutional permissions, teachers who meet the inclusion criteria will be determined.To ensure homogeneity, control and intervention groups will be stratified according to age, gender, and addiction levels.Assignment to intervention and control groups will be made by simple randomization method.The average scores of teachers' self-efficacy, breath carbon monoxide and decision-making levels are the dependent variables of the study.The status of using the mobile application is the independent variable. "Personal Information Form", "Fagerstrom Nicotine Dependency Test (FNBT)", "Self-Efficacy Scale", "Classification of Stages of Change Scale", "Decision Making Scale" and "Carbon Monoxide Measurement Values Tracking Form" will be used in this research. SPSS 26.0 Package program will be used to analyze the data in the study. It will be evaluated statistically at a 95% confidence interval and a significance level of p<0.05. Number and percentage distributions for sociodemographic characteristics will be used in the analysis of the data.In comparisons between groups, parametric or nonparametric tests will be used after evaluating the normal distribution feature of the scale scores.
Hypotheses 1 H1:There is a difference between the breath CO level scores of intervention and control group teachers according to time (pre-test - 1st month, 3rd month and 6th month).
Read more
Hypotheses 2 H1:There is a difference between the self-efficacy scale scores of intervention and control group teachers according to time (pre-test, 1st month, 3rd month, 6th month).
Hypotheses 3 H1: There is a difference between the decision-making level scores of teachers in the intervention and control groups according to time (pretest-1st month, 3rd month and 6th month).
Read the detailed description
Smoking is one of the leading preventable causes of disease. According to global adult tobacco survey data, 19.2 million people (31.6%) in Turkey use tobacco products (KYTA, 2016). The rate of individuals over the age of 15 who use tobacco products every day is announced as 28.3% in TUIK 2022 data. Smoking rates of teachers were found to be between 29.1 and 52.4% in studies conducted in Turkey (Perincek, 2021). Teachers are the most important exemplary community in the school, with their identity as educators and their function as role models in society. Teachers with nicotine addiction must smoke during school hours.However, there is a negative relationship between teachers' desire to smoke and their personal success (Becet A.,2019). In a study, it was stated that transtheoretic model-based education increased teachers' anti-smoking attitudes and reduced nicotine addiction (Mermer et al. 2016). Studies indicate that the presence of teachers who smoke at school is associated with students' smoking behavior (Radha et al.,2019; Kjeld et al.,2023; Piontek et al. 2008; Savadi et al.,2013). In addition, the success rate of smoking cessation initiatives carried out by teachers themselves is low (Tunç, 2007). It is important for teachers to quit smoking not only for their own health but also for setting an example for students, who are the adults of the future.
It has been stated that the reason for the diversity in the effectiveness of investments made to quit smoking all over the world is the differences in the behavioral support provided to individuals (Hartmann et al., 2021). Most non-pharmacological interventions for smoking cessation use the transtheoretic change model defined by Prochaska and DiClemente (Prochaska \& DiClemente, 1992; Ripoll et al, 2012). The transeoretic model is one of the guiding models used to help individuals achieve positive behavioral change. According to this model, a smoker goes through a series of stages in the process of quitting smoking: non-reflection (the individual does not think about quitting smoking), contemplation (the individual begins to feel unhappy with his addiction and begins to think about quitting smoking in the next 6 months), preparation (the individual is ready to quit smoking), action (the individual has not completed six months of quitting smoking), continuation (the individual has not smoked for more than six months (Prochaska et al., 1992). The model is based on the principle that behavioral change is a process and that the interventions are developed according to the stage of change the individual is in ( Taş et al., 2016). When individuals are not ready for behavioral change, the risk of relapse increases (Koyun, 2015). The best form of behavioral change is the one that occurs in stages (Maddux, 1995). Motivational interviewing techniques and counseling training are included in smoking cessation attempts. , web-based interventions, and mobile phone-based interventions have been found effective as smoking cessation methods and are accepted as recommended approaches (Önür et al.2016; Taş et al.,2016; Fang et al,2023; Akdeniz et al.2020; Mermer et al,2016).
Today, mobile technologies are among the effective methods in health promotion and development. On the other hand, the rate of individuals using mobile and smartphones in Turkey in 2023 is 95.4% (Mobisad, 2023). 87.1% of these individuals can access the internet from their mobile devices (TUIK, 2023). Mobile internet interventions allow users to carry the intervention with them during their daily routine (Danaher et al., 2019). Barriers to quitting smoking include limited access and adherence to effective cessation interventions. It is thought that technology can help overcome these obstacles (Iacoviello et al.,2017). Mobile applications can reduce negative health outcomes by providing real-time, permanent and cost-effective support to support tobacco cessation (Chu et al.,2021). In their meta-analysis study investigating e-health-based smoking cessation interventions, Fang et al. (2023) defined the mobile health application as the dominant approach compared to others and stated that it could be an encouraging method for quitting smoking. Iacoviello et al (2017) found that the use of the Clickotine smartphone application to quit smoking may be associated with smoking cessation results. Many other studies have mentioned the effectiveness of mobile technologies in quitting smoking (Baskerville et al., 2018; Crane et al., 2018; Marler et al., 2019; Zhou et al., 2023; Brin et al., 2023; Pandya et al., 2023).
Biochemical confirmations are considered the gold standard in detecting smoking (Fanshawe et al.,2017). While smoking causes the body to absorb various toxins, one of these toxins that can be easily monitored is carbon monoxide (CO). CO assessment is an easy, non-invasive and fast-yielding method (Babaoğlu et al., 2016; Shie et al., 2017). Public health nurses have important roles in protecting and improving health and reducing health risks. In the theme of the International Council of Nurses (ICN (2005), it is stated that nurses have an important opportunity in their daily work routines to protect individuals from smoking and to help users quit smoking (Bilir \& Telatar, 2005). While nurses can provide objective data with CO measurement in the monitoring of the smoking cessation initiative process, Thanks to mobile technology, they can communicate with individuals more easily, increase their motivation, and follow up. Nurses can support individuals to take action in the fight against smoking. In a study, the emergency room nurse used the "Ask, Advise, Refer" method to increase the number of patients with 6.3 cigarettes after a 12-week intervention. It has been reported that many people accept smoking cessation interventions (Simerson \& Hackbarth, 2018). Similarly, in a systematic review, it was stated that smoking cessation interventions made by nurses were effective in helping individuals give up their smoking habits (Petersen et al., 2017).
- Conditions
- Smoking, Mobile Application
- Being tested
- experimental group
- Keywords
- mobile application, smoking, breathing carbon monoxide, self-efficacy
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupOther
The experimental group will be asked to use a mobile smoking cessation application based on the transtheoretical model. Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group will be provided with smoking cessation training based on the transtheoretical model.Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months. Receives: Other: experimental group |
| Control Group | Other | The control group will be given ordinary smoking cessation information. Measurements will be made at 1, 3, and 6 months. Receives: Other: experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fagerstrom Nicotine Dependency Test (FNBT):
It measures the addiction levels of individuals. It was developed by Fagerström in 1989 and consists of 6 questions. The scores that can be obtained from the scale are between 0 and 10.High scores from the scale indicate a high level of nicotine addiction, and low scores indicate a low level of nicotine addiction.
Measured: 1,3,6. months
Secondary outcomes (1)
Self-Efficacy Scale:
In 1985, Diclemente et al. the 2012 version of the scale developed by A.Ş. consists of 8 items and has no subscales. It is a Likert-type scale scored from 1 to 5, and the highest score that can be obtained is 40 and the lowest score is 8. Getting a high score from the scale indicates the will to stop smoking even in situations that encourage the individual to smoke and the success of changing smoking behavior.
Measured: 1,3,6. months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda KUTLU, Ege University
- Investigators
- Gülengül MERMER, Assoc.Prof., Study director, https://unisis.ege.edu.tr/researcher=gulengul.s.mermer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492772
- Sponsor's protocol ID
- 24-6T/16
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mobile Application Developed Against Smoking Behavior on Teachers' Self-Efficacy, Decision Making and Breath Carbon Monoxide Levels
- ClinicalTrials.gov ID
- NCT06492772
- Acronym / sponsor ID
- 24-6T/16
- Conditions
- Smoking, Mobile Application
- Keywords
- mobile application, smoking, breathing carbon monoxide, self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:This research aims to examine the effect of a mobile application developed against smoking behavior on teachers' self-efficacy, decision-making and carbon monoxide levels in breath.The research was planned as a randomized controlled experimental type.Working in public schools in Izmir/Narlıdere District teachers constitute the universe of the research. According to the calculations made, it was decided to include 35 people in the experimental group and 35 people in the control group. After obtaining institutional permissions, teachers who meet the inclusion criteria will be determined.To ensure homogeneity, control and intervention groups will be stratified according to age, gender, and addiction levels.Assignment to intervention and control groups will be made by simple randomization method.The average scores of teachers' self-efficacy, breath carbon monoxide and decision-making levels are the dependent variables of the study.The status of using the mobile application is the independent variable. "Personal Information Form", "Fagerstrom Nicotine Dependency Test (FNBT)", "Self-Efficacy Scale", "Classification of Stages of Change Scale", "Decision Making Scale" and "Carbon Monoxide Measurement Values Tracking Form" will be used in this research. SPSS 26.0 Package program will be used to analyze the data in the study. It will be evaluated statistically at a 95% confidence interval and a significance level of p<0.05. Number and percentage distributions for sociodemographic characteristics will be used in the analysis of the data.In comparisons between groups, parametric or nonparametric tests will be used after evaluating the normal distribution feature of the scale scores.
Hypotheses 1 H1:There is a difference between the breath CO level scores of intervention and control group teachers according to time (pre-test - 1st month, 3rd month and 6th month).
Hypotheses 2 H1:There is a difference between the self-efficacy scale scores of intervention and control group teachers according to time (pre-test, 1st month, 3rd month, 6th month).
Hypotheses 3 H1: There is a difference between the decision-making level scores of teachers in the intervention and control groups according to time (pretest-1st month, 3rd month and 6th month).
Detailed description
Smoking is one of the leading preventable causes of disease. According to global adult tobacco survey data, 19.2 million people (31.6%) in Turkey use tobacco products (KYTA, 2016). The rate of individuals over the age of 15 who use tobacco products every day is announced as 28.3% in TUIK 2022 data. Smoking rates of teachers were found to be between 29.1 and 52.4% in studies conducted in Turkey (Perincek, 2021). Teachers are the most important exemplary community in the school, with their identity as educators and their function as role models in society. Teachers with nicotine addiction must smoke during school hours.However, there is a negative relationship between teachers' desire to smoke and their personal success (Becet A.,2019). In a study, it was stated that transtheoretic model-based education increased teachers' anti-smoking attitudes and reduced nicotine addiction (Mermer et al. 2016). Studies indicate that the presence of teachers who smoke at school is associated with students' smoking behavior (Radha et al.,2019; Kjeld et al.,2023; Piontek et al. 2008; Savadi et al.,2013). In addition, the success rate of smoking cessation initiatives carried out by teachers themselves is low (Tunç, 2007). It is important for teachers to quit smoking not only for their own health but also for setting an example for students, who are the adults of the future.
It has been stated that the reason for the diversity in the effectiveness of investments made to quit smoking all over the world is the differences in the behavioral support provided to individuals (Hartmann et al., 2021). Most non-pharmacological interventions for smoking cessation use the transtheoretic change model defined by Prochaska and DiClemente (Prochaska \& DiClemente, 1992; Ripoll et al, 2012). The transeoretic model is one of the guiding models used to help individuals achieve positive behavioral change. According to this model, a smoker goes through a series of stages in the process of quitting smoking: non-reflection (the individual does not think about quitting smoking), contemplation (the individual begins to feel unhappy with his addiction and begins to think about quitting smoking in the next 6 months), preparation (the individual is ready to quit smoking), action (the individual has not completed six months of quitting smoking), continuation (the individual has not smoked for more than six months (Prochaska et al., 1992). The model is based on the principle that behavioral change is a process and that the interventions are developed according to the stage of change the individual is in ( Taş et al., 2016). When individuals are not ready for behavioral change, the risk of relapse increases (Koyun, 2015). The best form of behavioral change is the one that occurs in stages (Maddux, 1995). Motivational interviewing techniques and counseling training are included in smoking cessation attempts. , web-based interventions, and mobile phone-based interventions have been found effective as smoking cessation methods and are accepted as recommended approaches (Önür et al.2016; Taş et al.,2016; Fang et al,2023; Akdeniz et al.2020; Mermer et al,2016).
Today, mobile technologies are among the effective methods in health promotion and development. On the other hand, the rate of individuals using mobile and smartphones in Turkey in 2023 is 95.4% (Mobisad, 2023). 87.1% of these individuals can access the internet from their mobile devices (TUIK, 2023). Mobile internet interventions allow users to carry the intervention with them during their daily routine (Danaher et al., 2019). Barriers to quitting smoking include limited access and adherence to effective cessation interventions. It is thought that technology can help overcome these obstacles (Iacoviello et al.,2017). Mobile applications can reduce negative health outcomes by providing real-time, permanent and cost-effective support to support tobacco cessation (Chu et al.,2021). In their meta-analysis study investigating e-health-based smoking cessation interventions, Fang et al. (2023) defined the mobile health application as the dominant approach compared to others and stated that it could be an encouraging method for quitting smoking. Iacoviello et al (2017) found that the use of the Clickotine smartphone application to quit smoking may be associated with smoking cessation results. Many other studies have mentioned the effectiveness of mobile technologies in quitting smoking (Baskerville et al., 2018; Crane et al., 2018; Marler et al., 2019; Zhou et al., 2023; Brin et al., 2023; Pandya et al., 2023).
Biochemical confirmations are considered the gold standard in detecting smoking (Fanshawe et al.,2017). While smoking causes the body to absorb various toxins, one of these toxins that can be easily monitored is carbon monoxide (CO). CO assessment is an easy, non-invasive and fast-yielding method (Babaoğlu et al., 2016; Shie et al., 2017). Public health nurses have important roles in protecting and improving health and reducing health risks. In the theme of the International Council of Nurses (ICN (2005), it is stated that nurses have an important opportunity in their daily work routines to protect individuals from smoking and to help users quit smoking (Bilir \& Telatar, 2005). While nurses can provide objective data with CO measurement in the monitoring of the smoking cessation initiative process, Thanks to mobile technology, they can communicate with individuals more easily, increase their motivation, and follow up. Nurses can support individuals to take action in the fight against smoking. In a study, the emergency room nurse used the "Ask, Advise, Refer" method to increase the number of patients with 6.3 cigarettes after a 12-week intervention. It has been reported that many people accept smoking cessation interventions (Simerson \& Hackbarth, 2018). Similarly, in a systematic review, it was stated that smoking cessation interventions made by nurses were effective in helping individuals give up their smoking habits (Petersen et al., 2017).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: experimental groupThe experimental group will be provided with smoking cessation training based on the transtheoretical model.Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months. |
| Control Group | Other | Other: experimental groupThe control group will be given ordinary smoking cessation information. Measurements will be made at 1, 3, and 6 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having a smartphone and daily internet access
- Volunteering to participate in the study
- Getting a score of 5 medium level or above according to the Fagerström Nicotine Dependency Test rules test
- Not always having any smoking cessation support or a smoking cessation intervention
Key exclusion criteria (5 listed)
- Those who did not agree to participate in the research
- Those who do not smoke or have quit smoking
- Those who use any tobacco product other than cigarettes (e-cigarette, hookah, cigar, etc.)
- Those who have severe chronic health problems (vision-hearing problems, dementia and Alzheimer's, chronic lung diseases)
- Those who do not use smartphones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupThe experimental group will be asked to use a mobile smoking cessation application based on the transtheoretical model. Individuals will be required to use the mobile application for 6 months. Measurements will be made at 1, 3, and 6 months. | Other | Control Group, Experimental Group |
Primary outcome
Fagerstrom Nicotine Dependency Test (FNBT):
Time frame: 1,3,6. months
It measures the addiction levels of individuals. It was developed by Fagerström in 1989 and consists of 6 questions. The scores that can be obtained from the scale are between 0 and 10.High scores from the scale indicate a high level of nicotine addiction, and low scores indicate a low level of nicotine addiction.
1 secondary outcome
Self-Efficacy Scale:
Time frame: 1,3,6. months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülengül MERMER, Assoc.Prof. study director
https://unisis.ege.edu.tr/researcher=gulengul.s.mermer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group in people with Smoking and Mobile Application, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seda KUTLU, PhD Student (+905412590972, 93210000114@ogrenci.ege.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerstrom Nicotine Dependency Test (FNBT): (time frame: 1,3,6. months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.