Smoking CessationNCT05314894
The Effect of the Education Program Based on the PRECEDE-PROCEED Model on the Smoking Behaviors of Nursing Students
A study testing Education in people with Smoking Cessation, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The causes of death due to smoking are responsible for 11.5% of the total deaths in the world. Smoking causes lung cancer, chronic obstructive pulmonary disease (COPD), ischemic heart disease and cerebrovascular diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2021to 1 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Approving to participate in the study,
- Smoker (according to WHO, a person who smokes at least one cigarette per day),
- According to the Fagerström Test for Nicotine Dependence, nicotine addiction is at least "very low" or higher*,
- Not having any communication barriers to participate in the study,
- Those who are in the stages of "thinking" and "preparation" of the stages of change according to the Classification of Stages of Change Scale for smoking cessation**,
- Not taking any smoking cessation treatment at the time of the study,
- Having a smart mobile phone and using the WhatsApp program,
- Consists of students who have not received training in smoking cessation before
Who cannot join
- Non-smokers
- Those who do not plan to quit smoking (those who are at the stage of "not thinking" according to the Classification of Stages of Change Scale)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Program Based on the PRECED-PROCEED Model "I am Giving up Smoking, I am Protecting My Future and My Health" on Smoking Behaviour of Nursing Students
The causes of death due to smoking are responsible for 11.5% of the total deaths in the world. Smoking causes lung cancer, chronic obstructive pulmonary disease (COPD), ischemic heart disease and cerebrovascular diseases. In some studies on nursing students in the world, the prevalence of smoking is between 13.9% and 32%; It is known that it varies between 12.9% and 28% in Turkey. At the end of this study, nursing students are supported in smoking cessation by providing smoking cessation training, they become a role model for the society by gaining the right behavior, creating a society that smokes less, reducing the financial burden on the state as a result of protecting individuals from possible chronic diseases, and guiding health trainings on this subject. It is foreseen that it will be a guide in its implementation in the whole country. The aim of this study is to determine the effect of the I Stop Smoking, Protecting My Future and Health program based on the Preced-Proceed Model on the smoking behavior of nursing students.
Read the detailed description
This study will be conducted in non-randomized groups in a quasi-experimental fashion as pre-test-post-test.
The population of the research was formed by the students in the Nursing Department of the Faculty of Health Sciences of Kırşehir Ahi Evran University. There are two branches of daytime education and two branches of secondary education, and the total number of students in the nursing department is 802. The sample size of the study was calculated using the G*Power (v3.1.9.6) package program. The power of the study was 80% and the sample size was α =0.05; It was calculated as a total of 64 people, 32 of which were interventions and 32 were control groups. However, considering the losses, 20% more than the calculated value was included in the sample and it was planned to include a total of 80 students, 40 of whom were in the intervention group and 40 in the control group.
Selection and Assignment of Individuals to the Intervention and Control Group Before being divided into intervention and control groups, students' consent was obtained and a pre-test was applied. Formal education and secondary education students were coded as A and B. For example, formal education A, secondary education B. The students in the related group were stratified by gender and the layer weight was determined. Random numbers were created in the Excel program and it was determined who would be in the groups with the simple random sampling method. In addition, which of the previously coded groups A and B would be the intervention group and which one would be the control group was determined by drawing lots. All these procedures were carried out by a person other than the researcher. Thus, it was determined who would be in the intervention and control group, and it was explained to the researcher before the training whether group A or group B was the intervention or control group.
Dependent variables:
- Behavior modification level
- Decision equilibrium level
- Self-efficacy level
- Level of encouraging factors
- Level of stages of change
- Number of people who quit smoking
- Nicotine addiction level
- Health perception level
Independent variables:
"I Stop Smoking, I Protect My Future and My Health" program based on the PRECEDE-PROCEED Model.
As data collection tools; Smoker identification form, individual information form, Behavior change process scale, Decision balance scale, Self-efficacy scale, Encouraging factors scale, Classification of stages of change scale, Fagerström nicotine addiction test will be used. The data were also planned to be collected in this environment before the first training (pretest), and after the second and third training (posttest). The first session will be held immediately after the pre-test, the second session will be held 15 days after the first session, and the last session will be held 15 days after the second session. A total of 40 messages will be sent to the students in the initiative group through the WhatsApp program, taking into account the factors that affect, strengthen and enable the main
- Conditions
- Smoking Cessation
- Being tested
- Education
- Keywords
- Nursing Students, Stopping Smoking
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Giving training to the students in the initiative group to quit smoking in three sessions, sending messages via whatsapp program and telephone counseling
| Study group | Role | What they receive |
|---|---|---|
| initiative group | Experimental | The first session will be right after the pre-test, the second session will be 15 days after the first session, and the last session will be 15 days after the second session. After the training is over, a total of 40 messages will be sent to the students in the initiative group, taking into account the factors that affect, strengthen and activate the main communication via the WhatsApp program. Receives: Behavioral: Education |
| control group | No intervention | No intervention will be made |
What is being measured
The primary outcome is the main question the study is designed to answer.
It is expected that the students in the intervention group will be more likely to quit smoking than the students in the control group.
Determining the number of non-smokers, unit of measure: frequency, scale of stages of change, Individual information form
Measured: 6 months
The level of nicotine addiction in the intervention group is expected to be lower than in the control group.
Measuring nicotine addiction, unit of measure: nicotine addiction level, Fagerström Test for Nicotine Dependence
Measured: 6 months
Secondary outcomes (5)
The level of behavior change is expected to be higher in the intervention group than in the control group.
Measuring behavior change, comparison of scale tools between groups. Name of the scale: Behavior Change Processes Scale. A maximum of 110 and a minimum of 22 points are obtained from the scale. A high score on this scale is interpreted as a high chance of success in behavior change, and a low score is interpreted as a low chance of success.
Measured: 6 months
It is expected that there will be a higher level of decision balance in the intervention group than in the control group.
Measurement decision balance, Comparison of scale averages between groups. Name of the scale: Decision Balance Scale. The scale consists of 12 questions about the negative aspects of smoking and 12 questions about the positive aspects of smoking. The total score of the scale is calculated by subtracting the perceived harm total score from the perceived benefit total score of smoking, and a negative (-) result indicates that the perceived harms of smoking dominate in the decision balance and a positive (+) result. shows that the perceived benefits of smoking are more in the decision balance. A minimum of 12 and a maximum of 60 points can be obtained for both sub-dimensions. A high score on the questions about the positive aspects of smoking indicates that he is undecided in changing behavior, and a high score on the negative aspects indicates that he is determined to change and maintain the behavior.
Measured: 6 months
Higher self-efficacy/efficacy levels are expected in the intervention group compared to the control group.
Comparing the scale averages between groups, measuring the level of self-efficacy. Name of the Scale: Self-Efficacy Scale. Maximum 40 and minimum 8 points are taken from the scale. A high score on the scale reveals the success of not smoking even if there are encouraging factors.
Measured: 6 months
The incentive factor level is expected to be lower in the intervention group than in the control group.
Measuring the level of incentive factor, Comparing the scale averages between groups. Name of the scale: Encouragement Factor Scale. A maximum of 40 and a minimum of 8 points can be obtained from the scale. Getting a high score from the scale; Indicates low power to stop smoking despite situations that encourage smoking
Measured: 6 months
A higher level of positive health perception is expected in the intervention group than in the control group.
Measuring health perception, More positive health perception in the intervention group compared to the control group, unit of measure: frequency. Individuals are asked a question about how they perceive their health. Results will be compared with frequency in the intervention and control groups.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Oct 2021
- Primary completion1 Nov 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdal Akdeniz, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314894
- Sponsor's protocol ID
- AhiEvranU_EAkdeniz_001
- Status last verified
- Apr 2022
- First submitted
- 1 Jan 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Program Based on the PRECED-PROCEED Model "I am Giving up Smoking, I am Protecting My Future and My Health" on Smoking Behaviour of Nursing Students
- ClinicalTrials.gov ID
- NCT05314894
- Acronym / sponsor ID
- AhiEvranU_EAkdeniz_001
- Conditions
- Smoking Cessation
- Keywords
- Nursing Students, Stopping Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 6 Apr 2022 (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.
The causes of death due to smoking are responsible for 11.5% of the total deaths in the world. Smoking causes lung cancer, chronic obstructive pulmonary disease (COPD), ischemic heart disease and cerebrovascular diseases. In some studies on nursing students in the world, the prevalence of smoking is between 13.9% and 32%; It is known that it varies between 12.9% and 28% in Turkey. At the end of this study, nursing students are supported in smoking cessation by providing smoking cessation training, they become a role model for the society by gaining the right behavior, creating a society that smokes less, reducing the financial burden on the state as a result of protecting individuals from possible chronic diseases, and guiding health trainings on this subject. It is foreseen that it will be a guide in its implementation in the whole country. The aim of this study is to determine the effect of the I Stop Smoking, Protecting My Future and Health program based on the Preced-Proceed Model on the smoking behavior of nursing students.
Detailed description
This study will be conducted in non-randomized groups in a quasi-experimental fashion as pre-test-post-test.
The population of the research was formed by the students in the Nursing Department of the Faculty of Health Sciences of Kırşehir Ahi Evran University. There are two branches of daytime education and two branches of secondary education, and the total number of students in the nursing department is 802. The sample size of the study was calculated using the G*Power (v3.1.9.6) package program. The power of the study was 80% and the sample size was α =0.05; It was calculated as a total of 64 people, 32 of which were interventions and 32 were control groups. However, considering the losses, 20% more than the calculated value was included in the sample and it was planned to include a total of 80 students, 40 of whom were in the intervention group and 40 in the control group.
Selection and Assignment of Individuals to the Intervention and Control Group Before being divided into intervention and control groups, students' consent was obtained and a pre-test was applied. Formal education and secondary education students were coded as A and B. For example, formal education A, secondary education B. The students in the related group were stratified by gender and the layer weight was determined. Random numbers were created in the Excel program and it was determined who would be in the groups with the simple random sampling method. In addition, which of the previously coded groups A and B would be the intervention group and which one would be the control group was determined by drawing lots. All these procedures were carried out by a person other than the researcher. Thus, it was determined who would be in the intervention and control group, and it was explained to the researcher before the training whether group A or group B was the intervention or control group.
Dependent variables:
- Behavior modification level
- Decision equilibrium level
- Self-efficacy level
- Level of encouraging factors
- Level of stages of change
- Number of people who quit smoking
- Nicotine addiction level
- Health perception level
Independent variables:
"I Stop Smoking, I Protect My Future and My Health" program based on the PRECEDE-PROCEED Model.
As data collection tools; Smoker identification form, individual information form, Behavior change process scale, Decision balance scale, Self-efficacy scale, Encouraging factors scale, Classification of stages of change scale, Fagerström nicotine addiction test will be used. The data were also planned to be collected in this environment before the first training (pretest), and after the second and third training (posttest). The first session will be held immediately after the pre-test, the second session will be held 15 days after the first session, and the last session will be held 15 days after the second session. A total of 40 messages will be sent to the students in the initiative group through the WhatsApp program, taking into account the factors that affect, strengthen and enable the main
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| initiative group | Experimental | Behavioral: EducationThe first session will be right after the pre-test, the second session will be 15 days after the first session, and the last session will be 15 days after the second session. After the training is over, a total of 40 messages will be sent to the students in the initiative group, taking into account the factors that affect, strengthen and activate the main communication via the WhatsApp program. |
| control group | No intervention | –No intervention will be made |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Approving to participate in the study,
- Smoker (according to WHO, a person who smokes at least one cigarette per day),
- According to the Fagerström Test for Nicotine Dependence, nicotine addiction is at least "very low" or higher*,
- Not having any communication barriers to participate in the study,
- Those who are in the stages of "thinking" and "preparation" of the stages of change according to the Classification of Stages of Change Scale for smoking cessation**,
Key exclusion criteria (2 listed)
- Non-smokers
- Those who do not plan to quit smoking (those who are at the stage of "not thinking" according to the Classification of Stages of Change Scale)
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 |
|---|---|---|
| EducationGiving training to the students in the initiative group to quit smoking in three sessions, sending messages via whatsapp program and telephone counseling | Behavioural | initiative group |
Primary outcome
It is expected that the students in the intervention group will be more likely to quit smoking than the students in the control group.
Time frame: 6 months
Determining the number of non-smokers, unit of measure: frequency, scale of stages of change, Individual information form
The level of nicotine addiction in the intervention group is expected to be lower than in the control group.
Time frame: 6 months
Measuring nicotine addiction, unit of measure: nicotine addiction level, Fagerström Test for Nicotine Dependence
5 secondary outcomes
The level of behavior change is expected to be higher in the intervention group than in the control group.
Time frame: 6 months
It is expected that there will be a higher level of decision balance in the intervention group than in the control group.
Time frame: 6 months
Higher self-efficacy/efficacy levels are expected in the intervention group compared to the control group.
Time frame: 6 months
The incentive factor level is expected to be lower in the intervention group than in the control group.
Time frame: 6 months
A higher level of positive health perception is expected in the intervention group than in the control group.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Smoking Behaviors
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Smoking Cessation, run by Kirsehir Ahi Evran Universitesi 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 6 Apr 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
It is expected that the students in the intervention group will be more likely to quit smoking than the students in the control group. (time frame: 6 months). The study lists 2 primary outcomes in all. 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 6 Apr 2022.