Smoking CessationNCT05173428
The Effect of Motivational Interviews Based on the Transtheoretic Model on Pregnant Women's Smoking Cessation Behaviors
A study testing Smoking Cessation Program Based on Transtheoretic Model in people with Smoking Cessation and Smoking, Tobacco, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
This study is planned to determine the effect of online motivational interviews based on the transtheoretic model on the prediction of smoking cessation success, self-efficacy levels and smoking cessation behavior of pregnant women.It is an experimental research. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation, Smoking, Tobacco
- What is being tested?
- Smoking Cessation Program Based on Transtheoretic Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2021to 30 Nov 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research
- Not completing the 16th week of pregnancy
- Being 18 years or older
- To smoke at least 1 cigarette a day
- Being able to use a smart phone or computer and having internet
- Being literate
Who cannot join
- Unable to use a computer or smartphone
- Being at the 17th and above gestational week
- Having any mental illness
- Illiterate pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Online Motivational Interviews Based on the Transtheoretical Model on Pregnant Women's Prediction of Smoking Cessation Success, Self-Efficacy Levels and Smoking Cessation Behaviors
This study is planned to determine the effect of online motivational interviews based on the transtheoretic model on the prediction of smoking cessation success, self-efficacy levels and smoking cessation behavior of pregnant women.It is an experimental research.
Read the detailed description
The population of the research will be the pregnant women registered in the family health center in Sivas city center.The sample of the study will consist of pregnant women who smoke and agree to participate in the study.Power analysis was calculated using G * Power 3.1.9.2 program. With 76% effect size, 90% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 66 individuals, 33 individuals in the intervention group and 33 individuals in the control group, by taking 10% more of the calculated sample against the possibility of sample loss during the study.Smoking Cessation Success Prediction Scale Self-Efficacy Level Scale Decision-Making Balance Scale Behavior Change Stage Diagnostic Questionnaire Fagerström Nicotine Addiction Test will be used as measurement tools.Pregnant women who agree to participate in the study will fill in the Informed Consent Form and other measurement tools.Interviews with the pregnant women in the intervention group will be held face-to-face via the Zoom application for a total of 6 times.Data collection forms will be applied to the control group at the first interview and at the last interview (6 months later), and for the intervention group at the first interview, 3 months and 6 months later, a total of 3 times.After each assessment moment, the data obtained will be exported to the "Statistical Package for Social Sciences Software" (SPSS).
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Being tested
- Smoking Cessation Program Based on Transtheoretic Model
- Keywords
- Motivational Interviews, Transtheoretic Model, Pregnancy
- Medical subject headings
- Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Program Based on Transtheoretic ModelBehavioural
Conducting motivational interviews based on the transtheoretic model according to the stages of change that individuals are in.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Gruop | Experimental | Online motivational interviews based on the transtheoretic model with the intervention group will be held via zoom. Data collection forms will be applied to the intervention group at the first interview, at the 3rd month as an interim monitoring, and at the 6th month as the final monitoring. Receives: Behavioral: Smoking Cessation Program Based on Transtheoretic Model |
| Control Gruop | No intervention | No intervention will be made to the control group, and data collection forms will be applied at the first interview and 6 months after the first interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking-Cessation Success Prediction Scale
The scale consists of 10 items.Items in the scale are evaluated with a 5-point Likert scale (1: too little, 2: little, 3: middle, 4: a little too much, 5: much).The maximum score that can be obtained from the scale is 50, and the minimum score is 10. Scale score indicates that the success of smoking cessation will be high.
Measured: 6 months
Decisional Balance Scale
The scale, which has 24 items, consists of two sub-dimensions: "Positive aspects of smoking" and "Negative aspects of smoking". Each item of the scale is scored from 1 to 5 as 1- I strongly disagree, 2- I do not agree, 3- I neither agree nor disagree, 4- I agree, 5- I completely agree.For both sub-dimensions, the minimum score that can be obtained from the scale is 12, and the maximum score is 60.Scale total score; It is calculated by subtracting the perceived harm total score of smoking from the total perceived benefit score of smoking. The negative (-) result indicates that the perceived harms of smoking are dominant in the decision-making balance. The positive (+) result indicates that the perceived benefits of smoking are dominant in the decision-making balance.
Measured: 6 months
Self-Efficacy Level Scale
The scale consists of 23 items and 4 sub-dimensions: starting the behavior, maintaining the behavior, completing the behavior and struggling with obstacles.For each item in the scale; 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well.A minimum of 23 and a maximum of 115 points can be obtained from the scale. The high total score obtained from the scale indicates that the general self-efficacy perception is high.
Measured: 6 months
Fagerstrom Test For Nicotine Dependence
The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
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 posted30 Dec 2021
- Study start30 Dec 2021
- Primary completion30 Jul 2022
- Study completion30 Nov 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betul Esra Cevik, Cumhuriyet University
- Investigators
- Semra ZORLU, PhD, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173428
- Sponsor's protocol ID
- SCU-BECEVIK-001
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2021
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Online Motivational Interviews Based on the Transtheoretical Model on Pregnant Women's Prediction of Smoking Cessation Success, Self-Efficacy Levels and Smoking Cessation Behaviors
- ClinicalTrials.gov ID
- NCT05173428
- Acronym / sponsor ID
- SCU-BECEVIK-001
- Conditions
- Smoking Cessation, Smoking, Tobacco
- Keywords
- Motivational Interviews, Transtheoretic Model, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 30 Dec 2021 (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.
This study is planned to determine the effect of online motivational interviews based on the transtheoretic model on the prediction of smoking cessation success, self-efficacy levels and smoking cessation behavior of pregnant women.It is an experimental research.
Detailed description
The population of the research will be the pregnant women registered in the family health center in Sivas city center.The sample of the study will consist of pregnant women who smoke and agree to participate in the study.Power analysis was calculated using G * Power 3.1.9.2 program. With 76% effect size, 90% power and 0.05 significance level, the required sample size was determined as 30 individuals per group, and 60 individuals in total. It was decided to include 66 individuals, 33 individuals in the intervention group and 33 individuals in the control group, by taking 10% more of the calculated sample against the possibility of sample loss during the study.Smoking Cessation Success Prediction Scale Self-Efficacy Level Scale Decision-Making Balance Scale Behavior Change Stage Diagnostic Questionnaire Fagerström Nicotine Addiction Test will be used as measurement tools.Pregnant women who agree to participate in the study will fill in the Informed Consent Form and other measurement tools.Interviews with the pregnant women in the intervention group will be held face-to-face via the Zoom application for a total of 6 times.Data collection forms will be applied to the control group at the first interview and at the last interview (6 months later), and for the intervention group at the first interview, 3 months and 6 months later, a total of 3 times.After each assessment moment, the data obtained will be exported to the "Statistical Package for Social Sciences Software" (SPSS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Gruop | Experimental | Behavioral: Smoking Cessation Program Based on Transtheoretic ModelOnline motivational interviews based on the transtheoretic model with the intervention group will be held via zoom. Data collection forms will be applied to the intervention group at the first interview, at the 3rd month as an interim monitoring, and at the 6th month as the final monitoring. |
| Control Gruop | No intervention | –No intervention will be made to the control group, and data collection forms will be applied at the first interview and 6 months after the first interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Volunteering to participate in the research
- Not completing the 16th week of pregnancy
- Being 18 years or older
- To smoke at least 1 cigarette a day
- Being able to use a smart phone or computer and having internet
Key exclusion criteria (4 listed)
- Unable to use a computer or smartphone
- Being at the 17th and above gestational week
- Having any mental illness
- Illiterate pregnant women
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 |
|---|---|---|
| Smoking Cessation Program Based on Transtheoretic ModelConducting motivational interviews based on the transtheoretic model according to the stages of change that individuals are in. | Behavioural | Interventional Gruop |
Primary outcome
Smoking-Cessation Success Prediction Scale
Time frame: 6 months
The scale consists of 10 items.Items in the scale are evaluated with a 5-point Likert scale (1: too little, 2: little, 3: middle, 4: a little too much, 5: much).The maximum score that can be obtained from the scale is 50, and the minimum score is 10. Scale score indicates that the success of smoking cessation will be high.
Decisional Balance Scale
Time frame: 6 months
The scale, which has 24 items, consists of two sub-dimensions: "Positive aspects of smoking" and "Negative aspects of smoking". Each item of the scale is scored from 1 to 5 as 1- I strongly disagree, 2- I do not agree, 3- I neither agree nor disagree, 4- I agree, 5- I completely agree.For both sub-dimensions, the minimum score that can be obtained from the scale is 12, and the maximum score is 60.Scale total score; It is calculated by subtracting the perceived harm total score of smoking from the total perceived benefit score of smoking. The negative (-) result indicates that the perceived harms of smoking are dominant in the decision-making balance. The positive (+) result indicates that the perceived benefits of smoking are dominant in the decision-making balance.
Self-Efficacy Level Scale
Time frame: 6 months
The scale consists of 23 items and 4 sub-dimensions: starting the behavior, maintaining the behavior, completing the behavior and struggling with obstacles.For each item in the scale; 1-Does not describe me at all, 2-Describes me a little, 3-I am undecided, 4-Describes me well, 5-Describes me very well.A minimum of 23 and a maximum of 115 points can be obtained from the scale. The high total score obtained from the scale indicates that the general self-efficacy perception is high.
Fagerstrom Test For Nicotine Dependence
Time frame: 6 months
The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.
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 10 Feb 2023.
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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.
Semra ZORLU, PhD study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Program Based on Transtheoretic Model in people with Smoking Cessation and Smoking, Tobacco, run by Cumhuriyet 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 6 inclusion and 4 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 10 Feb 2023. 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?
Smoking-Cessation Success Prediction Scale (time frame: 6 months). The study lists 4 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 10 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.