Postpartum Smoking RelapseNCT05711225
Transtheoretic Model, Postpartum Smoking Relapse, Smoking Cessation Intervention
A study testing smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse. in people with Postpartum Smoking Relapse, run by Semra YILMAZ at 1 site in Turkey (Türkiye).
Trial summary
The postpartum period is an important opportunity to improve maternal and fetal health by preventing smoking relapse in women. To achieve this goal, digital platforms, which are the latest technological developments are used. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Smoking Relapse
- What is being tested?
- smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Mar 2021to 1 Dec 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
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Don't have a smartphone
- Having the ability to use the Internet
- 32nd gestational week and below
- Reporting smoking at least two cigarettes per day in the 3 months before conception
Who cannot join
- Not watching videos within the scope of web-based intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Smoking Cessation Intervention in Pregnancy According to the Web-Based Transtheoretic Model on Postpartum Smoking Relapse
The postpartum period is an important opportunity to improve maternal and fetal health by preventing smoking relapse in women. To achieve this goal, digital platforms, which are the latest technological developments are used. However, studies using digital platforms on smoking cessation and postpartum smoking relapse in pregnant women are limited in this area. The research was carried out to determine the effect of smoking cessation intervention prepared in line with the transtheoretic model on the digital platform, on preventing smoking relapse in the postpartum period. As a result of the research, it is thought that nurses will guide their professional practices with an evidence-based up-to-date approach.
Read the detailed description
Smoking during pregnancy is the most important cause of preventable complications. Smoking has many negative effects on fetal development and well-being as well as women's health. Pregnancy and childbirth can motivate women to quit smoking. However, it is stated that the rate of failure to quit smoking is higher in women than in men, and the period of resumption of smoking is shorter after an attempt to quit. In a large-scale study conducted in 54 low- and middle-income countries, it is stated that the prevalence of any tobacco use during pregnancy is 2.6%, with the highest prevalence being 15% in Turkey. The rates of smoking during pregnancy differ in studies conducted in our country. Due to the stigma and blame for smoking, many women report not smoking during pregnancy. This situation may prevent the exact number of pregnant women who smoke and prevent smoking cessation intervention and treatment. In our country, the rate of smoking during pregnancy was determined as 11.9% by Tarhan and Yılmaz, and as 13% by Dilcen et al. Smoking during pregnancy has numerous adverse effects on the mother and fetus. Intrauterine growth retardation, low birth weight, placenta previa and abruption, premature rupture of membranes, perinatal mortality during pregnancy; For newborns, the risk of developing asthma disease, infantile colic, obesity and sudden infant death are among the negative effects of maternal smoking. Factors affecting smoking during pregnancy were determined as planned pregnancy, number of pregnancies, gestational week, number of living children, frequency of receiving prenatal care, smoking status of the spouse and passive smoking.
It has been reported that women continue to smoke in the postpartum period despite quitting during pregnancy. In a meta-analysis study, it was shown that 43% of women who quit smoking during pregnancy started smoking again in the postpartum 6th month. It is stated that women continue to smoke after birth because they believe that they can no longer have a direct effect on their children. It has been reported that this situation may be related to smoking, postpartum fatigue, and stress related to child care. In addition, it has been shown that resumption of smoking after birth is associated with various factors such as young age, smoking status of people around, low income, and early cessation of breastfeeding. For this reason, it is stated that smoking in women is a complex phenomenon that can be affected by specific experiences related to social relations, pregnancy and birth, and this may cause an increase in postpartum relapse rates in women who quit smoking during pregnancy.
When interventions that support smoking cessation and prevention of relapse from pregnancy to postpartum are evaluated, it is stated that pregnancy is a trigger for smoking cessation and this period should be seen as an opportunity for smoking cessation interventions. Different intervention methods are used to quit smoking. Cessation interventions include informing, cognitive and behavioral treatments, hypnosis, acupuncture, and pharmacological treatments. There is insufficient evidence regarding the efficacy and safety of nicotine replacement, which is one of the pharmacological treatments used in smoking cessation during pregnancy. Instead, other interventions that are effective in quitting smoking during pregnancy; consultancy, feedback, financial incentives, telephone support programs, digital platforms and similar applications can be used. Digital interventions, including mobile health interventions, are considered an innovative way to provide evidence-based smoking cessation support to a hard-to-reach population. The use of digital platforms, including telephone, video, websites or mobile application technologies, can be used effectively to quit smoking during pregnancy. In their study, Derksen et al. found that social networks had a positive effect on the attitudes of pregnant women towards smoking cessation. Dascal et al., in their study to prevent postpartum smoking relapse, found that digital smoking cessation intervention had a positive effect on preventing postpartum smoking.
- Conditions
- Postpartum Smoking Relapse
- Being tested
- smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.
- Keywords
- Transtheoretical Model, Web-based smoking cessation intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.Behavioural
Smoking cessation videos prepared according to the Web-Based Transtheoretic model A module was created on the web, with 5 sections, prepared by the researcher according to the Web-Based Transtheoretic model, for quitting smoking or for pregnant women who quit smoking to maintain this behavior. The modules are prepared in the form of animated videos in which the researcher is educational. Each module is arranged for an average of 5-10 minutes. Theoretical information about the content has been added under each video.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the pregnant women in the experimental group. The pre-test data from the women in the experimental group were obtained through the website through the Participant Introduction Form,"Behavior Change Process Scale" (BCPS), "Self-Efficacy Scale/Encouraging Factors Scale" (SES/EFS) and "Decision Balance Scale" (DBS) before watching the videos. In addition, FNDT was applied to women who smoked during pregnancy. Post-test data from the women in the experimental group were collected by having them fill out the postpartum part of the Participant Identification Form at the 4th week postpartum after watching the animation videos, and FNDT, SCS, BCPS/EFS and DBS forms for those who still smoke, on the website. Receives: Behavioral: smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse. |
| Control group | No intervention | The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the women participating in the control group. The pre-test data of the women participating in the control group were applied via the Participant Identification Form, FNDT, SCS, BCPS/EFS and DBS and the FNDT form to those who continued to smoke during pregnancy. Post-test data from women in the control group were collected with the postpartum part of the Participant Identification Form at 4 weeks postpartum, FNDT, SCS, BCPS/EFS and DBS for smokers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure 1- The Fagerström Test for Nicotine Dependence
The Fagerström Test for Nicotine Dependence was developed to determine the level of addiction to cigarettes.The scores that can be obtained from the scale range from 0 to 10. As addiction to cigarette increases, the score obtained from the scale increases.
it was determined that the mean score of the scale decreased and the level of addiction decreased in the intervention group.
Measured: 15 months
Measure 2- Behavior Change Process Scale
It reveals what processes the individual has experienced in the stages of behavior change.The lowest score that can be obtained from the scale is 22, and the highest is 110. The higher the score obtained from the scale, the higher the chance of success in changing behavior. The higher the score obtained from the scale, the higher the chance of success in changing behavior.
It was determined that women in the intervention group had a higher chance of success in changing their smoking behavior.
Measured: 15 months
Measure 3-Self-Efficacy Scale/Encouraging Factors Scale
The Self-Efficacy Scale/Encouraging Factors Scale shows the confidence that individuals have in order not to return to the harmful behavior they have changed when faced with difficult situations. The lowest score that can be obtained from the scale is 8 and the highest 40. A high score on the self-efficacy scale reveals the success of not smoking and quitting smoking despite encouraging factors. A high score on the Encouraging Factors Scale indicates that the probability of returning to the harmful behavior is high. The Encouraging Factors Scale is used with an answer format that is the opposite of the Self-Efficacy Scale.
Despite the fact that the women in the intervention group faced stimulant situations, not returning to smoking behavior again shows that the power to resist is high.
Measured: 15 months
Measure 4-Decision Balance Scale
The decision balance scale reveals the positive and negative perceptions of behavior change. The scale consists of two sub-dimensions that reveal the perception of the positive and negative aspects of smoking. The lowest score that can be obtained for the two sub-dimensions of the scale is 12, and the highest score is 60. A high score on the benefit (positive) sub-dimension indicates his indecision about changing behavior, while a high score on the harm (negative) sub-dimension indicates that has a higher chance of making and continuing a decision on behavior change.
It was determined that women in the intervention group were more determined to change their smoking behavior and were more likely to maintain this determination.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start24 Mar 2021
- Primary completion1 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Postpartum Smoking RelapseStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The research was conducted as a pretest-posttest control group experimental model.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semra YILMAZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Semra YILMAZ, Adiyaman University
- Investigators
- SEMRA YILMAZ, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711225
- Sponsor's protocol ID
- SYILMAZ
- Status last verified
- Jan 2023
- First submitted
- 12 Dec 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.
PubMed 22145828Lanting CI, van Wouwe JP, van den Burg I, Segaar D, van der Pal-de Bruin KM. [Smoking during pregnancy: trends between 2001 and 2010]. Ned Tijdschr Geneeskd. 2012;156(46):A5092. Dutch.
PubMed 23151329Lange S, Probst C, Rehm J, Popova S. National, regional, and global prevalence of smoking during pregnancy in the general population: a systematic review and meta-analysis. Lancet Glob Health. 2018 Jul;6(7):e769-e776. doi: 10.1016/S2214-109X(18)30223-7. Epub 2018 May 31.
PubMed 29859815Scheffers-van Schayck T, Tuithof M, Otten R, Engels R, Kleinjan M. Smoking Behavior of Women Before, During, and after Pregnancy: Indicators of Smoking, Quitting, and Relapse. Eur Addict Res. 2019;25(3):132-144. doi: 10.1159/000498988. Epub 2019 Mar 27.
PubMed 30917383Caleyachetty R, Thomas GN, Toulis KA, Mohammed N, Gokhale KM, Balachandran K, Nirantharakumar K. Metabolically Healthy Obese and Incident Cardiovascular Disease Events Among 3.5 Million Men and Women. J Am Coll Cardiol. 2017 Sep 19;70(12):1429-1437. doi: 10.1016/j.jacc.2017.07.763.
PubMed 28911506Kahyaoğlu S, Özel Ş, Üstün YE, Erdöl C. Gebelik ve Sigara Bırakma. Jinekoloji-Obstetrik ve Neonatoloji Tıp Derg 2018, 15: 1.
Tarhan P, Yılmaz T. Gebelikte sigara kullanımı ve etkileyen faktörler. Sağlık Bilimleri ve Meslekleri Derg 2016, 3(3): 140-7.
Dilcen HY, Öztürk A, Yıldız MN. Gebelikte Sigara Kullanımının Algılanan Sosyal Destek, Benlik Saygısı ve Psikolojik Sağlamlık ile İlişkisi. Bağımlılık Derg 2021, 22(2): 161-70.
Chamberlain C, O'Mara-Eves A, Porter J, Coleman T, Perlen SM, Thomas J, McKenzie JE. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev. 2017 Feb 14;2(2):CD001055. doi: 10.1002/14651858.CD001055.pub5.
PubMed 28196405Harmer C, Memon A. Factors associated with smoking relapse in the postpartum period: an analysis of the child health surveillance system data in Southeast England. Nicotine Tob Res. 2013 May;15(5):904-9. doi: 10.1093/ntr/nts221. Epub 2012 Oct 8.
PubMed 23045522Jones M, Lewis S, Parrott S, Wormall S, Coleman T. Re-starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review. Addiction. 2016 Jun;111(6):981-90. doi: 10.1111/add.13309. Epub 2016 Mar 16.
PubMed 26990248Diamanti A, Papadakis S, Schoretsaniti S, Rovina N, Vivilaki V, Gratziou C, Katsaounou PA. Smoking cessation in pregnancy: An update for maternity care practitioners. Tob Induc Dis. 2019 Aug 2;17:57. doi: 10.18332/tid/109906. eCollection 2019.
PubMed 31582946Marufu TC, Ahankari A, Coleman T, Lewis S. Maternal smoking and the risk of still birth: systematic review and meta-analysis. BMC Public Health. 2015 Mar 13;15:239. doi: 10.1186/s12889-015-1552-5.
PubMed 25885887Notley C, Gentry S, Livingstone-Banks J, Bauld L, Perera R, Hartmann-Boyce J. Incentives for smoking cessation. Cochrane Database Syst Rev. 2019 Jul 17;7(7):CD004307. doi: 10.1002/14651858.CD004307.pub6.
PubMed 31313293Stead LF, Koilpillai P, Fanshawe TR, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Mar 24;3(3):CD008286. doi: 10.1002/14651858.CD008286.pub3.
PubMed 27009521
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smoking Cessation Intervention in Pregnancy According to the Web-Based Transtheoretic Model on Postpartum Smoking Relapse
- ClinicalTrials.gov ID
- NCT05711225
- Acronym / sponsor ID
- SYILMAZ
- Conditions
- Postpartum Smoking Relapse
- Keywords
- Transtheoretical Model, Web-based smoking cessation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Semra YILMAZUniversity, hospital or other
- Study start
- 24 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Feb 2023 (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 postpartum period is an important opportunity to improve maternal and fetal health by preventing smoking relapse in women. To achieve this goal, digital platforms, which are the latest technological developments are used. However, studies using digital platforms on smoking cessation and postpartum smoking relapse in pregnant women are limited in this area. The research was carried out to determine the effect of smoking cessation intervention prepared in line with the transtheoretic model on the digital platform, on preventing smoking relapse in the postpartum period. As a result of the research, it is thought that nurses will guide their professional practices with an evidence-based up-to-date approach.
Detailed description
Smoking during pregnancy is the most important cause of preventable complications. Smoking has many negative effects on fetal development and well-being as well as women's health. Pregnancy and childbirth can motivate women to quit smoking. However, it is stated that the rate of failure to quit smoking is higher in women than in men, and the period of resumption of smoking is shorter after an attempt to quit. In a large-scale study conducted in 54 low- and middle-income countries, it is stated that the prevalence of any tobacco use during pregnancy is 2.6%, with the highest prevalence being 15% in Turkey. The rates of smoking during pregnancy differ in studies conducted in our country. Due to the stigma and blame for smoking, many women report not smoking during pregnancy. This situation may prevent the exact number of pregnant women who smoke and prevent smoking cessation intervention and treatment. In our country, the rate of smoking during pregnancy was determined as 11.9% by Tarhan and Yılmaz, and as 13% by Dilcen et al. Smoking during pregnancy has numerous adverse effects on the mother and fetus. Intrauterine growth retardation, low birth weight, placenta previa and abruption, premature rupture of membranes, perinatal mortality during pregnancy; For newborns, the risk of developing asthma disease, infantile colic, obesity and sudden infant death are among the negative effects of maternal smoking. Factors affecting smoking during pregnancy were determined as planned pregnancy, number of pregnancies, gestational week, number of living children, frequency of receiving prenatal care, smoking status of the spouse and passive smoking.
It has been reported that women continue to smoke in the postpartum period despite quitting during pregnancy. In a meta-analysis study, it was shown that 43% of women who quit smoking during pregnancy started smoking again in the postpartum 6th month. It is stated that women continue to smoke after birth because they believe that they can no longer have a direct effect on their children. It has been reported that this situation may be related to smoking, postpartum fatigue, and stress related to child care. In addition, it has been shown that resumption of smoking after birth is associated with various factors such as young age, smoking status of people around, low income, and early cessation of breastfeeding. For this reason, it is stated that smoking in women is a complex phenomenon that can be affected by specific experiences related to social relations, pregnancy and birth, and this may cause an increase in postpartum relapse rates in women who quit smoking during pregnancy.
When interventions that support smoking cessation and prevention of relapse from pregnancy to postpartum are evaluated, it is stated that pregnancy is a trigger for smoking cessation and this period should be seen as an opportunity for smoking cessation interventions. Different intervention methods are used to quit smoking. Cessation interventions include informing, cognitive and behavioral treatments, hypnosis, acupuncture, and pharmacological treatments. There is insufficient evidence regarding the efficacy and safety of nicotine replacement, which is one of the pharmacological treatments used in smoking cessation during pregnancy. Instead, other interventions that are effective in quitting smoking during pregnancy; consultancy, feedback, financial incentives, telephone support programs, digital platforms and similar applications can be used. Digital interventions, including mobile health interventions, are considered an innovative way to provide evidence-based smoking cessation support to a hard-to-reach population. The use of digital platforms, including telephone, video, websites or mobile application technologies, can be used effectively to quit smoking during pregnancy. In their study, Derksen et al. found that social networks had a positive effect on the attitudes of pregnant women towards smoking cessation. Dascal et al., in their study to prevent postpartum smoking relapse, found that digital smoking cessation intervention had a positive effect on preventing postpartum smoking.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research was conducted as a pretest-posttest control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: smoking cessation intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the pregnant women in the experimental group. The pre-test data from the women in the experimental group were obtained through the website through the Participant Introduction Form,"Behavior Change Process Scale" (BCPS), "Self-Efficacy Scale/Encouraging Factors Scale" (SES/EFS) and "Decision Balance Scale" (DBS) before watching the videos. In addition, FNDT was applied to women who smoked during pregnancy. Post-test data from the women in the experimental group were collected by having them fill out the postpartum part of the Participant Identification Form at the 4th week postpartum after watching the animation videos, and FNDT, SCS, BCPS/EFS and DBS forms for those who still smoke, on the website. |
| Control group | No intervention | –The behavior stage was determined by applying the "Stages of Change Scale" (SCS) form to the women participating in the control group. The pre-test data of the women participating in the control group were applied via the Participant Identification Form, FNDT, SCS, BCPS/EFS and DBS and the FNDT form to those who continued to smoke during pregnancy. Post-test data from women in the control group were collected with the postpartum part of the Participant Identification Form at 4 weeks postpartum, FNDT, SCS, BCPS/EFS and DBS for smokers. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Don't have a smartphone
- Having the ability to use the Internet
- 32nd gestational week and below
- Reporting smoking at least two cigarettes per day in the 3 months before conception
Key exclusion criteria (1 listed)
- Not watching videos within the scope of web-based intervention.
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 intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse.Smoking cessation videos prepared according to the Web-Based Transtheoretic model A module was created on the web, with 5 sections, prepared by the researcher according to the Web-Based Transtheoretic model, for quitting smoking or for pregnant women who quit smoking to maintain this behavior. The modules are prepared in the form of animated videos in which the researcher is educational. Each module is arranged for an average of 5-10 minutes. Theoretical information about the content has been added under each video. | Behavioural | Experimental group |
Primary outcome
Measure 1- The Fagerström Test for Nicotine Dependence
Time frame: 15 months
The Fagerström Test for Nicotine Dependence was developed to determine the level of addiction to cigarettes.The scores that can be obtained from the scale range from 0 to 10. As addiction to cigarette increases, the score obtained from the scale increases. it was determined that the mean score of the scale decreased and the level of addiction decreased in the intervention group.
Measure 2- Behavior Change Process Scale
Time frame: 15 months
It reveals what processes the individual has experienced in the stages of behavior change.The lowest score that can be obtained from the scale is 22, and the highest is 110. The higher the score obtained from the scale, the higher the chance of success in changing behavior. The higher the score obtained from the scale, the higher the chance of success in changing behavior. It was determined that women in the intervention group had a higher chance of success in changing their smoking behavior.
Measure 3-Self-Efficacy Scale/Encouraging Factors Scale
Time frame: 15 months
The Self-Efficacy Scale/Encouraging Factors Scale shows the confidence that individuals have in order not to return to the harmful behavior they have changed when faced with difficult situations. The lowest score that can be obtained from the scale is 8 and the highest 40. A high score on the self-efficacy scale reveals the success of not smoking and quitting smoking despite encouraging factors. A high score on the Encouraging Factors Scale indicates that the probability of returning to the harmful behavior is high. The Encouraging Factors Scale is used with an answer format that is the opposite of the Self-Efficacy Scale. Despite the fact that the women in the intervention group faced stimulant situations, not returning to smoking behavior again shows that the power to resist is high.
Measure 4-Decision Balance Scale
Time frame: 15 months
The decision balance scale reveals the positive and negative perceptions of behavior change. The scale consists of two sub-dimensions that reveal the perception of the positive and negative aspects of smoking. The lowest score that can be obtained for the two sub-dimensions of the scale is 12, and the highest score is 60. A high score on the benefit (positive) sub-dimension indicates his indecision about changing behavior, while a high score on the harm (negative) sub-dimension indicates that has a higher chance of making and continuing a decision on behavior change. It was determined that women in the intervention group were more determined to change their smoking behavior and were more likely to maintain this determination.
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 2 Feb 2023.
- Background: PubMed 22145828Loukopoulou AN, Vardavas CI, Farmakides G, Rossolymos C, Chrelias C, Tzatzarakis MN, Tsatsakis A, Lymberi M, Connolly GN, Behrakis PK. Design and study protocol of the maternal smoking cessation during pregnancy study, (M-SCOPE). BMC Public Health. 2011 Dec 6;11:903. doi: 10.1186/1471-2458-11-903.
- Background: PubMed 23151329Lanting CI, van Wouwe JP, van den Burg I, Segaar D, van der Pal-de Bruin KM. [Smoking during pregnancy: trends between 2001 and 2010]. Ned Tijdschr Geneeskd. 2012;156(46):A5092. Dutch.
- Background: PubMed 29859815Lange S, Probst C, Rehm J, Popova S. National, regional, and global prevalence of smoking during pregnancy in the general population: a systematic review and meta-analysis. Lancet Glob Health. 2018 Jul;6(7):e769-e776. doi: 10.1016/S2214-109X(18)30223-7. Epub 2018 May 31.
- Background: PubMed 30917383Scheffers-van Schayck T, Tuithof M, Otten R, Engels R, Kleinjan M. Smoking Behavior of Women Before, During, and after Pregnancy: Indicators of Smoking, Quitting, and Relapse. Eur Addict Res. 2019;25(3):132-144. doi: 10.1159/000498988. Epub 2019 Mar 27.
- Background: PubMed 28911506Caleyachetty R, Thomas GN, Toulis KA, Mohammed N, Gokhale KM, Balachandran K, Nirantharakumar K. Metabolically Healthy Obese and Incident Cardiovascular Disease Events Among 3.5 Million Men and Women. J Am Coll Cardiol. 2017 Sep 19;70(12):1429-1437. doi: 10.1016/j.jacc.2017.07.763.
- BackgroundKahyaoğlu S, Özel Ş, Üstün YE, Erdöl C. Gebelik ve Sigara Bırakma. Jinekoloji-Obstetrik ve Neonatoloji Tıp Derg 2018, 15: 1.
- BackgroundTarhan P, Yılmaz T. Gebelikte sigara kullanımı ve etkileyen faktörler. Sağlık Bilimleri ve Meslekleri Derg 2016, 3(3): 140-7.
- BackgroundDilcen HY, Öztürk A, Yıldız MN. Gebelikte Sigara Kullanımının Algılanan Sosyal Destek, Benlik Saygısı ve Psikolojik Sağlamlık ile İlişkisi. Bağımlılık Derg 2021, 22(2): 161-70.
- Background: PubMed 28196405Chamberlain C, O'Mara-Eves A, Porter J, Coleman T, Perlen SM, Thomas J, McKenzie JE. Psychosocial interventions for supporting women to stop smoking in pregnancy. Cochrane Database Syst Rev. 2017 Feb 14;2(2):CD001055. doi: 10.1002/14651858.CD001055.pub5.
- Background: PubMed 23045522Harmer C, Memon A. Factors associated with smoking relapse in the postpartum period: an analysis of the child health surveillance system data in Southeast England. Nicotine Tob Res. 2013 May;15(5):904-9. doi: 10.1093/ntr/nts221. Epub 2012 Oct 8.
- Background: PubMed 26990248Jones M, Lewis S, Parrott S, Wormall S, Coleman T. Re-starting smoking in the postpartum period after receiving a smoking cessation intervention: a systematic review. Addiction. 2016 Jun;111(6):981-90. doi: 10.1111/add.13309. Epub 2016 Mar 16.
- Background: PubMed 31582946Diamanti A, Papadakis S, Schoretsaniti S, Rovina N, Vivilaki V, Gratziou C, Katsaounou PA. Smoking cessation in pregnancy: An update for maternity care practitioners. Tob Induc Dis. 2019 Aug 2;17:57. doi: 10.18332/tid/109906. eCollection 2019.
- 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.
SEMRA YILMAZ principal investigator
Research Assistant
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 intervention given according to the web-based transtheoretic model during pregnancy on postpartum smoking relapse. in people with Postpartum Smoking Relapse, run by Semra YILMAZ 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 1 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 2 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?
Measure 1- The Fagerström Test for Nicotine Dependence (time frame: 15 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?
On the ClinicalTrials.gov record for NCT05711225, which also lists 19 linked publications.
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 2 Feb 2023; AzTrials last refreshed its copy on 30 Oct 2026.