Clinical trial NCT05711225: Transtheoretic Model, Postpartum Smoking Relapse, Smoking Cessation Intervention
Official title: The Effect of Smoking Cessation Intervention in Pregnancy According to the Web-Based Transtheoretic Model on Postpartum Smoking Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Smoking Relapse
Keywords: Transtheoretical Model
Web-based smoking cessation intervention
Lead sponsor: Adiyaman University
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The research was conducted as a pretest-posttest control group experimental model.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria from the study:

• Not watching videos within the scope of web-based intervention.

Primary outcomes:
measure: Measure 1- The Fagerström Test for Nicotine Dependence
timeFrame: 15 months
measure: Measure 2- Behavior Change Process Scale
timeFrame: 15 months
measure: Measure 3-Self-Efficacy Scale/Encouraging Factors Scale
timeFrame: 15 months
measure: Measure 4-Decision Balance Scale
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Semra YILMAZ
state: Adiyaman
Study officials:
affiliation: Research Assistant
name: SEMRA YILMAZ
role: PRINCIPAL_INVESTIGATOR
References:
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