Category
»
Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
»
2019
INTERVENTION: Behavioural Device Experimental dedign Participants will initially go through an initial evaluation that will include general data, comorbidities and history of smoking. The Wisconsin scale, developed to assess the intensity of nicotine withdrawal symptoms, will also be applied. Participants will then be included in a specialized smoking cessation program that utilizes an intensive approach to quitting smoking for a period of 12 weeks. At the beginning of the program participants will be randomized (randomized via Excel) into two intervention groups: Application Group (GApp), which will participate in all stages of the cessation program in person and additionally, also use a mobile application developed specifically for this project that has extra features and tools as complementary measures for cessation. The second group (Control Group ‐ GC) will be formed by individuals who will participate only in the cessation program (all stages), however without the use of the cellular application. After the end of the program, the rate of smoking cessation, the intensity of withdrawal symptoms and the level of satisfaction of their experience in both groups will be analyzed. For GApp, a qualitative analysis will be performed through a focus group analyzing their experience with the mobile application. Initial evaluation An initial evaluation will be carried out at the beginning of the study by means of an interview of the therapists with the participants, which will include the participant's sociodemographic data such as: name, age, date of birth, sex, address, race, use medication, consumption of alcoholic beverages and cigarettes daily. Concomitant pathologies such as anxiety, depression, bipolar disorder, acute myocardial infarction, epilepsy, stroke, hypertension, diabetes, and other diseases will also be reported. At the end of the evaluation will be questioned the degree of motivation for smoking cessation. Wisconsin Smoking Withdrawal Scale It was developed by a gr Tobacco Use Cessation CONDITION: F00‐F99 Smoking ; Tobacco Use Disorder Tobacco Use Disorder PRIMARY OUTCOME: It is expected as a primary outcome that the Application Group has a smoking cessation rate greater than the control group that will not use the tool. SECONDARY OUTCOME: A s a secondary outcome We expect a higher satisfaction level (measured by questionnaire) in the Application group. INCLUSION CRITERIA: Smoking patients; in the age group between 25 and 70 years.
Epistemonikos ID: 4d68c03fb8ab402b91fa86c14ae3866f2df3f2f1
First added on: Aug 25, 2024