Effects of Deep Breathing,Self-Help Book in Cigarette Consumption,Anxiety,Depression and Motivation to Stop Smoking
NCT ID: NCT02693561
Last Updated: 2016-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
85 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a growing problem in all South American countries specially where poverty and the lack of instruction make people more vulnerable to the addiction. In addition, the smoking habit has been integrated to these countries cultures because of their economical dependence of it and ostensive marketing.
However, nowadays smoking harm effects are well known including the high risk of developing COPD (chronic obstructive pulmonary disease), heart diseases and many other forms of neoplasms.
The problems concerning smoking were first documented 40 years ago and are still one of the major causes of death which could be prevented. The medical costs associated with its treatment go far beyond the economical benefits from producing and commercializing tobacco.
It's estimated that in 2025, there will be 10 million people dying from tobacco consumption if the world panorama stays as it is. 90% of the teenagers who starts smoking become addicted by they are 19 years old.
According to the Smoking cessation guidelines - 2008 to stop smoking the addiction is recognized as a chronic condition and the interventions to change habits tends to be repeated as it's hard to get a efficient treatment. Even though, the stop smoking is associated in an increase of life quality and that's why it should be stimulated.
Three main mechanisms influence smoking, the first one is positive reinforcement, which is related to the release of acetylcholine, norepinephrine, serotonin, and GABA in the nervous central system caused by the action of nicotine that reduces appetite, improves mood and concentration and generate feelings of pleasure. The second is negative reinforcement, which generates the maintenance of cigarette use to prevent the symptoms of withdrawal symptoms like anxiety, increased appetite, dysphoria, irritability and difficulty in concentrating. The third is the respondent conditioning, which is stimulated by environmental factors, negative emotions and positive that lead to the act of smoke. Thus smoking is a complex behavior that is related to lifestyle, while trying to quit smoking many individuals experience symptoms of withdrawal syndrome which is a major cause of relapse. Deep breathing technique is cited by smokers as a strategy to alleviate these symptoms abstinence.
Mcclernon et al. They found results suggesting that guided deep breathing exercises relieve the symptoms of abstinence nicotine.
According to Tharion et al. deep breathing decreases respiratory rate and increase the variability of heart rate, stimulates the autonomic parasympathetic nervous system and increase the relaxing substances such as endorphins, so it is recommended as a relaxation technique, as well as decreasing tension, anger and depression.
Initially, in addition to clinical assessment of the smoker and assessing the degree of dependence, to assess the degree of motivation is fundamental to start therapy approach.
Prochaska and Diclemente described a stage of readiness model for change (motivation), with the steps of pre-contemplation, contemplation, preparation, action and maintenance (prevent the return behavior, undertaking measures to prevent relapse). First described as a linear model and later as a spiral model, since patients often have relapses, and remain long periods in maintenance stage.
Thus, motivational interventions are critical in smoker's approach in all clinical situations, even when participants need medical support. The self-help books can be effective and have important implications for public health. These psycho-educational interventions are complex and usually contains multiple components that interact and involve behavioral changes of people.
Self-help materials, according to Song et.al., can be effective and less costly than individual therapy or group sessions, which for many people is hard to get. Currently there are materials available in audio, video and computer programs, though the writings are the most commons.
A literature review by Boyce et al. And published by the Cochrane Library, concluded that materials that are tailored individually, eg for pregnant women or young, are more effective than non-adapted materials and both are effective for smoking cessation compared to individuals who did not use the self help material.
In this review, there was no additional benefit of evidence of the use of self-help material associated with other interventions such as advice from a health professional or replacement therapy nicotine and no selected study in the review used the deep breathing technique associated with reading self help material.
However, such evidence is tested in developed countries and more research is needed to investigate its effects in countries where support to smokers are not easily available.
Polonio I.B et al. , Published in 2013 a self-help book with smokers auxiliary order containing the principles of behavioral intervention conducted on Santa Casa de Sao Paulo smoking clinic.
Finally, the hypothesis of the study is that the book will be an effective tool to reduce anxiety, depression and increased motivation to quit smoking, the investigators believe that the addition of deep breathing to read the book will enhance these effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Deep Breathing Exercises
Technical Deep Breathing.
Deep Breathing Exercises
Technical Deep Breathing: Deep breathing is to deep breath and slowly through the nostrils until total lung capacity. At the end of inspiration is kept a few seconds of apnea and started after the expiration slowly. End-expiratory apnea will remain a few seconds to start new inspiration cycle. With this process the individual breathe about 6 times per minute. Breath learning occurs through visual feedback. In the intervention group will be held deep breathing for 10 minutes. Subjects will be instructed to deep breath for 10 minutes 2 times a day for 15 days beyond the period in which they cleft, which is one of the symptoms of withdrawal syndrome. Control and frequency of deep breathing will be obtained weekly through specific daily fill, which will be provided weekly.
Self-Help Book
Reading the self-help book.
Self-Help Book
Reading the self-help book.
Deep Breathing Exercises and Book
Technical Deep Breathing and Reading the self-help book.
Reading the self-help book and will be trained by the physical therapist to perform deep breathing.
Deep Breathing Exercises
Technical Deep Breathing: Deep breathing is to deep breath and slowly through the nostrils until total lung capacity. At the end of inspiration is kept a few seconds of apnea and started after the expiration slowly. End-expiratory apnea will remain a few seconds to start new inspiration cycle. With this process the individual breathe about 6 times per minute. Breath learning occurs through visual feedback. In the intervention group will be held deep breathing for 10 minutes. Subjects will be instructed to deep breath for 10 minutes 2 times a day for 15 days beyond the period in which they cleft, which is one of the symptoms of withdrawal syndrome. Control and frequency of deep breathing will be obtained weekly through specific daily fill, which will be provided weekly.
Control
Not suffer any intervention
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deep Breathing Exercises
Technical Deep Breathing: Deep breathing is to deep breath and slowly through the nostrils until total lung capacity. At the end of inspiration is kept a few seconds of apnea and started after the expiration slowly. End-expiratory apnea will remain a few seconds to start new inspiration cycle. With this process the individual breathe about 6 times per minute. Breath learning occurs through visual feedback. In the intervention group will be held deep breathing for 10 minutes. Subjects will be instructed to deep breath for 10 minutes 2 times a day for 15 days beyond the period in which they cleft, which is one of the symptoms of withdrawal syndrome. Control and frequency of deep breathing will be obtained weekly through specific daily fill, which will be provided weekly.
Self-Help Book
Reading the self-help book.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* minimum age of 18 years.
Exclusion Criteria
* use of beta blockers.
* pregnant women.
18 Years
30 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Anhembi Morumbi University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Iris Galdino Ueda
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Iris Ueda
Role: PRINCIPAL_INVESTIGATOR
Anhembi Morumbi University
Igor Polonio
Role: STUDY_DIRECTOR
Anhembi Morumbi University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anhembi Morumbi University
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Marcos Freire
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Muller F, Wehbe L. Smoking and smoking cessation in Latin America: a review of the current situation and available treatments. Int J Chron Obstruct Pulmon Dis. 2008;3(2):285-93. doi: 10.2147/copd.s2654.
McClernon FJ, Westman EC, Rose JE. The effects of controlled deep breathing on smoking withdrawal symptoms in dependent smokers. Addict Behav. 2004 Jun;29(4):765-72. doi: 10.1016/j.addbeh.2004.02.005.
Tharion E, Samuel P, Rajalakshmi R, Gnanasenthil G, Subramanian RK. Influence of deep breathing exercise on spontaneous respiratory rate and heart rate variability: a randomised controlled trial in healthy subjects. Indian J Physiol Pharmacol. 2012 Jan-Mar;56(1):80-7.
Busch V, Magerl W, Kern U, Haas J, Hajak G, Eichhammer P. The effect of deep and slow breathing on pain perception, autonomic activity, and mood processing--an experimental study. Pain Med. 2012 Feb;13(2):215-28. doi: 10.1111/j.1526-4637.2011.01243.x. Epub 2011 Sep 21.
Shields RW Jr. Heart rate variability with deep breathing as a clinical test of cardiovagal function. Cleve Clin J Med. 2009 Apr;76 Suppl 2:S37-40. doi: 10.3949/ccjm.76.s2.08.
Song F, Holland R, Barton GR, Bachmann M, Blyth A, Maskrey V, Aveyard P, Sutton S, Leonardi-Bee J, Brandon TH. Self-help materials for the prevention of smoking relapse: study protocol for a randomized controlled trial. Trials. 2012 May 30;13:69. doi: 10.1186/1745-6215-13-69.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AnhembiMU
Identifier Type: -
Identifier Source: org_study_id