Effects of Deep Breathing,Self-Help Book in Cigarette Consumption,Anxiety,Depression and Motivation to Stop Smoking

NCT02693561 | Unknown DMC

• 1 other identifier: AnhembiMU
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Smoking is an important public health issue. The self help books may have important motivational implications which associated with deep breath exercises could cease the habit. Goals: Verify the effectiveness of the deep breaths exercises from the self help books along with the two motivational interventions to quit smoking on the anxiety, depression and daily consumption levels. Method: The study will be both prospective and controlled. Individuals will be distributed randomly in 4 different groups: The first group will be doing the deep breath exercises, the second group will read a self help book, the third group will do both reading and exercises and the fourth group will be the control. Anxiety, depression, motivational level and the cigarettes daily consumption will be evaluated previously and after the 15 days intervention. Expected results: Decreasing in anxiety, depression and cigarette consumption plus an increase in the motivation to quit smoking.

Conditions

Smoking Cessation

Keywords

Self-help book; Deep breathing

Outcome Measures

Primary Outcomes (1)

• Motivation measured with the Portuguese version of the "URICA" (Scale University of Rhode Island Change Assessment)

  Scale developed by Prochaska and DiClemente, translated and validated to Portuguese used to measure the motivation to change. Determines different motivational stages in solving a problem. To classify the individual in the pre-contemplation stage (stage where the person does not consider the need for help), contemplation stage (the individual is aware of the problem), preparation stage (construction of attempts to change their behavioraction stage (taking concrete attempts to modify their behavior) and maintenance stage (the lifestyle is modified). The answers are given on a scale of 1 (completely disagree with the statement) to 5 (strongly agree). Each statement is linked to a different motivational stage and at the end of test, the investigators can determine which is the patient motivational level considering which stage his score was higher.

  2 weeks

Secondary Outcomes (3)

• Nicotine addiction measured whit the Portuguese version of the Fagerstrom test

  2 weeks

• Depression measured with the portuguese version of the "BDI" ( The Beck Depression Inventory).

  2 weeks

• Anxiety measured with the Portuguese version of the "BAI" ( The Beck Anxiety Inventory)

  2 weeks

Study Arms (4)

Deep Breathing Exercises

ACTIVE COMPARATOR

Technical Deep Breathing.

Behavioral: Deep Breathing Exercises

Self-Help Book

ACTIVE COMPARATOR

Reading the self-help book.

Behavioral: Self-Help Book

Deep Breathing Exercises and Book

ACTIVE COMPARATOR

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.

Behavioral: Deep Breathing Exercises

Control

NO INTERVENTION

Not suffer any intervention

Interventions

Deep Breathing Exercises BEHAVIORAL

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.

Deep Breathing Exercises; Deep Breathing Exercises and Book

Self-Help Book BEHAVIORAL

Reading the self-help book.

Self-Help Book

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• students from the Anhembi Morumbi University.
• minimum age of 18 years.

You may not qualify if:

• serious chronic diseases
• use of beta blockers.
• pregnant women.

Sponsors & Collaborators

• Anhembi Morumbi University: lead

Study Sites (1)

Anhembi Morumbi University

São Paulo, São Paulo, 03164-000, Brazil

RECRUITING

Related Publications (6)

• 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.

  PMID: 18686737 RESULT

• 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.

  PMID: 15135559 RESULT

• 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.

  PMID: 23029969 RESULT

• 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.

  PMID: 21939499 RESULT

• 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.

  PMID: 19376980 RESULT

• 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.

  PMID: 22647290 RESULT

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Iris Ueda

  Anhembi Morumbi University

  PRINCIPAL INVESTIGATOR

• Igor Polonio

  Anhembi Morumbi University

  STUDY DIRECTOR

Central Study Contacts

Iris Ueda

CONTACT

irisgaldino@terra.com.br

Iris Galdino

CONTACT

irisgaldino@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 26, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: August 1, 2016
• Last Updated: February 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)