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Progressive Muscle Relaxation and Cigarette Craving

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ClinicalTrials.gov Identifier: NCT02153775
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Rasmon Kalayasiri, Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE August 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
Craving [ Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation ]
Craving, a strong desire for using a substance when abstaining from substance, was measured by the Penn Alcohol Rating Scale - adapted (PACS-adapted) and the Visual Analog Scale (VAS).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2014)
Cigarette withdrawal-related and non-withdrawal related feelings [ Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation ]
Cigarette withdrawal symptoms (i.e., anxious, hungry, feeling bad, restless) and non-withdrawal (i.e., high, stimulated, paranoid, tongue - tied) (59-61), as measured by using the Visual Analog Scale (VAS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 31, 2014)
  • Blood pressure [ Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation ]
    Systolic and diastolic blood pressure, measured by an automated machine
  • Pulse rate [ Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation ]
    Pulse rate, measured by an automated machine
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Progressive Muscle Relaxation and Cigarette Craving
Official Title  ICMJE Preliminary Study of Effects of Progressive Muscle Relaxation on Cigarette Craving and Withdrawal Symptoms of Experienced Smokers in Acute Cigarette Abstinence : A Randomised Control Trial
Brief Summary Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.
Detailed Description The study reports on a study investigating the acute effects of a one-time application of progressive muscle relaxation on craving for cigarettes in smokers who were instructed to abstain from cigarettes for 3 hours.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Addiction
Intervention  ICMJE Behavioral: Progressive Muscle Relaxation
Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.
Study Arms  ICMJE
  • Experimental: Progressive muscle relaxation
    Progressive muscle relaxation: single 20-minutes session
    Intervention: Behavioral: Progressive Muscle Relaxation
  • No Intervention: Reading newspaper of the day
    Reading newspaper of the day : single 20-minutes session
Publications * Limsanon T, Kalayasiri R. Preliminary effects of progressive muscle relaxation on cigarette craving and withdrawal symptoms in experienced smokers in acute cigarette abstinence: a randomized controlled trial. Behav Ther. 2015 Mar;46(2):166-76. doi: 10.1016/j.beth.2014.10.002. Epub 2014 Nov 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 31, 2014)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or more
  • Daily cigarette smokers

Exclusion Criteria:

  • Hospitalization
  • Participating in cigarette dependency treatment or trying to quit smoking with other methods
  • Uncontrolled blood pressure
  • Current other substance users (except alcohol)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153775
Other Study ID Numbers  ICMJE IRB031/55
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rasmon Kalayasiri, Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thatsanee Limsanon, M.Sc. Chulalongkorn University
PRS Account Chulalongkorn University
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP