- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02153775
Progressive Muscle Relaxation and Cigarette Craving
May 31, 2014 updated by: Rasmon Kalayasiri, Chulalongkorn University
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
Cigarette craving usually occurs with unpleasant feelings, including stress.
Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10330
- Department of Psychiatry, Faculty of Medicine, Chulalongkorn University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Progressive muscle relaxation
Progressive muscle relaxation: single 20-minutes session
|
Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.
|
|
No Intervention: Reading newspaper of the day
Reading newspaper of the day : single 20-minutes session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Immediately after a 20-minutes session of progressive muscle relaxation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Immediately after a 20-minutes session of progressive muscle relaxation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation
|
Systolic and diastolic blood pressure, measured by an automated machine
|
Immediately after a 20-minutes session of progressive muscle relaxation
|
|
Pulse rate
Time Frame: Immediately after a 20-minutes session of progressive muscle relaxation
|
Pulse rate, measured by an automated machine
|
Immediately after a 20-minutes session of progressive muscle relaxation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thatsanee Limsanon, M.Sc., Chulalongkorn University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
May 26, 2014
First Submitted That Met QC Criteria
May 31, 2014
First Posted (Estimate)
June 3, 2014
Study Record Updates
Last Update Posted (Estimate)
June 3, 2014
Last Update Submitted That Met QC Criteria
May 31, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB031/55
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.