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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153775
Other study ID # IRB031/55
Secondary ID
Status Completed
Phase N/A
First received May 26, 2014
Last updated May 31, 2014
Start date August 2012
Est. completion date November 2012

Study information

Verified date May 2014
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Cigarette craving usually occurs with unpleasant feelings, including stress. Progressive Muscle Relaxation (PMR) may reduce level of cigarette craving and/or withdrawal symptoms.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Thailand Department of Psychiatry, Faculty of Medicine, Chulalongkorn University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure Systolic and diastolic blood pressure, measured by an automated machine Immediately after a 20-minutes session of progressive muscle relaxation No
Other Pulse rate Pulse rate, measured by an automated machine Immediately after a 20-minutes session of progressive muscle relaxation No
Primary Craving 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 No
Secondary Cigarette withdrawal-related and non-withdrawal related feelings 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 No
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