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Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome

Primary Purpose

Alcohol Dependence Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Music
Progressive Muscle Relaxation
Sponsored by
Kasturba Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Dependence Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome
  • Abstinent for at least 1 week

Exclusion Criteria:

  • Any other known psychiatric/physical condition
  • Risk of Suicide or Relapse
  • Less than 75% compliance

Sites / Locations

  • KMC Mangalore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Music

Progressive Muscle Relaxation

Arm Description

Music was Indian Classical Flute music, 23 minutes long. It was played on a speaker at equal volume to ensure uniformity.

Progressive Muscle Relaxation was recorded for uniformity of delivery, and was 22 minutes in length. It was played on a speaker at equal volume to ensure uniformity.

Outcomes

Primary Outcome Measures

Craving
The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.
Coping
The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping

Secondary Outcome Measures

Single Question Exit Interview
Each patient was a asked a single question during the final debriefing on the last day of the study. The question was "Please describe your experience with the music/exercise". Their answers were recorded verbatim and were translated from Kannada as needed

Full Information

First Posted
April 15, 2020
Last Updated
April 21, 2020
Sponsor
Kasturba Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT04351217
Brief Title
Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome
Official Title
Comparison Between the Use of Music and Relaxation Training on Craving Alcohol in Patients With Alcohol Dependence Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasturba Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of the study was to compare the effectiveness of Music and Progressive Muscle Relaxation as interventions to reduce craving, increase coping, and understand the subjective experience of the interventions with patients diagnosed with Mental and Behavioral Disorders due to Alcohol, Dependence Syndrome, over a 5 day period.
Detailed Description
Craving for alcohol produces an aversive, uncomfortable state, with autonomic arousal similar to that in anxiety disorders, and is the main factor leading to relapse. Music has been shown to reduce anxiety and stress levels. Progressive Muscle Relaxation (PMR) is the intervention of choice for treatment of anxiety and related syndromes. This study aimed to compare efficacy of PMR and music in reducing levels of alcohol craving and increasing perceived ability to cope with the craving. The intervention was conducted over 5 days with two randomised group of 10 patients each. The patients were assigned to either group based on randomizer sequencing. Initial motivation was assessed before beginning the study. Measures of craving level and coping were collected on Day 1, 3 and 5. Single question exit interview was conducted to understand subjective perception of the patients regarding the techniques. Significant difference was found in coping levels through use of PMR (p = 0.01), and subjective reduction in craving levels was reported by patients in the music group, though this was not statistically significant. Thus, PMR may be used as an adjunct to increase coping abilities in patients with alcohol dependence, while music may be a useful tool to reduce craving but cannot be conclusively commented upon without further research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence Syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two interventions, Music and Progressive Muscle Relaxation (PMR) were used. Music was Indian Classical Flute music, 23 minutes long. PMR was recorded for uniformity of delivery, and was 22 minutes in length.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music
Arm Type
Experimental
Arm Description
Music was Indian Classical Flute music, 23 minutes long. It was played on a speaker at equal volume to ensure uniformity.
Arm Title
Progressive Muscle Relaxation
Arm Type
Experimental
Arm Description
Progressive Muscle Relaxation was recorded for uniformity of delivery, and was 22 minutes in length. It was played on a speaker at equal volume to ensure uniformity.
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Muscle Relaxation
Intervention Description
The instructions were recorded in both English and the local language, Kannada
Primary Outcome Measure Information:
Title
Craving
Description
The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.
Time Frame
5 days
Title
Coping
Description
The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Single Question Exit Interview
Description
Each patient was a asked a single question during the final debriefing on the last day of the study. The question was "Please describe your experience with the music/exercise". Their answers were recorded verbatim and were translated from Kannada as needed
Time Frame
5 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome Abstinent for at least 1 week Exclusion Criteria: Any other known psychiatric/physical condition Risk of Suicide or Relapse Less than 75% compliance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keshava Pai Pai, MD
Organizational Affiliation
KMC Mangalore
Official's Role
Study Chair
Facility Information:
Facility Name
KMC Mangalore
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared due to confidentiality agreement.

Learn more about this trial

Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome

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