Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome

Comparison Between the Use of Music and Relaxation Training on Craving Alcohol in Patients With Alcohol Dependence Syndrome: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence Syndrome
• Intervention / Treatment: Behavioral: Music; Behavioral: Progressive Muscle Relaxation

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Mangalore, Karnataka, India, 575001
      • KMC Mangalore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music; Music was Indian Classical Flute music, 23 minutes long. It was played on a speaker at equal volume to ensure uniformity.	Behavioral: Music; Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.
Experimental: Progressive Muscle Relaxation; 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.	Behavioral: Progressive Muscle Relaxation; The instructions were recorded in both English and the local language, Kannada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Craving	The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.	5 days
Coping	The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 days

Collaborators and Investigators

• Sponsor: Kasturba Medical College
• Investigators: Study Chair: Keshava Pai Pai, MD, KMC Mangalore

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Disease; Substance-Related Disorders; Alcoholism; Syndrome
• Other Study ID Numbers: IEC KMC MLR 01-19/14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared due to confidentiality agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No