Clinical trial NCT04351217: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence Syndrome
Lead sponsor: Kasturba Medical College
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Craving
timeFrame: 5 days
measure: Coping
timeFrame: 5 days
Secondary outcomes:
measure: Single Question Exit Interview
timeFrame: 5 days
Other outcomes:
Locations:
city: Mangalore
country: India
facility: KMC Mangalore
state: Karnataka
Study officials:
affiliation: KMC Mangalore
name: Keshava Pai Pai, MD
role: STUDY_CHAIR
References: