NCT04351217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 15, 2020

Last Update Submit

April 21, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Single Question Exit Interview

    5 days

Study Arms (2)

Music

EXPERIMENTAL

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

Behavioral: Music

Progressive Muscle Relaxation

EXPERIMENTAL

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

Interventions

MusicBEHAVIORAL

Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.

Music

The instructions were recorded in both English and the local language, Kannada

Progressive Muscle Relaxation

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KMC Mangalore

Mangalore, Karnataka, 575001, India

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Music TherapyAutogenic Training

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and ActivitiesHypnosisMind-Body Therapies

Study Officials

  • Keshava Pai Pai, MD

    KMC Mangalore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student, MSc Clinical Psychology

Study Record Dates

First Submitted

April 15, 2020

First Posted

April 17, 2020

Study Start

September 15, 2019

Primary Completion

January 30, 2020

Study Completion

April 1, 2020

Last Updated

April 22, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

IPD will not be shared due to confidentiality agreement.

Locations