Alcohol Dependence SyndromeNCT04351217
Music vs Relaxation Training in Craving Reduction in Alcohol Dependence Syndrome
A study testing Music and Progressive Muscle Relaxation in people with Alcohol Dependence Syndrome, run by Kasturba Medical College at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alcohol Dependence Syndrome
- What is being tested?
- Music and Progressive Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 15 Sep 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome
- Abstinent for at least 1 week
Who cannot join
- Any other known psychiatric/physical condition
- Risk of Suicide or Relapse
- Less than 75% compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Dependence Syndrome
- Being tested
- Music, Progressive Muscle Relaxation
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.
Progressive Muscle RelaxationBehavioural
The instructions were recorded in both English and the local language, Kannada
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Music was Indian Classical Flute music, 23 minutes long. It was played on a speaker at equal volume to ensure uniformity. Receives: 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. Receives: Behavioral: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.
Measured: 5 days
Coping
The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping
Measured: 5 days
Secondary outcomes (1)
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start15 Sep 2019
- Primary completion30 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Dependence SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasturba Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shradha Chandrasekar, Kasturba Medical College
- Investigators
- Keshava Pai Pai, MD, Study chair, KMC Mangalore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351217
- Sponsor's protocol ID
- IEC KMC MLR 01-19/14
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 22 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to confidentiality agreement.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of Music and Relaxation Training on Craving Alcohol in Patients With Alcohol Dependence Syndrome: A Pilot Study
- ClinicalTrials.gov ID
- NCT04351217
- Acronym / sponsor ID
- IEC KMC MLR 01-19/14
- Conditions
- Alcohol Dependence Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kasturba Medical CollegeUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: MusicMusic was Indian Classical Flute music, 23 minutes long. It was played on a speaker at equal volume to ensure uniformity. |
| Progressive Muscle Relaxation | Experimental | Behavioral: Progressive Muscle RelaxationProgressive 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed with Mental and Behavioral Disorders due to Use of Alcohol, Dependence Syndrome
- Abstinent for at least 1 week
Key exclusion criteria (3 listed)
- Any other known psychiatric/physical condition
- Risk of Suicide or Relapse
- Less than 75% compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicRaga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics. | Behavioural | Music |
| Progressive Muscle RelaxationThe instructions were recorded in both English and the local language, Kannada | Behavioural | Progressive Muscle Relaxation |
Primary outcome
Craving
Time frame: 5 days
The level of craving for alcohol experienced by the patient, as measured through Alcohol Urge Questionnaire.
Coping
Time frame: 5 days
The patient's perceived ability to cope with their craving for alcohol, as assessed through a visual analogue scale for coping
1 secondary outcome
Single Question Exit Interview
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Individual participant dataSharing planned: No. IPD will not be shared due to confidentiality agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keshava Pai Pai, MD study chair
KMC Mangalore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music and Progressive Muscle Relaxation in people with Alcohol Dependence Syndrome, run by Kasturba Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Craving (time frame: 5 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.