| CTRI Number |
CTRI/2024/05/067976 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness to use a type of music for reducing anxiety in alcohol withdrawal patients |
|
Scientific Title of Study
|
Effectiveness to use binaural beats for reducing anxiety in alcohol withdrawal patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prithiviraj R |
| Designation |
Final year MBBS Student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8946051879 |
| Fax |
|
| Email |
prithiviraj16062003@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun S |
| Designation |
Hod, department of psychiatry |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam,
Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9787274770 |
| Fax |
|
| Email |
s.arun.gm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prithiviraj R |
| Designation |
Final year MBBS Student |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam,
Madagadipet,
Puducherry
PONDICHERRY
605107
India |
| Phone |
8946051879 |
| Fax |
|
| Email |
prithiviraj16062003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam,
Madagadipet,
Puducherry |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prithiviraj R |
Sri Manakula Vinayagar Medical College and Hospital |
Room no: 78 ,
Psychiatry OPD
Psychiatry department
Pondicherry
PONDICHERRY |
8946051879
prithiviraj16062003@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F102||Alcohol dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Binaural beats music |
95 Hz on right ear and 100 Hz on left ear (Which will be of pure frequency binaural beats without any background music), given through headphones ,
For a period of 10 minutes |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patient between 18 - 60 years of age who have been diagnosed as alcohol use disorder with alcohol withdrawal symptoms by psychiatrist |
|
| ExclusionCriteria |
| Details |
Patients with any hearing disorders, any other psychiatric disorder, or any other known medical illness causing anxiety |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Reduce the anxiety produced by alcohol withdrawal using binaural beats |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Published on journal
- For how long will this data be available start date provided 10-08-2024 and end date provided 31-08-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
This study aims to check the effectiveness of using a specific type of music called binaural beats to decrease the anxiety that occurs due to the stoppage of alcohol after being dependent to it. A binaural beats is a sound that is presented to two ears which is slightly different in each ear (different frequencies), the difference in sounds is perceived as a different sound to the brain which is said to cause a calming effect. Patient between 18 - 60 years of age who have been diagnosed as alcohol use disorder with alcohol withdrawal symptoms by psychiatrist are used in this study, Patients with any hearing disorders, any other psychiatric disorder, or any other known medical illness causing anxiety are excluded from the study. |