Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001048976
Ethics application status
Approved
Date submitted
24/09/2011
Date registered
6/10/2011
Date last updated
10/10/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Efficacy of Music in lowering intra-operative sedation requirement and recall of intra-operative processes.
Scientific title
To find out whether patients undergoing elective surgery under regional anesthesia, who hear a pre-selected music during surgery through a head-phone, need a lower dose of intra-operative sedatives and have a reduced recall of intra-operative processes ?
Secondary ID [1] 263103 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaethesia 270854 0
sedation 270855 0
memory recall 270856 0
Condition category
Condition code
Anaesthesiology 271031 271031 0 0
Anaesthetics
Alternative and Complementary Medicine 271032 271032 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
'Music therapy' intraoperatively was given via head phones in the intervention group for surgeries lasting atleast 1 hour or more duration.
In the group in which Music therapy was given, patients opted music of their choice from 3 categories “spiritual”, “filmy” or“instrumental” all of which were in patient’s preferred language . patients were asked for their favourite category of music from above three broad category and their preferrence accordingly noted in their pre-anaesthetic record sheet.A portable music player(philips-Mp3 player) attached with larger ear head phones was placed in the intervention group and audio volume controll switch was placed in patients hands so that they could adjust volume of Music according to their wish.Music player was however covered in non transparent covering for blinding purposes.
This intervention was administered in addition to standard treatment i.e use of sedative drug named midazolum whenever felt necessary.
Intervention code [1] 269448 0
Treatment: Other
Comparator / control treatment
active control "standard treatment' with use of drug Midazolum. usual doses are 1 to 2 mgs administered intravenously ,then 1 mg top ups as needed ,monitored against level of sedation desired.
Control group
Active

Outcomes
Primary outcome [1] 279689 0
Total dose of midazolum needed for patients receiving intraoperative music to achieve and maintain a constant level of sedation(OAS score > 3), judged by observer assessment of Sedation/Alertness scale(OAS).
Timepoint [1] 279689 0
at the end of every 30 min
Primary outcome [2] 279690 0
Recall of Introperative events judged by a 5 point self constructed questionaairre co-relating with significant intra operative events
Timepoint [2] 279690 0
post operative follow up visit on same day evening of surgery (12 hours after end of surgery)
Secondary outcome [1] 294226 0
pain,discomfort,disatisfaction during the surgery by VAS score
Timepoint [1] 294226 0
post operative follow up visit on same day evening of surgery (12 hours after end of surgery)

Eligibility
Key inclusion criteria
1.Patients for elective surgeries planned under regional anaesthesia,
2.ASA status I or II
3.Age group from18 to 60 years
4.Patients either liking music or ambivalent
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Age<18 or >60 years
2.ASA status III and above
3.Patients with hearing impairment
4.Known psychiatric or memory disorder
5.Unwillingness to participate in the study(no Consent)
6.Disliking for Music

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by self handpicking the similar looking opaque envelopes containing group randomisation chits.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3864 0
India
State/province [1] 3864 0
Maharashtra

Funding & Sponsors
Funding source category [1] 269929 0
Government body
Name [1] 269929 0
Indian Council of Medical Research(ICMR)
Country [1] 269929 0
India
Primary sponsor type
Government body
Name
Indian Council of Medical Research(ICMR)
Address
Ansari Nagar, New Delhi - 110029
Country
India
Secondary sponsor category [1] 268930 0
Hospital
Name [1] 268930 0
Mahatma Gandhi institute of medical sciences -Sevagram
Address [1] 268930 0
Mahatma Gandhi institute of medical sciences -Sevagram,at post Sevagram(POST CODE :442102),district:-wardha,maharashtra,INDIA
Country [1] 268930 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271896 0
MGIMS-Sevagram Institutional Ethics committee
Ethics committee address [1] 271896 0
Ethics committee country [1] 271896 0
India
Date submitted for ethics approval [1] 271896 0
Approval date [1] 271896 0
07/08/2009
Ethics approval number [1] 271896 0
MGIMS/IEC/MS/186/2009

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33197 0
Address 33197 0
Country 33197 0
Phone 33197 0
Fax 33197 0
Email 33197 0
Contact person for public queries
Name 16444 0
dr vijay sharma
Address 16444 0
department of anaesthesiology,MGIMS-Sevagram,at post Sevagram (POST CODE:442102), district:wardha,Maharashtra,INDIA
Country 16444 0
India
Phone 16444 0
+91 7152 260031
Fax 16444 0
+91 7152 284333
Email 16444 0
[email protected]
Contact person for scientific queries
Name 7372 0
dr vijay sharma
Address 7372 0
department of anaesthesiology,MGIMS-Sevagram,at post Sevagram (POST CODE:442102), district:wardha,Maharashtra,INDIA
Country 7372 0
India
Phone 7372 0
+91 7152 260031
Fax 7372 0
+91 7152 284333
Email 7372 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.