ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

anaethesia

sedation

memory recall

Condition category

Condition code

Anaesthesiology

Anaesthetics

Alternative and Complementary Medicine

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]

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]

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]

at the end of every 30 min

Primary outcome [2]

Recall of Introperative events judged by a 5 point self constructed questionaairre co-relating with significant intra operative events

Timepoint [2]

post operative follow up visit on same day evening of surgery (12 hours after end of surgery)

Secondary outcome [1]

pain,discomfort,disatisfaction during the surgery by VAS score

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

India

State/province [1]

Maharashtra

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Indian Council of Medical Research(ICMR)

Address [1]

Ansari Nagar, New Delhi - 110029

Country [1]

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]

Hospital

Name [1]

Mahatma Gandhi institute of medical sciences -Sevagram

Address [1]

Mahatma Gandhi institute of medical sciences -Sevagram,at post Sevagram(POST CODE :442102),district:-wardha,maharashtra,INDIA

Country [1]

India

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MGIMS-Sevagram Institutional Ethics committee

Ethics committee address [1]

Mahatma Gandhi Institute of Medical Sciennces-Sevagram,at post Sevagram(POST CODE:442102),district wardha,maharashtra,INDIA

Ethics committee country [1]

India

Date submitted for ethics approval [1]

Approval date [1]

07/08/2009

Ethics approval number [1]

MGIMS/IEC/MS/186/2009

Summary

Brief summary

THE EFFICACY OF MUSIC  IN LOWERING INTRA-OPERATIVE SEDATION REQUIREMENT AND RECALL OF INTRA OPERATIVE PROCESSES                                                                                                                                                                           
                                                                            
Background: It has been known for a long time that music has characteristic psychological and physiological effects in humans. It is a non-pharmacological technique that is inexpensive, non invasive and has no major side effects. Surgery with music is being increasingly reported at many of the today’s modern hospitals documenting Music’s powerful soothing, calming, sedating effects on subjects  including a significant reduction in the amount of anesthesia needed.                                                                                                                                                    
Aims and Objectives: 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  Methods:  60 Patients undergoing Elective Orthopedic,Gynaecological or Urological Surgeries under Regional anaesthesia between June to August 2009 were Randomized into either listening to Music(group M,n=30),or not listening to music(group C,n=30).Midazolum was given for sedation  in either of the groups to achieve a Observer’s Assessment Of sedation/alertness Score(OAS) of 3 or less.We noted the total dose of Midazolum required  and OAS scores  in both the groups.Post operative recall of Intraoperative processes by patient was assessed on answers to a  6 point Questionnaire and VAS score for pain ,discomfort and dissatisfaction with the sedative method employed was sought.  
                                                                                      Results:The Mean dose Of Midazolum to achieve Sedation was significantly lower (p<0.01) in the patients that listened to Music during their surgery.Desirable OAS score (<3) were significantly better in the Music group at 90 ant 120 min from start of the surgery .There was no Significant differences in the VAS scores for Pain ,Discomfort  or Dissatisfcation with the Sedative Method Employed in either groups(P>0.01).Intra operative Instances of Conversations between the doctors/nurses and other OR staff and Sounds Of Monitors,Instruments,etc were more significantly recalled by those who did not listened to music during their surgery(P<0.01). 
Conclusion: Our study concludes that 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  thus creating an effective,safe and cheap  non pharmacological method of sedating conscious patients operated under regional anaesthesia.We recommend that Music of their choice  via headsets  be provided to all the patients who are fond of  music listening during the Surgical procedures averaging  one and half hour duration or more .

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

dr vijay sharma

Address

department of anaesthesiology,MGIMS-Sevagram,at post Sevagram (POST CODE:442102), district:wardha,Maharashtra,INDIA

Country

India

Phone

+91 7152 260031

Fax

+91 7152 284333

drvijaysharma18@yahoo.co.in

Contact person for scientific queries

Name

dr vijay sharma

Address

department of anaesthesiology,MGIMS-Sevagram,at post Sevagram (POST CODE:442102), district:wardha,Maharashtra,INDIA

Country

India

Phone

+91 7152 260031

Fax

+91 7152 284333

drvijaysharma18@yahoo.co.in

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically