Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00097

2 Trial Registration Date

2006-03-13

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

No

5 Primary Sponsor

No

6 Secondary Sponsor

No

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Man Kwun Lin

ii Address

About the study

iii Phone

pager:71163300 call 7410

iv Email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Man Kwun Lin

ii Address

About the study

iii Phone

pager:71163300 call 7410

iv Email

v Affiliation

vi Country

9 Official Scientific Title of the Study

A randomized controlled trial: a comparison of music intervention and non-music intervention on postoperative neurosurgical patients

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2006-01-20

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

No

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

music intervention

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

30 mins

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Rest

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

The eligible patient must meet the following inclusion criteria and must not meet the following exclusion criteria. Inclusion criteria: --undergoing any type of neurosurgery --receiving 1st neurosurgery since admission --Within 3 days of post-operation --Glasgow Coma Scale: 15 --At least 18 years of age and Chinese --Speaking Cantonese or Mandarin

ii Exclusion Criteria

Exclusion Criteria: --History of anxiety disorder --Bilateral Deafness --Glasgow Coma Scale < 15 --Systolic blood pressure < 80 mmHg --Diastolic blood pressure < 50 mmHg

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Historical control

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-09-09

21 Target Sample Size

90

22 Recruitment Status

Recruiting

23 Primary Outcome

The data will be evaluated at the end of March 2006

24 Secondary Outcome

The data will be evaluated at the Mid of May 2006

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-12-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2009-11-19