Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00461

2 Trial Registration Date

2015-07-02

i Registration Status

Prospective

3 Secondary IDs

2015.016-T

4 Source(s) of Funding

Nethersole School of Nursing, CUHK

5 Primary Sponsor

KO Shuk Yee

6 Secondary Sponsor

NA

Function

Please specify

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

i Name

KO Shuk Yee

ii Address

Shatin, NT, Hong Kong

iii Phone

93286472

iv Email

ksy024@ha.org.hk

v Affiliation

Student of Nethersole School of Nursing, CUHK

vi Country

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

i Name

KO Shuk Yee

ii Address

Shatin, NT, Hong Kong

iii Phone

93286472

iv Email

ksy024@ha.org.hk

v Affiliation

Student of Nethersole School of Nursing, CUHK

vi Country

9 Official Scientific Title of the Study

The effects of music interventions on anxiety and pain for Chinese adult patients undergoing colonoscopy

10 Public Title

The effects of music interventions on anxiety and pain for Chinese adult patients undergoing colonoscopy

i Public Title in Chinese 研究名稱

音樂對結腸內視鏡檢查者焦慮及痛楚的成效

11 Short Title (Optional)

The effects of music interventions for Chinese adult patients undergoing colonoscopy

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-03-27

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Anxiety, pain, sedative and analgesic medication requirements, heart rate, blood pressure, and procedure satisfaction

15 Intervention

i Types of intervention

Other

Please specify

Music

ii Description/ name of Intervention/article

patients listen to “easy listening music” from different authors such as Tsui Siu Fung, Sam Hui, Alan Tam, and Lam Chi Cheung and so on through earphones connected to a MP3 player

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

Music is played 20 minutes before and during colonoscopy procedure

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Participants are received the usual care plus music interventions. The usual care consists of before the colonoscopy, patients are required to receive a bowel cleaning preparation in order to ensure that the bowel is clear for proper visualization. The day of the procedure, patient is admitted to the day surgical ward, history and vital signs are completed, the consent of colonoscopy is obtained, and an intravenous line is inserted into the patient.

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

1)Conscious, oriented
2)Adult patient(18 years of age or above) with scheduled ambulatory colonoscopy
3)Able to communicate in Chinese, and read and write Chinese language
4)Haemodynamic stability as evidenced by blood pressure between 90 to 140mmHg systolic and 60 to 90mmHg diastolic before colonoscopy.

ii Exclusion Criteria

1) Have visual and hearing impairment due to inability to understand the study and questionnaire
2) History of senile dementia, cognitive disorders and psychiatric disorders as indicated in medical record

iii Age Minimum

Adult patient (18 years of age or above)

iv Age Maximum

below 80 years of age

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

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

2015-07-17

21 Target Sample Size

80

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Anxiety is measured before and after procedure
Pain is measured after procedure

24 Secondary Outcome

Sedative and analgesic medication requirements are recorded during procedure
Heart rate and blood pressure are measured on admission, during and 30 minutes after procedure
Procedure satisfaction is measured after procedure

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-07-02

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

NA

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Trial History Detail on 2015-07-02