Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00584

2 Trial Registration Date

2018-02-12

i Registration Status

Prospective

3 Secondary IDs

2017.309-T

4 Source(s) of Funding

Nil

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Not Applicable

Please specify

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

i Name

Cho Lee Wong

ii Address

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

iii Phone

3943 8166

iv Email

jojowong@cuhk.edu.hk

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

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

i Name

Yeung Man Ting

ii Address

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

iii Phone

60395118

iv Email

kittyeung1218@hotmail.com

v Affiliation

The Nethersole School of Nursing, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Effects of immersive virtual reality as distraction intervention in reducing pain and anxiety among paediatric cancer patients undergoing peripheral intravenous catheters insertion: a pilot trial

10 Public Title

Effects of immersive virtual reality as a distraction intervention in reducing pain and anxiety among paediatric cancer patients undergoing peripheral intravenous catheters insertion: a pilot trial

i Public Title in Chinese 研究名稱

沉浸式虛擬實境干預措施對兒童接受靜脈導管程序的有效性研究

11 Short Title (Optional)

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?

2017-09-12

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.309-T

14 Medical Condition Being Studied

cancer

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Immersive virtual reality

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16 Comparative Treatments

i Description/ name of comparative treatments

Standard care

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

aged between 7 and 18

scheduled to undergo PIC

could understand Chinese

ii Exclusion Criteria

identified cognitive and learning problems in their medical record

brain tumors or metastasis

contact precaution

history of seizures and motion sickness,

iii Age Minimum

7

iv Age Maximum

18

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

A randomized controlled trial with repeated assessments

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

0

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-02-16

21 Target Sample Size

60

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

pain level

ii The metric or method of measurement used

VAS score

iii The timepoint(s) of primary interest

Before and after the intervention

24 Secondary Outcome

i The Name of the outcome

anxiety level

ii The metric or method of measurement used

The State Anxiety Scale for Children

iii The timepoint(s) of primary interest

Before and after the intervention

Secondary Outcome

i The Name of the outcome

heart rate

ii The metric or method of measurement used

iii The timepoint(s) of primary interest

Before, during, and after the intervention

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-03-11

27 Primary Registry and Trial Identifying Number

ChiCTR1800014893

28 Date of Registration in Primary Registry

2018-02-12

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Trial History Detail on 2018-03-22