Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00465

2 Trial Registration Date

2015-07-23

iRegistration Status

Prospective

3 Secondary IDs

2015.005-T

4 Source(s) of Funding

Research Project of Playright by Kuenflower Management Inc. (in honour of Kwong Sik Kwan and Kwong Hui May Kuen) to the UBS Optimus Foundation

5 Primary Sponsor

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

6 Secondary Sponsor

Playright Children's Play Association

Function

Form a group with the primary sponsor in which the responsibilities of sponsorship are allocated among the members of the group

Please specify

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

i Name

Chan Wai Man Connie

ii Address

Rm 808, The Nethersole School of Nursing, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T.

iii Phone

3943-9303

iv Email

b138617@cuhk.edu.hk

v Affiliation

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

vi Country

HKSAR

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

i Name

Professor Ip Wan Yim

ii Address

Rm 826, The Nethersole School of Nursing, 8/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T.

iii Phone

3943-6229

iv Email

ip2013@cuhk.edu.hk

v Affiliation

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

vi Country

HKSAR

9 Official Scientific Title of the Study

The stress-reducing effects of therapeutic play on children undergoing cast-removal procedure.

10 Public Title

The stress-reducing effects of therapeutic play on children undergoing cast-removal procedure.

i Public Title in Chinese 研究名稱

治療性遊戲對兒童接受石膏拆除程序的有效性研究

11 Short Title (Optional)

N/A

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2015-03-16

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2015.005-T

14 Medical Condition Being Studied

Cast-removal in children

15Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Therapeutic play by hospital play specialists

iii Dosage form of the intervention

behavioural

iv Dosage of the intervention

once only

v Duration of the intervention

about 20 minutes

vi Frequency of the intervention

one time only

16Comparative Treatments

i Description/ name of comparative treatments

usual care in the orthopaedic out-patient clinic for cast-removal procedure

ii Dosage form of the comparative treatments

usual care

iii Dosage of the comparative treatments

once only

iv Duration of the comparative treatments

about 30 mins

v Frequency of the comparative treatments

one time only

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Children who are 3-12 years of age and their parents are able to speak and understand Cantonese and read Chinese will be invited to join the study.

ii Exclusion Criteria

Children who have had a cast removed within 3 months and have neurological or developmental problems as shown on the medical record will be excluded from the study.

iii Age Minimum

3

iv Age Maximum

12

v Gender

Both Male and Female

18 Study Type

Interventional

19Study Design

i Randomization

Randomized

Please specify

two-arm randomized controlled trial

ii Nature of control

Active

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

Trial subjects

iv Group Assignment

Parallel

v Study Phase

1

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-08-12

21 Target Sample Size

300

22 Recruitment Status

Recruiting

23 Primary Outcome

Anxiety and emotional distress levels of children during the cast-removal procedure

24 Secondary Outcome

Satisfaction levels of parents and cast technicians in respect of the cast-removal procedure (measure at the end of the procedure)

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2017-01-23

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006822

28 Date of Registration in Primary Registry

2015-07-27

Back History

Trial Detail