Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00006

2 Trial Registration Date

2005-09-05

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Reserach fund for the control of infectious diseases/ Health and health services research fund

5 Primary Sponsor

Proferssor Wong Yeung Shan Samuel

6 Secondary Sponsor

Function

Please specify

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

i Name

Karen Lee Ka Man

ii Address

iii Phone

tel: 2252 8769

iv Email

v Affiliation

research assistant

vi Country

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

i Name

Prof Samuel Wong

ii Address

iii Phone

iv Email

email: yeungshanwong@cuhk.edu.hk

v Affiliation

Assistant Professor

vi Country

9 Official Scientific Title of the Study

A randomized, controlled clinical trial: The effect of mindfulness-based stress reduction programme on pain as well as quality of life in chronic pain sufferers

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?

2005-06-30

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

chronic pain

15 Intervention

i Types of intervention

Other

Please specify

cognitive

ii Description/ name of Intervention/article

mindfulness-based stress reduction program

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

2 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

educational lectures on chronic pain

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

inclusion: aged 18-60, chronic pain last for three months or more

ii Exclusion Criteria

exclusion: 1) concuurent treatment with other modalities other than medicaions for pain or psychological symptoms 2) concurrent DSM-IV Axis diagnosis 3) past participation in an MRSR group 4) ucrrent or prior practice of meditation or relaxation technique including MBSR

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2006-02-23

21 Target Sample Size

100

22 Recruitment Status

Unknown

23 Primary Outcome

pain intensity

24 Secondary Outcome

mood status and symptoms quality of life

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-04-01

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000621

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

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Trial History Detail on 2012-08-31