Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00498

2 Trial Registration Date

2016-01-07

i Registration Status

Prospective

3 Secondary IDs

Protocol Version 2 dated 16 November 2015

4 Source(s) of Funding

The Hong Kong Pain Society

5 Primary Sponsor

Hospital Authority

6 Secondary Sponsor

The Chinese University of Hong Kong

Function

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

Please specify

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

i Name

LAM Chi Shan

ii Address

Pain Management Center
1/F, BLock A
Alice Ho Liu Ling Nethersole Hospital
11 Chuen On Road
Tai Po, New Territories
HONG KONG

iii Phone

(852)26893155

iv Email

lcs178@ha.org.hk

v Affiliation

Alice Ho Miu Ling Nethersole Hospital, Hospital Authority

vi Country

HONG KONG, CHINA

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

i Name

CHI SHAN LAM

ii Address

Pain Management Center
1/F, BLock A
Alice Ho Liu Ling Nethersole Hospital
11 Chuen On Road
Tai Po, New Territories
HONG KONG

iii Phone

(852)97453211

iv Email

lcs178@ha.org.hk

v Affiliation

Department of Anaesthesiology and Operating Services, Hospital Authority

vi Country

Hong Kong

9 Official Scientific Title of the Study

A quantitative and qualitative evaluation of labyrinth waking on chronic pain patients: a pilot study

10 Public Title

A quantitative and qualitative evaluation of labyrinth waking on chronic pain patients: a pilot study

i Public Title in Chinese 研究名稱

慢性疼痛病人體驗明陣的量性和質性評估：一项前瞻性研究

11 Short Title (Optional)

Labyrinth Walking Study

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?

2015-12-23

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

CREC 2015.639

14 Medical Condition Being Studied

Chronic Pain

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Labyrinths are found across the globe and have been used over thousands of years. They do not belong to any religion, denomination, or culture (Densford, 2007).

A labyrinth is a single path that leads to a center. It is unique in that it does not copy anything from nature, but mostly likely was conjured up in the human imagination (McCullough, 2004, cited in Cunningham, 2012, pp. 4—5).
The process of walking the labyrinth involves three phases: walking toward the center, the stage of releasing or letting go of thoughts or cares; reaching the center, the stage of receiving new insight or spiritual grace; and walking back out, the stage of union or of returning to the world with new awareness. The labyrinth can be walked individually or as group (single-file), and is often done slowly, in silence or to soft music (Monroe, 2008).
They are currently being used worldwide in a variety of ways: to seek spiritual guidance, to quiet the mind, to cope with problems or loss, to reduce stress or develop more balance, to ease transition, to increase creativity or simply to be self-reflective (Monroe, 2008).

The experience of walking a labyrinth is entirely individual, unpredictable and even a little mysterious (Monroe, 2008). Their therapeutic use has been exploded in the United States in the past 15years (Artress, 2006, cited in Densford 2007). Physical, psychological, and spiritual benefits are shown. Physically, a labyrinth walk can lower the blood pressure and slow the breathing. Psychologically, labyrinths help people process grief, make decisions, and resolve conflicts. Spiritually, many people find that walking a labyrinth is a fitting metaphor for the inner journey and that it expands their connection to something greater than themselves (Wasko-Flood, 2010).

Reference

Cunningham, M., 2012. Integrating spirituality in clinical social work practice: walking the labyrinth. Boston: Pearson.

Densford, L., 2007. The path to healing. An Alabama provider adds a labyrinth to its campus. Behavioral Healthcare 27:9, pp. 28-29.

Monroe, M., 2008. Labyrinth: walking the path of the heart: could this centuries-old meditation help you or your clients explore the body-mind connection? (Inner idea) IDEA Fitness Journal, 5:3, pp.81—83.

Wasko-Flood, S., 2010. CHAPTER 8: Labyrinths for Creativity and Peace in Schools, Action in Teacher Education, 32:5-6, pp. 144-159, DOI: 10.1080/01626620.2011.10519479

iii Dosage form of the intervention

Labyrinth Walking

iv Dosage of the intervention

1 to 2 hours

v Duration of the intervention

1 to 2 hours

vi Frequency of the intervention

Weekly for six weeks

16 Comparative Treatments

i Description/ name of comparative treatments

No control

ii Dosage form of the comparative treatments

No control

iii Dosage of the comparative treatments

No control

iv Duration of the comparative treatments

No control

v Frequency of the comparative treatments

No control

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

A convenient sample from the Pain Management Centre at the Alice Ho Miu Ling Nethersole Hospital (AHNH)

ii Exclusion Criteria

Lack of consent

Untreated psychiatric conditions

Suicidal risk

Illiterate (either written or spoken Cantonese)

Cannot complete the self-report worksheet sample

iii Age Minimum

18

iv Age Maximum

Nil

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Factorial

v Study Phase

1

Please specify

vi Study Objectives (Optional)

The aim of the study is to evaluate whether labyrinth walking is a suitable tool for incorporating into the biopsychospiritual approach in chronic pain management

20 Anticipated trial start date

2016-05-17

21 Target Sample Size

14

22 Recruitment Status

Recruiting

23 Primary Outcome

i The Name of the outcome

Pain intensity

ii The metric or method of measurement used

Numerical Rating Scale

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Affect

ii The metric or method of measurement used

Hospital Anxiety and Depression Scale

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Cognitions

ii The metric or method of measurement used

Pain Catastrophizing Scale

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Power and endurance

ii The metric or method of measurement used

Standing and sitting tolerances

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Power and endurance

ii The metric or method of measurement used

6 minutes walk

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Spirituality

ii The metric or method of measurement used

Adult Hope Scale

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Primary Outcome

i The Name of the outcome

Spirituality

ii The metric or method of measurement used

WHO-5 Well Being Scale

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

24 Secondary Outcome

i The Name of the outcome

Safety

ii The metric or method of measurement used

Report of adverse effect or concern

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Secondary Outcome

i The Name of the outcome

Change

ii The metric or method of measurement used

Biological, psychological, spiritual

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Secondary Outcome

i The Name of the outcome

Self-Understanding

ii The metric or method of measurement used

Identity

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

Secondary Outcome

i The Name of the outcome

Pain understanding

ii The metric or method of measurement used

Meaning & Purpose

iii The timepoint(s) of primary interest

Before, during and after six sessions of labyrinth walking

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-25

27 Primary Registry and Trial Identifying Number

ChiCTR-OOC-16007767

28 Date of Registration in Primary Registry

2016-01-07

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Trial History Detail on 2016-04-24