Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000783426
Ethics application status
Approved
Date submitted
17/04/2016
Date registered
15/06/2016
Date last updated
15/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Play Activities Program for nursing home residents with chronic pain
Scientific title
A cluster randomized-controlled trial of a Play Activities Program
(PAP) for nursing homes residents with chronic pain.
Secondary ID [1] 289018 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic pain 298434 0
Condition category
Condition code
Alternative and Complementary Medicine 298532 298532 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the experimental group nursing homes will receive the 8-week
Play Activities Program (PAP). The PAP is a protocol-driven intervention which consists of one session per week for a total of 8 weeks. It is conducted in a group format with an emphasis on teamwork and learning various pain management techniques via game activities. Participants are encouraged to sit together in small groups of 5 to 6 for group activities in every session so as to create social bonding. The PAP will be carried out in the multi-function room, preferably with comfortable chairs, adequate lighting, and comfortable ventilation.

Each session lasts for 60 minutes. At the beginning of each session, participants will
complete 10 minutes of physical exercises including towel dancing; correct body posture and alignment; stretching of arms, legs, and body muscles performed together under the supervision and monitoring of the research team. Then follow by 40 minutes play activities and 10 minutes of portfolio entry.

Research assistant with nursing or health-care background will facilitate in the sessions. Examples of the play activities include:
Session One: Participants will will watch a series of photographs of the natural environment displayed by a projector for 10 minutes. They will be asked to choose the
photographs that they like the most.
Session Two: Each participant will be given a piece of paper and a few balls of cotton wool; the cotton wool balls will be placed on top of the participants’ sheet of paper. The participants need to blow the cotton wool onto the paper of the next person.
Session Three: The participants will be asked to hold a piece of cloth (6 feet x 3
feet in size) using both hands and to move a light ball from one side of the cloth
to the other side. There will be several holes in the cloth and the participants will have to work together to prevent the ball from falling into these holes.
Session Four: The participants will be given colourful paper, and they will make paper flowers and leaves.
Session Five: All participants will be seated in a big circle and together they will hold a 6-metre parachute. They will work together, using both hands to throw the parachute in the air and then release their hands, so that the parachute will stay up for 2-3
seconds before coming down;
Session Six: All participants will sit in a big circle. One person will be invited to stand in front of the group for 30 seconds. The person will then hide in a secret place and
modify his/her look. This person will return to the group and the participants will point out the changes that were made.
Session Seven: Each participant will be given a small handbag made of plain cloth
and will be invited to decorate their handbag with stickers.
Session Eight: The final session will be a summary of the previous sessions. The participants will play with the parachute (as in Session Four) and avoid pain traps (as in
Session Three). They will be encouraged to bring out their flowers and handbags as a reminder to shine like flowers and lead a pain-free life (as in Session Seven).

To ensure the adherence and compliance to protocol content and process, regular meetings will be held among the research team and nursing home staff; also, we shall carefully recruit, thoroughly train, provide ongoing and onsite supervision of research personnel. The consistency of research personnel training will be provided by the principal investigator. Register of attendance at each session will be done;
Intervention code [1] 294508 0
Treatment: Other
Comparator / control treatment
Participants in the control group nursing homes will gather together once a week for 8
weeks and listen to talks presented by the research team on diseases that are common among older adults and choices of healthful snacks and meals. Each seminar will last for 40-50 minutes.
Control group
Active

Outcomes
Primary outcome [1] 298027 0
current pain intensity and pain interferes as measured by Brief Pain Inventory
Timepoint [1] 298027 0
Baseline, at week 8 and at week 20
Secondary outcome [1] 322961 0
Pain self-efficacy as measured by Chinese version of the Pain Self-efficacy Questionnaire (PSEQ)
Timepoint [1] 322961 0
Baseline, at week 8 and at week 20
Secondary outcome [2] 322964 0
Happiness level as measured by Subjective Happiness Scale (SHS)
Timepoint [2] 322964 0
Baseline, at week 8 and at week 20
Secondary outcome [3] 322965 0
Health-related quality of life as measured by the 12-item Short-Form Health Survey (SF-12)
Timepoint [3] 322965 0
Baseline, at week 8 and at week 20
Secondary outcome [4] 322966 0
Acceptability of the PAP as measured by self-developed open-ended questionnaire
Timepoint [4] 322966 0
At the end of each PAP session
Secondary outcome [5] 322967 0
Objective assessment of pain as measured by saliva biomarkers including alpha-amylase, cortisol and beta-endorphin
Timepoint [5] 322967 0
Baseline, at week 8 and at week 20

Eligibility
Key inclusion criteria
- aged 65 or above
- able to speak and understand Cantonese
- willing and able to sign a consent form
- experienced pain in the last 3 months of intensity score >=3
- with Chinese Mini Mental State Examination (CMMSE) score >=20 and Hong Kong Montreal Cognitive Assessment (HK-MOCA) >=19
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- with a current or past history of a psychotic disorder
- lack of or inability to participate
- with moderate to severe dementia status
- with a history of acute stroke or acute myocardial infarction, severe chronic obstructive pulmonary disease, recent fractures, or surgery within the previous 2 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 7821 0
Hong Kong
State/province [1] 7821 0

Funding & Sponsors
Funding source category [1] 293389 0
Government body
Name [1] 293389 0
Research Grant Council
Country [1] 293389 0
Hong Kong
Primary sponsor type
Individual
Name
Dr. Mimi Mun Yee Tse
Address
FG 425, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country
Hong Kong
Secondary sponsor category [1] 292209 0
Individual
Name [1] 292209 0
Dr. Paul Hong Lee
Address [1] 292209 0
PQ 433, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country [1] 292209 0
Hong Kong
Secondary sponsor category [2] 292210 0
Individual
Name [2] 292210 0
Dr. Doris Yuet Lan Leung
Address [2] 292210 0
School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country [2] 292210 0
Hong Kong
Secondary sponsor category [3] 292211 0
Individual
Name [3] 292211 0
Dr. Richard Li
Address [3] 292211 0
Department of Medicine,
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road,
Chai Wan,
Hong Kong SAR
Country [3] 292211 0
Hong Kong
Secondary sponsor category [4] 292212 0
Individual
Name [4] 292212 0
Dr. Steven J. Linton
Address [4] 292212 0
School of Law, Psychology and Social Work,
Orebro University,
Fakultetsgatan 1,
702 81 Orebro,
Sweden
Country [4] 292212 0
Sweden
Secondary sponsor category [5] 292213 0
Individual
Name [5] 292213 0
Dr. Shamay Sheung Mei Ng
Address [5] 292213 0
ST 506, Physiotherapy section/Department of
Rehabilitation Sciences,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country [5] 292213 0
Hong Kong
Secondary sponsor category [6] 292214 0
Individual
Name [6] 292214 0
Dr. Winnie Wing Sze Wong
Address [6] 292214 0
PLAY INFINITY,
Room 1201, Sing Win Factory Building,
15-17 Shing Yip Street, Kwun Tong, Kowloon
Country [6] 292214 0
Hong Kong
Secondary sponsor category [7] 292215 0
Individual
Name [7] 292215 0
Dr. John Wai Man Yuen
Address [7] 292215 0
HJ 545, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country [7] 292215 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294846 0
Departmental Research Committee, The Hong Kong Polytechnic University
Ethics committee address [1] 294846 0
Ethics committee country [1] 294846 0
Hong Kong
Date submitted for ethics approval [1] 294846 0
Approval date [1] 294846 0
16/12/2014
Ethics approval number [1] 294846 0
HSEARS20141205003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52486 0
Dr Mimi Mun Yee Tse
Address 52486 0
FG 425, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country 52486 0
Hong Kong
Phone 52486 0
+852 2766 6541
Fax 52486 0
Email 52486 0
[email protected]
Contact person for public queries
Name 52487 0
Mimi Mun Yee Tse
Address 52487 0
FG 425, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country 52487 0
Hong Kong
Phone 52487 0
+852 2766 6541
Fax 52487 0
Email 52487 0
[email protected]
Contact person for scientific queries
Name 52488 0
Mimi Mun Yee Tse
Address 52488 0
FG 425, School of Nursing,
The Hong Kong Polytechnic University,
Hung Hom,
Kowloon,
Hong Kong SAR
Country 52488 0
Hong Kong
Phone 52488 0
+852 2766 6541
Fax 52488 0
Email 52488 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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