Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000576628
Ethics application status
Approved
Date submitted
20/05/2014
Date registered
29/05/2014
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Gardening activities for nursing home residents
Scientific title
The use of horticultural therapy to enhance psychological well-being and relieve chronic pain in nursing home residents: A pilot study
Secondary ID [1] 284621 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pain 291932 0
Depressive symptoms 291933 0
Condition category
Condition code
Alternative and Complementary Medicine 292286 292286 0 0
Other alternative and complementary medicine
Mental Health 292326 292326 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12-week horticultural therapy will be given to the participants. There will be one session per week with each session last around 30-40 minutes.
The horticultural therapy will include an introduction of the gardening activities and various types of plants and seedlings; making natural pesticides, applying natural pesticides to the plants, watering and positioning plants. Pots, seeds and all other gardening equipment will be provided to each participant and each of them will be responsible for growing their own plant.
A planting diary will be developed and given to the participants for recording the planting schedules and photographs of their own plants.
A group of 4-5 older adults will gather together in each session and the sessions will be led by the research assistant.
Intervention code [1] 289406 0
Treatment: Other
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292152 0
Pain intensity as measured by numeric rating scale (NRS) and Brief Pain Inventory (BPI-T)
Timepoint [1] 292152 0
Baseline, at week 3 and at week 6 before the horticultural therapy (HT) session, at week 12 upon the completion of the HT
Primary outcome [2] 292153 0
Depressive symptoms as measured by Geriatric Depression Scale (GDS-15)
Timepoint [2] 292153 0
Baseline, and at week 12 upon the completion of the HT
Secondary outcome [1] 308310 0
Loneliness level as measured by the Loneliness Scale
Timepoint [1] 308310 0
Baseline, and at week 12 upon the completion of the HT
Secondary outcome [2] 308311 0
Happiness level as measured by Subjective Happiness Scale
Timepoint [2] 308311 0
Baseline, and at week 12 upon the completion of the HT

Eligibility
Key inclusion criteria
- aged 65 years or older
- able to communicate in Cantonese
- Mini-Mental State Examination score of 6 or above
- pain in the past 3 months
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- bed-bound
- history of mental disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/11/2014
Actual
4/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6059 0
Hong Kong
State/province [1] 6059 0

Funding & Sponsors
Funding source category [1] 289249 0
Government body
Name [1] 289249 0
Intend to submit to the Health and Medical Research Fund (HMRF)
Country [1] 289249 0
Hong Kong
Primary sponsor type
Individual
Name
Dr. Mimi Tse
Address
FG425,
Polytechnic University,
Hung Hom,
Kowloon
Country
Hong Kong
Secondary sponsor category [1] 287930 0
Individual
Name [1] 287930 0
Dr. Paul Lee
Address [1] 287930 0
PQ433,
Polytechnic University,
Hung Hom,
Kowloon
Country [1] 287930 0
Hong Kong
Secondary sponsor category [2] 287931 0
Individual
Name [2] 287931 0
Professor Thanos Karatzias
Address [2] 287931 0
Edinburgh Napier University
FHLSS - Sighthill Campus
Room 4.B.29
Sighthill Court
Edinburgh EH11 4BN
Country [2] 287931 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291028 0
Departmental Research Committee
Ethics committee address [1] 291028 0
Polytechnic University,
Hung Hom,
Kowloon
Ethics committee country [1] 291028 0
Hong Kong
Date submitted for ethics approval [1] 291028 0
03/06/2013
Approval date [1] 291028 0
26/07/2013
Ethics approval number [1] 291028 0

Summary
Brief summary
Chronic pain is common in our aging population. It negatively impacts on both physical and psychological well-being. This study aims to
a) examine the prevalence of depression and chronic pain among nursing home residents;
b) examine whether depressive symptoms are positively associated with pain intensity;
c) examine whether horticultural therapy reduces pain and depressive symptoms and enhance the psychological well-being of nursing homes residents

It is hypothesized that
a) depression and pain will be positively associated;
b) those with current depressive symptoms will experience more chronic pain than those without depressive symptoms;
c) horticultural therapy will significantly reduce depressive symptoms and pain;
d) the reduction in depression will be positively associated with the reduction in pain.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 636 636 0 0
/AnzctrAttachments/366362-Ethical approval_1077_RO[1].pdf

Contacts
Principal investigator
Name 48506 0
Dr Mimi Tse
Address 48506 0
FG425,
Polytechnic University,
Hung Hom,
Kowloon
Country 48506 0
Hong Kong
Phone 48506 0
+852 27666541
Fax 48506 0
Email 48506 0
[email protected]
Contact person for public queries
Name 48507 0
Dr Mimi Tse
Address 48507 0
FG425,
Polytechnic University,
Hung Hom,
Kowloon
Country 48507 0
Hong Kong
Phone 48507 0
+852 27666541
Fax 48507 0
Email 48507 0
[email protected]
Contact person for scientific queries
Name 48508 0
Dr Mimi Tse
Address 48508 0
FG425,
Polytechnic University,
Hung Hom,
Kowloon
Country 48508 0
Hong Kong
Phone 48508 0
+852 27666541
Fax 48508 0
Email 48508 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.