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Trial registered on ANZCTR
Registration number
ACTRN12614000195651
Ethics application status
Approved
Date submitted
15/02/2014
Date registered
24/02/2014
Date last updated
24/02/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Peer volunteers in a pain management program for older adults
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Scientific title
Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a single group trial
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Secondary ID [1]
284051
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Nil
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Universal Trial Number (UTN)
U1111-1153-1767
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
pain among frail older adults
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loneliness level among frail older adults
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happiness level among frail older adults
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Condition category
Condition code
Alternative and Complementary Medicine
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0
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Other alternative and complementary medicine
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Public Health
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be given an 8-week group-based integrated pain management program supplemented with peer volunteers. There will be 16 sessions, with two 1-hour sessions each week.
Session 1 of each week includes:
1) 30 minutes of interactive teaching and sharing - Contents include introduction of pain, impact of pain, drug and non-drug therapy, five sensation therapy (touch, smell, taste, hearing & vision), making a photo album, paper fan, paper flowers and vase, dried flower bags and festival decorations;
2) 20 minutes of exercise - Specific exercises for shoulder and neck, back, arms, whole body and balancing and towel dancing will be taught;
3) 10 minutes of entry and reviewing “I can do it” booklet. The research assistant will lead the sessions and peer volunteers will assist.
Session 2 of each week will only be led by peer volunteers . It includes 30 minutes of revision, 20 minutes of exercise and 10 minutes of entry and reviewing “I can do it” booklet.
Peer volunteers will be provided two training (2 hours each) before the commencement of the voluntary service. They will be informed on the procedure of the program, correct implementation of a variety of exercises and multisensory therapy, communication skills and personal safety. Demonstration of exercise and multisensory therapy will be shown to them. They will also pair up with nursing students and role playing, and to lead a presentation and demonstration in the second workshop.
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Intervention code [1]
288744
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Treatment: Other
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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pain as measured by the numeric rating scale
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Assessment method [1]
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Timepoint [1]
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baseline, beginning of each session from week 1-8, 8 and 12 weeks after intervention commencement
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Secondary outcome [1]
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functional mobility as measured by Timed Up and Go Test
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Assessment method [1]
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Timepoint [1]
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baseline, 8 and 12 weeks after intervention commencement
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Secondary outcome [2]
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physical activity as measured by the Global Physical Activity Questionnaire
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Assessment method [2]
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Timepoint [2]
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baseline, 8 and 12 weeks after intervention commmencement
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Secondary outcome [3]
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use of non-pharmacological methods counted as number of times per week
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Assessment method [3]
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Timepoint [3]
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baseline, 8 and 12 weeks after intervention commencement
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Secondary outcome [4]
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Loneliness level as measured by Loneliness Scale
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Assessment method [4]
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Timepoint [4]
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baseline, 8 and 12 weeks after intervention commencement
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Secondary outcome [5]
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Happiness level as assessed by the Chinese version of the subjective happiness scale
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Assessment method [5]
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Timepoint [5]
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baseline, 8 and 12 weeks after intervention commencement
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Secondary outcome [6]
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Volunteer questionnaire - to assess vollunteers' self-efficacy to learn and implement the IPMP, self-rated pain management knowledge; rating of the training, satisfaction with the program and skills in delivering it, attitudes and prior experiences engaging in voluntary programs for older adults, expectation to the program; perceptions of barriers and facilitators to the program
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Assessment method [6]
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Timepoint [6]
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before volunteer training, after volunteer training, 4 and 12 weeks after intervention commencement
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Eligibility
Key inclusion criteria
Inclusion criteria for participants:
- aged 60 or above
- scored at least 6 in the Abbreviated Mental Test
- experience pain more than 3 months
- scored at least 1 in the frailty index
- able to hear and understand Cantonese
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- patient with cognitive impairment
- patient with history of mental disorders
- patient with cancer and currently on cancer treatment
- patient suffers from conditions that limit safe participation
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/03/2014
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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Hong Kong
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State/province [1]
5812
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Internal funds, School of Nursing, The Hong Kong Polytechnic University
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Address [1]
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The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country [1]
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Hong Kong
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Primary sponsor type
Individual
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Name
Dr. Mimi Mun Yee Tse
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Address
FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country
Hong Kong
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr. Paul Hong Lee
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Address [1]
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PQ433, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country [1]
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Hong Kong
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Secondary sponsor category [2]
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Individual
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Name [2]
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Dr. Shamay Sheung Mei Ng
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Address [2]
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ST506, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country [2]
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Hong Kong
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Secondary sponsor category [3]
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Individual
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Name [3]
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Mrs. Bik Kwan Tsien-Wong
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Address [3]
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EF710, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country [3]
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Hong Kong
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Departmental Research Committee, The Hong Kong Polytechnic University
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Ethics committee address [1]
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The Hong Kong Polytechnic University, Hung Hom
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Ethics committee country [1]
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Hong Kong
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Date submitted for ethics approval [1]
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Approval date [1]
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18/02/2014
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Ethics approval number [1]
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HSEARS20140124002
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Summary
Brief summary
Studies found that educational interventions were effective among older adults only in the short-term and those who participated in these intervention programs often fall back into their old habits upon completion of the program. As literature suggested that interventions including some type of social support have great potential to increase participation and adherence, it raises the question of whether the effects of an integrated pain management program can be extended with the use of peer volunteers. The aim of this study is to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity, functional mobility, physical activity, loneliness level, happiness level and use of non-pharmacological pain-relieving methods among frail older adults with chronic pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Mun Yee Tse
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Address
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FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country
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Hong Kong
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Phone
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+852 2766 6541
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Mun Yee Tse
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Address
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FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country
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Hong Kong
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Phone
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+852 2766 6541
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Mun Yee Tse
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Address
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FG425, The Hong Kong Polytechnic University, Hung Hom, Kowloon
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Country
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Hong Kong
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Phone
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+852 2766 6541
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Fax
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Email
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Peer volunteers in an integrative pain management program for frail older adults with chronic pain: Study protocol for a randomized controlled trial.
2014
https://dx.doi.org/10.1186/1745-6215-15-205
N.B. These documents automatically identified may not have been verified by the study sponsor.
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