Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000532505
Ethics application status
Not yet submitted
Date submitted
8/05/2015
Date registered
27/05/2015
Date last updated
27/05/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain Management in the Aged Care Population: The Impact of Light Therapy.
Scientific title
Will the implementation of Light Therapy (either bright or natural light) decrease pain levels in an aged care population, as opposed to no intervention/care as usual.
Secondary ID [1] 286662 0
Nil
Universal Trial Number (UTN)
U1111-1169-9826
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain in an older population 294996 0
Condition category
Condition code
Physical Medicine / Rehabilitation 295261 295261 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The two interventions being tested are Bright Light Therapy (arm 1) and Natural Light Therapy (arm 2). All participants will wear Actiwatches throughout the study, to monitor sleep and wake cycles, activity, and light exposure. All participants will be required to complete a Sleep Diary each day, detailing their sleep the previous day and night. Pain levels will be measured utilising the Brief Pain Inventory.
Arm 1: Group 1 will be placed in a control group for the first 2 weeks, receiving care as usual. After this, Group 1 will be administered Bright Light Therapy using bright light therapy glasses. The researcher will attend PresCare aged care facility every morning for 10 days (2 weeks, Monday to Friday), to administer the glasses to participants. Participants will wear these glasses for 30 minutes each morning, between the hours of 6:30am and 7:30am. The glasses emit blue-green 500 nm dominant wavelength, UV-free light, and participants will be exposed to 30 minutes at 506 lux. The glasses have an adjustable nose piece, one size fits all. The glasses green light source has been independently tested for ocular safety to the standard CEI IEC 62471. The green light has been shown to be more effective in impacting older populations circadian rhythms due to clouding of the eye, which influenced the choice of glasses to be utilized or this study. After the 2 weeks, Group 1 will receive care as usual again, acting as a control group, still completing Sleep Diaries and wearing the Actiwatches.
Arm 2: Group 2 will be a control group for the first 2 weeks, receiving care as usual but wearing the Actiwatches and completing the Sleep Diary. After 2 weeks, Natural Light Therapy will be administered to the group of participants. This will entail participants being exposed to natural sunlight for a block of 30 mins per day, to determine the impact of natural light on pain, and allow a comparison between Bright Light and Natural Light Therapy. Participants will be taken outside in the morning for 30 mins, and will be exposed to natural light for this time. After this, Group 2 will receive care as usual for another 2 weeks.
Intervention code [1] 291810 0
Treatment: Devices
Intervention code [2] 291880 0
Treatment: Other
Comparator / control treatment
Both groups will receive care as usual for the first 2 weeks of the study, followed by Group 1 receiving bright light therapy for 2 weeks, and Group 2 receiving natural light therapy intervention for 2 weeks. Both groups will then receive care as usual as a control group again for another 2 weeks.
Each group will be administered the Brief Pain Inventory at baseline, after the first 2 weeks, after 4 weeks, and then at 6 weeks, at each differing intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 295010 0
Pain scores as measured using the Brief Pain Inventory.
This measures pain severity and pain interference.
Timepoint [1] 295010 0
This measure will be administered to both groups at baseline, at 2 weeks (completion of care as usual/control 1), 4 weeks (the cessation of light therapy interventions), and 6 weeks (completion of care as usual/control 2).
Secondary outcome [1] 314575 0
While sleep quality/quantity is not a primary outcome, the correlation between sleep and pain is well-documented, and sleep quality will be discussed as a secondary composite outcome. Sleep diaries will be kept by all participants, to monitor quality and quantity of sleep for 6 weeks, the duration of the study. This will also record napping throughout the day, and degree of restfulness after sleep.
Timepoint [1] 314575 0
Daily throughout the intervention, from Day 1 to Day 42.
Secondary outcome [2] 314577 0
Incidental light exposure will be a secondary outcome that will be monitored for. This is to identify any differences between individuals, and account for light exposure outside of the light therapy. Actiwatches will be worn by all participants to monitor sleep, activity and light exposure throughout the study. These will be worn by both groups, to monitor incidental light exposure and control for additional light exposure. Actiwatches are lightweight, waterproof and non-obstructive, and have been scientifically proven to monitor the sleep-wake cycle, activity and light exposure.
Timepoint [2] 314577 0
Actiwatches to be worn throughout the experiment, from Day 1 - Day 42.
Secondary outcome [3] 314726 0
Activity levels of participants will be a secondary outcome that will be monitored for. This is to identify any changes in activity levels as the intervention progresses, and account for any differences in pain outcomes. Actiwatches will be worn by all participants to monitor sleep, activity and light exposure throughout the study. These will be worn by both groups, to monitor activity levels throughout. Actiwatches are lightweight, waterproof and non-obstructive, and have been scientifically proven to monitor the sleep-wake cycle, activity and light exposure.
Timepoint [3] 314726 0
Daily through the intervention, from Day 1 to 42.

Eligibility
Key inclusion criteria
Participants must be aged 65 and up, reporting pain, and scoring an average of 4 or above on the Brief Pain Inventory pain severity scale. Participants must be cognitively able to complete the Brief Pain Inventory and a sleep diary, either verbally or written.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For both intervention arms, GP or clinical nurse approval will be sought before commencing the interventions. People who are taking photosensitizing medications are to be excluded, unless written approval from a doctor or clinical nurse can be obtained. The Bright Light Therapy glasses do not produce the wavelengths that photosensitizing medications react to, but it has been recommended that using any light therapy should be avoided, as well as avoiding direct sunlight until you are no longer using photosensitizing medication.

For intervention Arm 1, exclusion criteria includes people with epilepsy, people who suffer from manic depressive psychosis or bipolar. People with cataracts, glaucoma or retinal disorders will need written permission from a doctor or clinical nurse in order to participate.

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)
This study will be quasi-randomized. Due to stringent inclusion and exclusion conditions, participants who are ineligible to participate in the Bright Light Therapy intervention arm will be allocated to the Natural Light Therapy intervention arm if eligible. Bright Light Therapy intervention arm participants will consist of people who meet all the inclusion criteria, and have doctor or clinical nurse approval.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This intervention will utilise a small-n single case AB design.
By looking at each participant as a single case, due to the presumed small sample size, descriptives and graphs will be produced to demonstrate data and any significant effect sizes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 291242 0
Other
Name [1] 291242 0
Individual - Stephanie Zylstra
Country [1] 291242 0
Australia
Funding source category [2] 291243 0
Other
Name [2] 291243 0
Individual - Lynne Parkinson
Country [2] 291243 0
Australia
Primary sponsor type
Individual
Name
Stephanie Zylstra
Address
Central Queensland University
Bruce Highway
Rockhampton QLD 4701
Country
Australia
Secondary sponsor category [1] 289917 0
University
Name [1] 289917 0
Lynne Parkinson
Address [1] 289917 0
Central Queensland University
Bruce Highway
Rockhampton QLD 4701
Country [1] 289917 0
Australia
Secondary sponsor category [2] 289918 0
Other
Name [2] 289918 0
Sandra Thomson, Facility Manager
Address [2] 289918 0
PresCare Alexandra Gardens
20 Withers St North Rockhampton QLD 4701
Country [2] 289918 0
Australia
Other collaborator category [1] 278464 0
University
Name [1] 278464 0
Lynne Parkinson
Address [1] 278464 0
CQUniversity, Bruce Highway
Rockhampton QLD 4701
Country [1] 278464 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292799 0
Central Queensland University Human Research Ethics Committee
Ethics committee address [1] 292799 0
Ethics committee country [1] 292799 0
Australia
Date submitted for ethics approval [1] 292799 0
12/05/2015
Approval date [1] 292799 0
Ethics approval number [1] 292799 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 451 451 0 0
/AnzctrAttachments/368508-Brief Pain Inventory.pdf
Attachments [2] 452 452 0 0
/AnzctrAttachments/368508-Participant Consent Form.docx
Attachments [3] 453 453 0 0
/AnzctrAttachments/368508-Participant Demographic Questions.docx
Attachments [4] 454 454 0 0
/AnzctrAttachments/368508-PresCare approval.pdf
Attachments [5] 455 455 0 0
/AnzctrAttachments/368508-Sleep Diary.pdf
Attachments [6] 456 456 0 0
/AnzctrAttachments/368508-Actiwatch2 Brochure.pdf

Contacts
Principal investigator
Name 57090 0
Prof Lynne Parkinson
Address 57090 0
B32, CQuniversity
Bruce Highway, Rockhampton
QLD 4701
Country 57090 0
Australia
Phone 57090 0
+61409698382
Fax 57090 0
Email 57090 0
[email protected]
Contact person for public queries
Name 57091 0
Stephanie Zylstra
Address 57091 0
Central Queensland University
Bruce Highway
Rockhampton QLD 4701
Country 57091 0
Australia
Phone 57091 0
+61409698382
Fax 57091 0
Email 57091 0
[email protected]
Contact person for scientific queries
Name 57092 0
Stephanie Zylstra
Address 57092 0
Central Queensland University
Bruce Highway
Rockhampton QLD 4701
Country 57092 0
Australia
Phone 57092 0
+61409698382
Fax 57092 0
Email 57092 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.