Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000150943p
Ethics application status
Submitted, not yet approved
Date submitted
5/02/2020
Date registered
13/02/2020
Date last updated
13/02/2020
Date data sharing statement initially provided
13/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of viewing images on skin healing
Scientific title
The effect of viewing images on skin healing in healthy participants
Secondary ID [1] 300454 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing 316123 0
Condition category
Condition code
Skin 314411 314411 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to one of two groups; artwork and control. Participants will be asked to view a series of images at two time-points throughout the study; during a tape stripping procedure which removes the top-layer of skin through the repeated application of tape and during a 30 minute healing period, while the tape-stripping wound heals. This procedure is a non-invasive and minimally painful method to assess wound healing in humans. Before the 30 minute healing period begins, participants will be told that at the end of the study they will be completing a laboratory stress task, in order to increase their stress levels. However, they will not actually be completing the stress task.

Participants in the artwork condition will view a series of natural New Zealand landscape paintings during these two periods, while participants in the control condition will view digitally scrambled versions of these paintings. These scrambled versions, have the same colour of the original paintings, however, the pixels of the pictures have been mixed up so there is no longer an idea of the content of the image. There will be 20 of each image, and the images will be on screen for 1 minutes each. Participants will not be asked to continuously view the images, and can look away if they want. The amount of time they are looking at the images vs looking away will be quantified to control for in the analysis of the data.

The intervention will only be delivered to the participants in a one-off, two hour session. This procedure will occur in a research clinic at the University of Auckland and will be conducted by a University doctoral candidate.
Intervention code [1] 316753 0
Treatment: Other
Comparator / control treatment
The control condition will view digitally scrambled versions of the landscape paintings during the two viewing periods.
Control group
Active

Outcomes
Primary outcome [1] 322758 0
Change in trans-epidermal water loss (TEWL) as measured using the Tewameter TM 300
Timepoint [1] 322758 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [1] 379586 0
Mood as measured using a Modified version of the actual affect sub scale of the Affect Valuation Index
Timepoint [1] 379586 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [2] 379587 0
Changes in current stress levels as measured using 100mm visual analogue scales
Timepoint [2] 379587 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [3] 379588 0
Changes in current anxiety levels as measured using 100mm visual analogue scales
Timepoint [3] 379588 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [4] 379589 0
Changes in current relaxation levels as measured using 100mm visual analogue scales
Timepoint [4] 379589 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [5] 379590 0
Changes in heart rate as measured using a wearable fitness tracker
Timepoint [5] 379590 0
Continuous measurement throughout the experiential session

Eligibility
Key inclusion criteria
Over 16 years of age
Can read and write in English fluently
Can provide written informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded from the study if they;
• Are allergic to tape or adhesives
• Have an inflammatory skin disorder
• Taking medication that affects the immune system (e.g. antibiotics or systemic corticosteroids)

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)
Randomisation to condition will be done by another researcher who is not conducting the experiment. Group allocation will be concealed from the participant and researcher until the time of the intervention. At this point, the researcher will open a sealed envelope which contains the randomised group allocation for that participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2020
Actual
Date of last participant enrolment
Anticipated
31/07/2020
Actual
Date of last data collection
Anticipated
31/07/2020
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment outside Australia
Country [1] 22313 0
New Zealand
State/province [1] 22313 0

Funding & Sponsors
Funding source category [1] 304871 0
University
Name [1] 304871 0
The University of Auckland
Country [1] 304871 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 305210 0
None
Name [1] 305210 0
Address [1] 305210 0
Country [1] 305210 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305279 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 305279 0
Ethics committee country [1] 305279 0
New Zealand
Date submitted for ethics approval [1] 305279 0
20/01/2020
Approval date [1] 305279 0
Ethics approval number [1] 305279 0

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

Contacts
Principal investigator
Name 99866 0
Prof Elizabeth Broadbent
Address 99866 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 99866 0
New Zealand
Phone 99866 0
+64 9 923 6756
Fax 99866 0
Email 99866 0
[email protected]
Contact person for public queries
Name 99867 0
Elizabeth Broadbent
Address 99867 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 99867 0
New Zealand
Phone 99867 0
+64 9 923 6756
Fax 99867 0
Email 99867 0
[email protected]
Contact person for scientific queries
Name 99868 0
Elizabeth Broadbent
Address 99868 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 99868 0
New Zealand
Phone 99868 0
+64 9 923 6756
Fax 99868 0
Email 99868 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Each individual’s data will be pooled together with the data of the other participants of the study and subjected to statistical analysis. Confidentiality will be maintained at all times. The results of any group analysis may be published in peer reviewed scientific journals, presented at conferences and used in a doctoral thesis. The raw videos will not be used in any outputs or be publicly available.


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.