Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001154392
Ethics application status
Approved
Date submitted
4/08/2017
Date registered
8/08/2017
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Environmental Enrichment on Wound Healing in Healthy Participants
Scientific title
The Effects of Environmental Enrichment on Wound Healing in Healthy Participants
Secondary ID [1] 292585 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Healing 304256 0
Condition category
Condition code
Skin 303612 303612 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Interaction with Environmental Enrichment Item
Participants will be exposed to a tape stripping procedure which removes the top-layer of skin through the repeated application of tape. The participant will have 20-40 pieces of tape applied and gently removed from their forearm. This procedure is a non-invasive and minimally painful method to assess wound healing in humans.
After the tape-stripping procedure has been performed, participants will be randomised to 1 of 4 conditions where they will (or will not) receive a different type of enrichment item. They will be asked to interact with this enrichment item during a 30 minute period, in order to examine whether the enrichment item improved wound healing over this period. There will be three different environmental enrichment items and a control group. The enrichment items include; (1) relaxing music which will be presented using a CD player and headphones, (2) materials in the form of soft blankets and pillows and (3) a seal companion robot, Paro. The Paro seal robot proposed for one of the conditions is a therapeutic robot designed to provide a safer alternative to animal-assisted therapy. Paro uses sensors to respond to human contact in a socially supportive and comforting way and has a soft fur coat to provide tactile comfort All groups, including the control group, will also be provided with magazines to read. Reading magazines has been used previously as a control condition in similar trials.
The researcher (a doctoral candidate) will introduce the item to the participants and explain what is going to happen. Participants will be asked to interact with their assigned condition over a 30 minute period where the researcher is not in the room. They will be video-recorded during this period to ensure that they have interacted with their assigned item and have not interfered with their wound.
The intervention will only be delivered to the participants in a one-off 30 minute period. This procedure will occur in a research clinic at the University of Auckland
Intervention code [1] 298792 0
Treatment: Other
Comparator / control treatment
The active control group will receive some magazines to read through during the 30 minute time period and will not receive any other form of enrichment item.
Control group
Active

Outcomes
Primary outcome [1] 302965 0
Change in trans-epidermal water loss (TEWL) as measured using the Tewameter TM 300
Timepoint [1] 302965 0
Baseline, Post-Tape stripping and post-intervention
Secondary outcome [1] 337578 0
Changes in salivary cortisol
Timepoint [1] 337578 0
Baseline, post-tape stripping and post-intervention
Secondary outcome [2] 337579 0
Mood as measured using a Modified version of the actual affect sub scale of the Affect Valuation Index
Timepoint [2] 337579 0
Baseline, Post-tape stripping and Post-Intervention
Secondary outcome [3] 337633 0
Changes in salivary alpha-amylase
Timepoint [3] 337633 0
Baseline, Post-tape stripping and post- intervention
Secondary outcome [4] 337634 0
Changes in current stress levels as measured using 100mm visual analogue scales
Timepoint [4] 337634 0
Baseline, Post-tape stripping and post- intervention
Secondary outcome [5] 337635 0
Changes in current anxiety levels as measured using 100mm visual analogue scales
Timepoint [5] 337635 0
Baseline, Post-tape stripping and post- intervention
Secondary outcome [6] 337636 0
Changes in current pain levels as measured using 100mm visual analogue scales
Timepoint [6] 337636 0
Baseline, Post-tape stripping and post- intervention
Secondary outcome [7] 337637 0
Changes in current relaxation levels as measured using 100mm visual analogue scales
Timepoint [7] 337637 0
Baseline, Post-tape stripping and post- intervention

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
Are allergic to tape or adhesives
Have an inflammatory skin disorder
Are taking medication that affects the immune system (e.g. antibiotics or corticosteroids)
Are pregnant
Cannot write or read in English fluently
Are under 16 years of age

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
The sample size required for this study was calculated using the programme G*Power. The analysis was conducted using a 4(conditions) x 3(time points) mixed design analysis of variance (ANOVA). A power level of .80 and alpha level of .05 were chosen as they are the recommended parameters. An effect size of F= 0.28 was calculated using the results of a similar tape-stripping study which also examined the changes in trans-epidermal water loss (TEWL) due to an intervention, in this case a relaxation intervention (Robinson et al., 2015). These parameters led to a required total sample size of at least N=100. This sample size was increased by 20% due to the possible error rate of TEWL measurement.
Mixed factorial Analysis of Variance (ANOVAs) will be used to analyse the interaction and main effects of condition (control, music, comfort and Paro) and time-point (baseline, post-tape stripping and post-intervention) on TEWL.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/08/2017
Actual
21/08/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
20/04/2018
Date of last data collection
Anticipated
1/12/2017
Actual
20/04/2018
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 9123 0
New Zealand
State/province [1] 9123 0
Auckland

Funding & Sponsors
Funding source category [1] 297161 0
University
Name [1] 297161 0
The University of Auckland
Country [1] 297161 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] 296180 0
None
Name [1] 296180 0
Address [1] 296180 0
Country [1] 296180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298329 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 298329 0
Ethics committee country [1] 298329 0
New Zealand
Date submitted for ethics approval [1] 298329 0
15/06/2017
Approval date [1] 298329 0
28/07/2017
Ethics approval number [1] 298329 0
019556

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

Contacts
Principal investigator
Name 76738 0
A/Prof Elizabeth Broadbent
Address 76738 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 76738 0
New Zealand
Phone 76738 0
+64 9 373 7599 Ext. 86756
Fax 76738 0
Email 76738 0
[email protected]
Contact person for public queries
Name 76739 0
Elizabeth Broadbent
Address 76739 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 76739 0
New Zealand
Phone 76739 0
+64 9 373 7599 Ext. 86756
Fax 76739 0
Email 76739 0
[email protected]
Contact person for scientific queries
Name 76740 0
Elizabeth Broadbent
Address 76740 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 76740 0
New Zealand
Phone 76740 0
+64 9 373 7599 Ext. 86756
Fax 76740 0
Email 76740 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
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