Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000953235
Ethics application status
Approved
Date submitted
1/06/2018
Date registered
6/06/2018
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Date results information initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Environmental Enrichment on Stress and Skin Healing in Healthy Participants
Scientific title
The Effect of Environmental Enrichment on Stress and Skin Healing in Healthy Participants
Secondary ID [1] 294858 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Healing 307806 0
Condition category
Condition code
Skin 306855 306855 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 laboratory stress task (the Trier Social Stress Task) and to a tape stripping procedure which removes the top-layer of skin through the repeated application of tape. 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 3 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 recovery period.
There will be two different environmental enrichment items and a control group. The enrichment items include; relaxing music which will be presented using a CD player and headphones and 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.
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
Intervention code [1] 301168 0
Treatment: Other
Comparator / control treatment
The control group will have no form of enrichment during the 30 minute recovery period and will instead be asked to sit and wait for 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 305848 0
Change in trans-epidermal water loss (TEWL) as measured using the Tewameter TM 300
Timepoint [1] 305848 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [1] 346758 0
Changes in salivary cortisol
Timepoint [1] 346758 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [2] 346759 0
Mood as measured using a Modified version of the actual affect sub scale of the Affect Valuation Index
Timepoint [2] 346759 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [3] 346760 0
Changes in current stress levels as measured using 100mm visual analogue scales
Timepoint [3] 346760 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [4] 346762 0
Changes in salivary alpha-amylase
Timepoint [4] 346762 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [5] 346763 0
Changes in current anxiety levels as measured using 100mm visual analogue scales
Timepoint [5] 346763 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [6] 346764 0
Changes in current pain levels as measured using 100mm visual analogue scales
Timepoint [6] 346764 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [7] 346765 0
Changes in current relaxation levels as measured using 100mm visual analogue scales
Timepoint [7] 346765 0
Baseline, Post-Stress task, Post-Tape stripping and post-intervention
Secondary outcome [8] 347623 0
Changes in current mood as measured by the PANAS Scale
Timepoint [8] 347623 0
Baseline, Post-Stress task, 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
Participated in an earlier study of the same topic

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=87. This sample size was increased by 20% due to the possible error rate of TEWL measurement, giving a total required sample size of 105.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2018
Actual
26/06/2018
Date of last participant enrolment
Anticipated
9/11/2018
Actual
19/12/2018
Date of last data collection
Anticipated
9/11/2018
Actual
19/12/2018
Sample size
Target
105
Accrual to date
Final
105
Recruitment outside Australia
Country [1] 10391 0
New Zealand
State/province [1] 10391 0
Auckland

Funding & Sponsors
Funding source category [1] 299447 0
University
Name [1] 299447 0
The University of Auckland
Country [1] 299447 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] 298741 0
None
Name [1] 298741 0
Address [1] 298741 0
Country [1] 298741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300353 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 300353 0
Office of the Vice Chancellor, Research Office
Alfred Nathan House, The University of Auckland
Private Bag 92019, Auckland 1142
Ethics committee country [1] 300353 0
New Zealand
Date submitted for ethics approval [1] 300353 0
03/04/2018
Approval date [1] 300353 0
02/05/2018
Ethics approval number [1] 300353 0
021058

Summary
Brief summary
The purpose of this study is to investigate whether different forms of environmental enrichment (EE) can improve wound healing after a laboratory stress task. The current study will estimate wound healing using the tape stripping model to assess skin barrier recovery.. During the experimental session, participants will be randomised to one of three groups which will either receive an EE item or not (music, Paro or control group).
The hypothesis for this study states that the two EE groups (Paro and music groups) will have improved wound healing throughout the session, as assessed by trans-epidermal water loss (TEWL) measures, than the control group who does not receive a form of EE. The EE groups are also expected to have improved mood and stress scores as assessed by the questionnaires after interacting with their form of EE when compared to the control group.
There are no specific hypotheses for any possible differences in skin barrier recovery or mood and stress for the three EE groups as no research has yet to directly compare these forms of EE.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83370 0
A/Prof Elizabeth Broadbent
Address 83370 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 83370 0
New Zealand
Phone 83370 0
+649 373 7599 Ext. 86756
Fax 83370 0
Email 83370 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 83371 0
A/Prof Elizabeth Broadbent
Address 83371 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 83371 0
New Zealand
Phone 83371 0
+649 373 7599 Ext. 86756
Fax 83371 0
Email 83371 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 83372 0
A/Prof Elizabeth Broadbent
Address 83372 0
Department of Psychological Medicine,
University of Auckland,
Level 12, Auckland Hospital Support Building, Grafton,
Private Bag 92019, Auckland, 1142
Country 83372 0
New Zealand
Phone 83372 0
+649 373 7599 Ext. 86756
Fax 83372 0
Email 83372 0
e.broadbent@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual data will be shared to keep anonymity


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.