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Trial registered on ANZCTR


Registration number
ACTRN12621000442808
Ethics application status
Approved
Date submitted
3/03/2021
Date registered
16/04/2021
Date last updated
29/09/2022
Date data sharing statement initially provided
16/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effects of Relaxation on Wound Healing
Scientific title
The Effects of Relaxation on Stress and Skin Barrier Recovery
Secondary ID [1] 303556 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Healing 320944 0
Stress 321448 0
Condition category
Condition code
Skin 318748 318748 0 0
Other skin conditions
Injuries and Accidents 319211 319211 0 0
Other injuries and accidents
Mental Health 319212 319212 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Participating in a Brief Relaxation Session

Participants will be exposed to a tape-stripping procedure to measure skin barrier recovery (SBR), as an index of wound healing in humans. Tape-stripping is a non-invasive, simple and minimally painful procedure used to measure the rate at which the top layer of skin recovers after a disruption (i.e., SBR).

After the tape-stripping procedure, participants will be randomly assigned to one of three types of relaxation delivery methods: magazines (control), audiotapes, or a digital human. They will be asked to follow the instructions given by the audiotapes and digital human, or read magazines during a 20 minute recovery period to determine how each method influences the rate at which the skin barrier recovers. The researcher will not be in the room during this recovery period but will be nearby if participants need assistance. When alone in the room, participants will be video-recorded to assess and monitor adherence to the audiotapes and digital human, as well as whether they touched their wound.

Both the digital human and audiotapes condition follow the same relaxation script which includes deep breathing exercises and guided progressive muscle relaxation. This script is based on the script used in a previous study looking at relaxation before and after tape-stripping (Robinson et al., 2015).

The relaxation interventions will only be delivered in a one-off, 90-minute session at the Clinical Research Centre on Grafton Campus at the University of Auckland.

Digital humans are a form of embodied conversational agent (ECA) that includes a computer-based dialogue system and a virtual embodiment (Cassell et al., 2000; Sagar et al., 2014). A virtual embodiment refers to an animated face or body presented on a computer screen. Digital humans use artificial intelligence in the form of neural networks to learn and respond to user input, such as human facial expressions, movement, and speech (Loveys et al., 2020; Sagar et al., 2016). For this study, a digital human will deliver the relaxation script to participants on the computer for 20 minutes. During this time, the digital human will introduction themselves before guiding participants through deep breathing and progressive muscle relaxation exercises.

For the audiotapes condition, participants will be asked to listen to the audio recording of a human voice on the computer which will passively guide them through the relaxation script for 20 minutes.
Intervention code [1] 319861 0
Treatment: Other
Comparator / control treatment
The control condition will not be provided with a relaxation intervention, only magazines while participants are told to wait and see how their skin recovers. Magazines have been used as a control condition in previous studies as a neutral activity to prevent participants from becoming too bored (Robinson et al., 2017).
Control group
Active

Outcomes
Primary outcome [1] 326708 0
Change in trans-epidermal water loss (TEWL), measured by the Tewameter TM 300.

The TWEL readings from the three time-points determines the final SBR value for each site.
Timepoint [1] 326708 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [1] 392428 0
Changes in salivary cortisol
Timepoint [1] 392428 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [2] 392429 0
Changes in salivary alpha-amylase
Timepoint [2] 392429 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [3] 392430 0
Changes in skin conductance: Participants will wear a wrist sensor (Empatica E4) which will continuously measure blood volume pulse for the duration of the session. A button will be pressed to timestamp the continuous data at each of the three time points. Electrodermal activity will be used to measure changes in electrical resistance in the skin (skin conductance)
Timepoint [3] 392430 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [4] 392431 0
Changes in heart rate: Participants will wear a wrist sensor (Empatica E4) which will continuously measure blood volume pulse for the duration of the session. A button will be pressed to timestamp the continuous data at each of the three time points. Blood volume pulse will be converted into a measure of heart rate.
Timepoint [4] 392431 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [5] 392432 0
Changes in current stress levels as measured by 100mm visual analogue scales
Timepoint [5] 392432 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [6] 392433 0
Changes in current anxiety levels measured by a 100mm visual analogue scale
Timepoint [6] 392433 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [7] 392434 0
Changes in current relaxation levels measured by a 100mm visual analogue scale
Timepoint [7] 392434 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [8] 392435 0
Changes in current pain levels measured by a 100mm visual analogue scales
Timepoint [8] 392435 0
Baseline, immediately post tape-stripping and immediately post-recovery
Secondary outcome [9] 392436 0
Relaxation Session Feedback as measured by two 100mm visual analogue scales and two open-ended questions. The visual analogue scales will measure levels of satisfaction and relaxation after the relaxation session. The open-ended questions have been adapted from Loveys and colleague's feasibility study investigating digital humans and CBSM (in prep).
Timepoint [9] 392436 0
Immediately post recovery

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they:
- Are over the age of 18
- Can speak, read, and write in fluent English.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they:
- Are allergic to adhesive tape
- Have any inflammatory skin diseases/immunological-related health problems
- Are taking medication that affects immune functioning (e.g., prednisone)
- Are pregnant
- Over the age of 60
- Have hearing difficulties or vision loss.

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)
Participants will be randomised to one of three conditions in advance by a researcher not involved in the study. After the tape- stripping procedure, group allocation will be revealed after the researcher opens the sealed, opaque envelope containing each participant's assigned condition. After this, the researcher and participant will no longer be blinded to the conditions
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a random online number generator on the computer.
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
Power analysis:
Using a f value of .275, power of .80 and a of .05, with three groups and five covariates, the required sample size is 131. Like previous tape-stripping studies, this will be increased by 20% to account for possible errors in the TEWL measurements (Law et al., 2020), giving a final sample size of 159 participants (53 participants per group).

Outcome analysis:

A between groups ANOVA will be conducted to assess differences in SBR between conditions, in addition to an ANCOVA (to control for covariates related to SBR rates such as age, number of strips of tape, and levels of skin barrier impairment; Law et al., 2020; Robinson et al., 2017). For the secondary outcomes (biological, physiological, and psychological measures), mixed factorial ANOVAs will be conducted to analyse the main and interaction effects of time-point and condition. The data will be checked for violations of the normality assumption before analysis. To investigate whether psychological and physiological stress levels mediate the relationship between the delivery condition and SBR, separate exploratory mediational analyses will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/05/2021
Actual
26/05/2021
Date of last participant enrolment
Anticipated
29/10/2021
Actual
22/02/2022
Date of last data collection
Anticipated
29/10/2021
Actual
22/02/2022
Sample size
Target
159
Accrual to date
Final
159
Recruitment outside Australia
Country [1] 23495 0
New Zealand
State/province [1] 23495 0
Auckland

Funding & Sponsors
Funding source category [1] 307979 0
University
Name [1] 307979 0
The University of Auckland
Country [1] 307979 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] 308717 0
None
Name [1] 308717 0
Address [1] 308717 0
Country [1] 308717 0
Other collaborator category [1] 281677 0
Commercial sector/Industry
Name [1] 281677 0
Soul Machines
Address [1] 281677 0
Soul Machines Ltd
106 Customs Street West
Auckland CBD
Auckland 1142
Country [1] 281677 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307970 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 307970 0
Ethics committee country [1] 307970 0
New Zealand
Date submitted for ethics approval [1] 307970 0
25/01/2021
Approval date [1] 307970 0
03/03/2021
Ethics approval number [1] 307970 0

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

Contacts
Principal investigator
Name 109090 0
Prof Elizabeth Broadbent
Address 109090 0
Department of Psychological Medicine,
The University of Auckland,
Faculty of Medical and Health Sciences Building 507, Grafton
Auckland 1023
Country 109090 0
New Zealand
Phone 109090 0
+64 9 923 6756
Fax 109090 0
Email 109090 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 109091 0
Elizabeth Broadbent
Address 109091 0
Department of Psychological Medicine,
The University of Auckland,
Faculty of Medical and Health Sciences Building 507, Grafton
Auckland 1023
Country 109091 0
New Zealand
Phone 109091 0
+64 9 923 6756
Fax 109091 0
Email 109091 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 109092 0
Elizabeth Broadbent
Address 109092 0
Department of Psychological Medicine,
The University of Auckland,
Faculty of Medical and Health Sciences Building 507, Grafton
Auckland 1023
Country 109092 0
New Zealand
Phone 109092 0
+64 9 923 6756
Fax 109092 0
Email 109092 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
Due to ethics and participant privacy, we must keep all data anonymous and confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10852Study protocol    381508-(Uploaded-02-03-2021-10-59-31)-Study-related document.pdf
10853Informed consent form    381508-(Uploaded-02-03-2021-11-00-04)-Study-related document.pdf
10863Ethical approval    381508-(Uploaded-03-03-2021-11-33-07)-Study-related document.pdf



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.