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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Wound Healing

Stress

Condition category

Condition code

Skin

Other skin conditions

Injuries and Accidents

Other injuries and accidents

Mental Health

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]

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]

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]