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Validating the use of pain psychology therapy delivered through Virtual Reality in healthy adults without acute or chronic pain

Validation of a novel Virtual Reality-delivered pain psychology therapy program: a randomised controlled study in healthy adults without acute or chronic pain

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001087943
Enrollment
40
Registered
2020-10-20
Start date
2021-02-01
Completion date
2021-04-01
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to evaluate the validity of a pain psychology therapy delivered by virtual reality to volunteers, by measuring metrics of presence and factual information recall. Who is it for? You may be eligible for this study if you are 18 years or older, healthy without acute or chronic pain Study details: Participants will be randomly allocated (50/50 chance) to either the intervention group or control group. The intervention group will receive 2 x 30 min modules of VR-delivered pain therapy. This will be done in one session totaling 70 minutes - 30 minutes for one module, 10 minutes rest break and 30 minutes for the other module. The pain therapy program is self-contained and consists of 2 modules: (1) Progressive muscle relaxation (2) Guided pain visualisation Participants will be required to answer questionnaires about their presence whilst using the VR hardware immediately after the session is complete. They will also be asked to complete a set of multiple choice questions designed to test information recall immediately after the session and also 2 weeks after the session. It is hoped that this validation study will strengthen the evidence base for clinical use of the VR-delivered therapy.

Interventions

Name: VR-delivered pain therapy Participants in the intervention arm will receive 2 x 30 min modules of pain therapy delivered by virtual reality hardware. The pain therapy program is self contained and consists of 2 modules (1) progressive muscle relaxation and (2) guided pain visualisation. Each module takes a maximum of 30 minutes duration. Participants will be asked to undertake both therapies consecutively, with a 10 minute rest break. The VR session will occur in the UNSW simulation la

Name: VR-delivered pain therapy Participants in the intervention arm will receive 2 x 30 min modules of pain therapy delivered by virtual reality hardware. The pain therapy program is self contained and consists of 2 modules (1) progressive muscle relaxation and (2) guided pain visualisation. Each module takes a maximum of 30 minutes duration. Participants will be asked to undertake both therapies consecutively, with a 10 minute rest break. The VR session will occur in the UNSW simulation laboratory at Liverpool Hospital. Each participant will be allocated one session, lasting 70 minutes long. Each participant will undergo their session individually. The pain therapy program is interactive and video-based. It is delivered using voice-overs and virtual avatars, who teach each therapy using step-by-step exercises reinforced with graphical information. Participants interact with these avatars using their hand-motion controllers. The interaction between the participant and the VR-delivered pain therapy does not require external intervention from a researcher. However, the view experienced by the participant is projected onto an external TV. This will be monitored by a researcher who can intervene if necessary. In order to monitor adherence to the intervention, a session attendance checklist will be administered, and follow-up emails will be sent to all participants.

Sponsors

South Western Sydney LHD
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

- Adult (greater than or equal to 18yo) participants, healthy without acute or chronic pain

Exclusion criteria

- Insufficient written English language proficiency to complete questionnaires. - Insufficient verbal English language proficiency to interact with the VR software avatar. - Psychological or psychiatric illness not stabilised with therapy and/or medications. - Uncertainty or unable to be followed up for subsequent two months after recruitment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026