Health TrialsbyHealthPanel

VR-PAT and fNIRS to Identify CNS Biomarkers of Pain

ConditionsAcute PainPediatric ALLProcedural PainBurns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorNationwide Children's Hospital

About this trial

This study aims to use functional near-infrared spectroscopy (fNIRS) to identify and quantify pain biomarkers during burn dressing changes and pain relief induced by virtual reality (VR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being treated for acute burn injury

Age 6-17 years, inclusive

Admitted to NCH burn unit for treatment

Have a dressing that requires daily changes over 3 days

Disqualifiers

Any wounds that may interfere with study procedures

Vision, hearing, or cognitive/motor impairments preventing valid administration of study measures

History of motion sickness, seizure disorder, dizziness, or migraine headaches precipitated by visual auras

Minors in foster care, prisoners, or currently pregnant

Trial design

Design model

Crossover

Treatments tested in this trial

  • VR-PAT

    Other intervention

    Virtual Reality Pain Alleviation Therapy (VR-PAT) played on a Pico Neo 3 Pro Eye device

Treatment groups

4 Participants
are divided into 2 treatment groups
Group A: VR-PATExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in brain activity

Mean change of hemoglobin oxygen (HBO2) concentration between VR and Control as detected by fNIRS.

Time frame
Assessed continuously throughout burn dressing changes (60 minutes) for the fNIRS study period (up to 5 days)

Secondary outcomes

1

Procedural pain during burn dressing changes

0-10 Numerical Rating Scale (NRS) (self-reported and caregiver-reported), 0(min)-10(max), with higher score indicating worse pain. Asked for worst pain, average pain, and time spent thinking about pain. Collected in both VR and Control group.

Time frame
Assessed within 15 minutes immediately after the burn dressing change about pain experienced during the procedure
2

Change in procedural anxiety

Modified Yale Preoperative Anxiety Scale (mYPAS) (observed by researcher), 23.33(min)-100(max), with higher scores denoting higher levels of anxiety.

Time frame
Assessed at 3 time points (30 minutes prior to procedure, immediately prior to procedure, and within 15 minutes immediately following the procedure) for each dressing change
3

Self-reported VR experience

0-10 Numerical Rating Scale (NRS) (self-reported - VR-PAT arm only), 0(min)-10(max), with higher score meaning better outcome. Asked for degree of realism, pleasure, and satisfaction with VR.

Time frame
Within 15 minutes immediately following burn dressing change when in VR-PAT group

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nationwide Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: