Trial Outcomes & Findings for Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments (NCT NCT03827304)

NCT ID: NCT03827304

Last Updated: 2025-03-25

Results Overview

Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Pain was measured on a scale range 0-100 in which 0 is no pain and 100 represents the greatest levels imaginable of pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: Assessed 1 time during dressing with and without VR
• Results posted on: 2025-03-25

Participant Flow

Recruitment will be based on purposive opportunity sampling. People who meet the criteria and are receiving in-patient care during the period of the study.

Participant milestones

Measure	Burns Dressings Patients Virtual Reality pain distraction games scenarios Virtual Reality Distraction from Burn Pain: Patients wore a VR headset while undergoing a burns dressing change
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Burns Dressings Patients n=5 Participants Virtual Reality pain distraction games scenarios Virtual Reality Distraction from Burn Pain: Patients wore a VR headset while undergoing a burns dressing change
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.2 years STANDARD_DEVIATION 19.68 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United Kingdom	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed 1 time during dressing with and without VR

Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Pain was measured on a scale range 0-100 in which 0 is no pain and 100 represents the greatest levels imaginable of pain.

Outcome measures

Measure	Burns Patients n=5 Participants This is the group of burns patients that use receive the intervention with the Virtual Reality pain distraction game during the dressing change. Virtual Reality Distraction for Burns patients: Patients wore a VR headset while undergoing a burns dressing change
Pain Scores Pain (with VR)	44.0 score on a scale Standard Deviation 17.1
Pain Scores Pain (without VR)	52.50 score on a scale Standard Deviation 15.54

SECONDARY outcome

Timeframe: Assessed 1 time during dressing with and without VR

Using a thermometer scale (Sheffield Burns Unit Psychosocial Screening Tool). Anxiety was measured on a scale range 0-100 in which 0 is no anxiety and 100 represents the greatest levels imaginable of anxiety.

Outcome measures

Measure	Burns Patients n=5 Participants This is the group of burns patients that use receive the intervention with the Virtual Reality pain distraction game during the dressing change. Virtual Reality Distraction for Burns patients: Patients wore a VR headset while undergoing a burns dressing change
Anxiety Scores Anxiety (with VR)	36.00 score on a scale Standard Error 33.61
Anxiety Scores Anxiety (without VR)	56.25 score on a scale Standard Error 31.51

Adverse Events

Burns Dressings Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ivan Phelan

Sheffield Hallam University

Phone: +44 114 225 6955

Email: i.phelan@shu.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place