Using an Interactive Virtual Reality System to Distract Burns Patients During Burn Treatments

NCT03827304 | Completed Results

• 1 other identifier: AA8434
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The aims are VR to reduced perceived pain and anxiety during painful dressings changes in a small sample of burns patients;

• to measure the impact of the interventions on objective indicators of pain and distress during dressing changes within the small sample
• to assess pain medication use during virtual reality interventions
• to compare the above effects and experiences across two conditions within each participant: an active version of a virtual reality intervention, and a 'control' condition of no intervention;
• to assess the perceived usability, acceptability, engagement with and enjoyment of the virtual reality intervention to patients
• to consider the apparent feasibility of the virtual reality intervention within a Burns Unit inpatient setting during painful dressing changes 4. Design This is an exploratory feasibility study with a small clinical sample of burns patients and staff caring for them, in a single burns unit setting, employing mixed methods and a repeated measures design to achieve the aims set out above.

Conditions

Burns

Keywords

Burns; Virtual Reality; Qualitative

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  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.

  Assessed 1 time during dressing with and without VR

Secondary Outcomes (1)

• Anxiety Scores

  Assessed 1 time during dressing with and without VR

Study Arms (1)

Burns patients

EXPERIMENTAL

This is the group of burns patients that use receive the intervention with the Virtual Reality pain distraction game during the dressing change.

Device: Virtual Reality Distraction for Burns patients

Interventions

Virtual Reality Distraction for Burns patients DEVICE

Patients wore a VR headset while undergoing a burns dressing change

Also known as: Burns Dressings Change VR distraction

Burns patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult burns in-patients
• receiving regular dressing changes during the study period

You may not qualify if:

• active PTSD or psychotic symptoms
• high levels of distress
• head and neck burns

Sponsors & Collaborators

• Sheffield Hallam University: lead
• National Institute for Health Research, United Kingdom: collaborator
• University of Sheffield: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Ivan Phelan

Sheffield, South Yorkshire, S1 2NU, United Kingdom

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

• Title: Ivan Phelan
• Organization: Sheffield Hallam University

i.phelan@shu.ac.uk

+44 114 225 6955

Study Officials

• Ivan Phelan, MSc

  Sheffield Hallam University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study aimed to explore: * patient and staff perceptions of the effect of active and passive VR on perceived pain and anxiety during painful dressings changes; * patient perceptions of the usability, acceptability, engagement with and enjoyment of active and passive VR scenarios; * staff perceptions about the usability and implications of the VR technology within a Burns Unit inpatient setting. Methods: This was a small-scale qualitative usability study, employing qualitative methods to intervention development and feasibility work. Patients: Participants were adult inpatients at the local Burns Unit who were undergoing regular dressing changes during the study period. Exclusion criteria included head and neck burns, wound infection, current diagnosis of PTSD, active psychotic symptoms or high levels of distress. Suitable patients were briefly introduced to the study and supplied with a full information sheet, with details about aims, procedures and rights.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 1, 2019
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 25, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)