Virtual Reality Therapy to Improve Arthroplasty Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Highland Research, Development and Innovation Organisation
About this trial
Virtual reality (VR) has recently emerged as a non-medication-based method to manage anxiety. The patient wears a VR headset and is offered an immersive environment with hypnotic components with sound and imagery in a 3D environment. VR creates an immersive 3D environment and diverts attention away from worrying thoughts (anxiety) and pain and has been found useful to manage minor procedural pain and related anxiety.
This is a pilot feasibility trial to evaluate the effectiveness of VR in improving patient related outcomes (PROM) after joint replacement surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
NHS Highland patients
Able to provide written informed consent (remotely)
ASA Grade 1 and 2
Listed for elective surgery at NHSH NTC
Disqualifiers
Not able to provide written informed consent
Considered unsuitable by Clinician (with reason)
Vision /hearing difficulties which preclude interaction with immersive environment
Unable or unwilling to comply with study procedures and activities
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality Headset
DeviceUse of VR Headset for 20 minutes per day, from between 10 and 7 days pre surgery to 30 days post surgery
Blood Samples
Diagnostic testBlood samples will be collected from 5 participants randomly selected from each arm. Samples will be collected at baseline, day of surgery, 24 hours post surgery, 30 days post surgery and 90 days post surgery
Questionnaires
BehavioralBaseline and then FU data at 7, 14, 21, 30 and 90 days post-operative will be collected from participants via questionnaires
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VR Headset + QuestionnairesActive comparator 3 interventions
Group B: Usual Standard of Care + QuestionnairesActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients who refuse to participate in the study
This will be measured as a percentage of the total number of potential participants approached. This figure should not be greater than 70%.
Time frame
From 10 days pre surgery to 90 days post surgery2
Percentage of participants with complete questionnaires
This will be measured as a percentage of the total number of participants recruited. This figure should be greater than 80%.
Time frame
From 10 days pre surgery to 90 days post surgery3
Participant VR Headset Use Compliance Rate
This will be measured by recording the number of days the VR headset is used for 20 minutes per day over 37 days. (These compliance rates will be measured by data which is recorded by the VR headset itself).
Time frame
From 7 days pre surgery to 30 days post surgerySecondary outcomes
1
Number of patients approached for the study
Total number of potential participants approached to join the study
Time frame
From 10 days pre surgery to 90 days post surgery2
Number of participants recruited overall
Total number of participants recruited to the study
Time frame
From 10 days pre surgery to 90 days post surgery3
Percentage of patients excluded overall
This will be measured as a percentage of the total number of potential participants approached.
Time frame
From 10 days pre surgery to 90 days post surgery4
Participant VR Headset Use Compliance Rate - Pre Operative
This will be measured by recording the participant's use of the VR headset during the pre-operative period (number of days VR headset is used for 20 minutes per day over 7 days) (These compliance rates will be measured by data which is recorded by the VR headset itself)
Time frame
For 7 days pre day of surgeryOther outcomes
1
VR Headset Technical Complications Experienced
The number of VR headset technical complications experienced by participants will be recorded from feedback gathered at study visits
Time frame
From 7 days pre surgery to 30 days post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
NHS Highland Research, Development and Innovation Organisation
Lead sponsor
Healthy Mind
Collaborator
Source ClinicalTrials.gov