An interventional study of Virtual Reality Headset and Blood Samples in Surgical, Anxiety and Pain Management, sponsored by NHS Highland Research, Development and Innovation Organisation. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by NHS Highland Research, Development and Innovation Organisation · Not applicable, Interventional, and Supportive care
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.
Psychological factors, (anxiety in particular) link into the biological human stress response systems and can thus have an important bearing on perioperative outcomes. Current pharmacological and non- pharmacological interventions to manage anxiety are not as effective as desired due to a multitude of reasons (side effects, staffing requirements such as psychologists, expense or lack efficacy).
Addressing psychological factors like perioperative anxiety with a relatively easy to use, non-invasive technique such as Virtual Reality (VR) is likely to improve PROM (Patient Reported Outcome Measures). Recently, Virtual Reality (VR) has emerged as a non-pharmacological method to manage preoperative anxiety. VR is theorised to decrease perioperative pain and anxiety by diverting attention away from nociception stimulus, extinction of negative expectancy and fear towards pain and modulating pain related neuroendocrine stress responses. VR thus is able to improve PROM (Patient Reported Outcome Measures) and also improve post-operative pain /opioid use, length of stay in hospital and joint arthroplasty complication rates.
The researchers aim to perform a pilot feasibility study in preparation for the multi-centre randomised control trial that will follow. The primary objective of the pilot feasibility trial will be to test the acceptability, level of adherence to the trial protocol by patients, the ease with which the intervention can be implemented and estimates of the effect size/variability that should be used in the statistical design of the main study.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →NHS Highland Research, Development and Innovation Organisation is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Virtual Reality Headset · Diagnostic Test: Blood Samples · Behavioral: Questionnaires
Diagnostic Test: Blood Samples · Behavioral: Questionnaires
Use of VR Headset for 20 minutes per day, from between 10 and 7 days pre surgery to 30 days post surgery
Blood 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
Baseline and then FU data at 7, 14, 21, 30 and 90 days post-operative will be collected from participants via questionnaires
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 surgery
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 surgery
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 surgery
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 surgery
Number of participants recruited overall
Total number of participants recruited to the study
Time frame: From 10 days pre surgery to 90 days post surgery
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 surgery
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 surgery
Participant VR Headset Use Compliance Rate - Post Operative
This will be measured by recording the participant's use of the VR headset during the post-operative period (number of days VR headset is used for 20 minutes per day over 30 days) (These compliance rates will be measured by data which is recorded by the VR headset itself)
Time frame: From days 1-30 post surgery
Percentage of participants who withdraw during the trial
This will be measured as a percentage of the total number of participants recruited.
Time frame: From 10 days pre surgery to 90 days post surgery
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 surgery
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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NHS Highland Research, Development and Innovation Organisation