SurgicalVROOMNCT07872670
Virtual Reality Therapy to Improve Arthroplasty Outcomes
A study testing Virtual Reality Headset, Blood Samples and Questionnaires in people with Surgical and Anxiety, run by NHS Highland Research, Development and Innovation Organisation at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical, Anxiety, Pain Management
- What is being tested?
- Virtual Reality Headset, Blood Samples and Questionnaires
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NHS Highland patients
- Able to provide written informed consent (remotely)
- ASA Grade 1 and 2
- Listed for elective surgery at NHSH NTC
- Adults>18 years undergoing joint arthroplasty surgery (hip and knee) will be included
- Fluent in English
Show all 9Show fewer
- Able to receive and write emails
- Willing to comply with study protocols/training
- Access to Wi-Fi to undertake VRIT and complete questionnaires online
Who cannot join
- 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
- Participation in another interventional trial which undermines the scientific basis of the study
- Have a history of alcohol or substance abuse or Parkinson's disease or Multiple Sclerosis or Labyrinthitis (Ménière's disease), history of seizures, motion sickness or dementia
Show all 9Show fewer
- Non NHS Highland patients
- Photosensitive epilepsy
- Patients with surgery scheduled for a Friday
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
National Treatment Centre - Highland
Inverness, Highlands, IV2 5NA
Devjit Srivastava, +44 1463 705350, dev.srivastava@nhs.scot
About this study
Official title: Pilot Randomised Controlled Trial of Virtual Reality Immersive Therapy (VRIT) in Addition to Usual Care Compared to Usual Care in Patients Undergoing Joint Arthroplasty - VROOM 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.
Read the detailed description
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.
- Conditions
- Surgical, Anxiety, Pain Management, Joint (Knee or Hip Replacement)
- Being tested
- Virtual Reality Headset, Blood Samples, Questionnaires
- Keywords
- Psychology, Surgery, Anxiety, Perioperative, Virtual reality, Joint arthroplasty
- Medical subject headings
- Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
Use of VR Headset for 20 minutes per day, from between 10 and 7 days pre surgery to 30 days post surgery
Blood SamplesDiagnostic test
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
QuestionnairesBehavioural
Baseline and then FU data at 7, 14, 21, 30 and 90 days post-operative will be collected from participants via questionnaires
| Study group | Role | What they receive |
|---|---|---|
| VR Headset + Questionnaires | Active comparator | Not described Receives: Device: Virtual Reality Headset; Diagnostic Test: Blood Samples; Behavioral: Questionnaires |
| Usual Standard of Care + Questionnaires | Active comparator | Not described Receives: Diagnostic Test: Blood Samples; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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).
Measured: From 7 days pre surgery to 30 days post surgery
Secondary outcomes (6)
Number of patients approached for the study
Total number of potential participants approached to join the study
Measured: From 10 days pre surgery to 90 days post surgery
Number of participants recruited overall
Total number of participants recruited to the study
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: From 10 days pre surgery to 90 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start5 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Highland Research, Development and Innovation Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Healthy Mind
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872670
- Sponsor's protocol ID
- Highland 1955
- Other IDs
- 339185, 25/SC/0132
- Acronym
- VROOM
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomised Controlled Trial of Virtual Reality Immersive Therapy (VRIT) in Addition to Usual Care Compared to Usual Care in Patients Undergoing Joint Arthroplasty - VROOM Trial
- ClinicalTrials.gov ID
- NCT07872670
- Acronym / sponsor ID
- VROOM / Highland 1955
- Conditions
- Surgical, Anxiety, Pain Management, Joint (Knee or Hip Replacement)
- Keywords
- Psychology, Surgery, Anxiety, Perioperative, Virtual reality, Joint arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NHS Highland Research, Development and Innovation OrganisationUniversity, hospital or other
- Collaborators
- Healthy Mind
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR Headset + Questionnaires | Active comparator | Device: Virtual Reality Headset, Diagnostic Test: Blood Samples, Behavioral: Questionnaires |
| Usual Standard of Care + Questionnaires | Active comparator | Diagnostic Test: Blood Samples, Behavioral: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- NHS Highland patients
- Able to provide written informed consent (remotely)
- ASA Grade 1 and 2
- Listed for elective surgery at NHSH NTC
- Adults>18 years undergoing joint arthroplasty surgery (hip and knee) will be included
Key exclusion criteria (9 listed)
- 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
- Participation in another interventional trial which undermines the scientific basis of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality HeadsetUse of VR Headset for 20 minutes per day, from between 10 and 7 days pre surgery to 30 days post surgery | Device | VR Headset + Questionnaires |
| Blood SamplesBlood 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 | Diagnostic test | Usual Standard of Care + Questionnaires, VR Headset + Questionnaires |
| QuestionnairesBaseline and then FU data at 7, 14, 21, 30 and 90 days post-operative will be collected from participants via questionnaires | Behavioural | Usual Standard of Care + Questionnaires, VR Headset + Questionnaires |
Primary outcome
Percentage of patients who refuse to participate in the study
Time frame: From 10 days pre surgery to 90 days post surgery
This will be measured as a percentage of the total number of potential participants approached. This figure should not be greater than 70%.
Percentage of participants with complete questionnaires
Time frame: From 10 days pre surgery to 90 days post surgery
This will be measured as a percentage of the total number of participants recruited. This figure should be greater than 80%.
Participant VR Headset Use Compliance Rate
Time frame: From 7 days pre surgery to 30 days post surgery
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).
6 secondary outcomes
Number of patients approached for the study
Time frame: From 10 days pre surgery to 90 days post surgery
Number of participants recruited overall
Time frame: From 10 days pre surgery to 90 days post surgery
Percentage of patients excluded overall
Time frame: From 10 days pre surgery to 90 days post surgery
Participant VR Headset Use Compliance Rate - Pre Operative
Time frame: For 7 days pre day of surgery
Participant VR Headset Use Compliance Rate - Post Operative
Time frame: From days 1-30 post surgery
Percentage of participants who withdraw during the trial
Time frame: From 10 days pre surgery to 90 days post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Headset, Blood Samples and Questionnaires in people with Surgical and Anxiety, run by NHS Highland Research, Development and Innovation Organisation at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devjit Srivastava (+44 1463 705350, dev.srivastava@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who refuse to participate in the study (time frame: From 10 days pre surgery to 90 days post surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.