AnxietyNCT06292663
Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety?
A study testing Virtual Reality in people with Anxiety and Surgery, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Mar 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Scheduled for total knee arthroplasty
- Scheduled for spinal anesthesia
- Age of 18 or above
- Ability to understand the trial protocol, risks, and benefits and provide signed informed consent
Who cannot join
- Inability to read and understand Danish
- Uncooperativeness (as judged by investigators)
- Claustrophobia or fear of small spaces
- Disorders that prevent the person from wearing a VR device
- Highly visually or auditive impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? A Randomized Controlled Trial and Patient Interviews
The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:
- Can preoperative information through a VR headset lower the patients preoperative anxiety?
- Can VR information make the patients more ready for surgery. Painscore will also be collected.
Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.
If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain
Read the detailed description
Knee osteoarthritis (OA) causes pain, disability and poor quality of life in the elderly. Consequently, it can severely affect people's quality of life and physical function. International guidelines recommend exercise therapy alongside patient education and weight management (if needed) as first-line treatment for all individuals with knee OA. However, more than 1,000,000 TKA procedures are performed annually worldwide, and with aging populations and an increase in obesity, this number is expected to increase markedly4. Although TKA is generally considered an effective treatment option, up to 20% of patients are not fully satisfied after surgery5. Spinal anesthesia is commonly used during primary TKA given the purported safety benefits, quicker immediate postoperative recovery, decreased intraoperative bleeding, and lower transfusion rates when compared to general anesthesia. To help the patient feel more comfortable and relaxed during a procedure, administration of sedative medication titrated by the anesthetist is common practice. Despite a low rate of complications associated with spinal anesthesia compared to general anesthesia, it is important to acknowledge that complications can still occur.
Virtual Reality (VR) demonstrates signs as a promising tool to support healthcare, including mentally preparing the patient for a surgical procedure. Preoperative readiness, expectations, anxiety, and pain perception are crucial to the patient's surgical experiences. VR can immerse patients into a virtual environment and distract patients from e.g., unpleasant sounds, sights, and feelings. Integrating VR into preoperative care has shown the potential to offer several advantages, such as promoting patients' distraction, knowledge, and information. However, harms have been reported such as cyber sickness but only in few cases among older adult patients.
Offering a controlled environment where patients can familiarize themselves with the surgical process through VR shown on a head-mounted display (HMD) and with sound reduction headphones provides them an opportunity to explore, e.g., the operation theater, waiting area, and PACU.
All this can foster a sense of confidence and increased readiness and lead to an overall improved patient experience.
Ethical considerations: this trial will assess the effects of using a VR patient journey preoperatively. Therefore, the trial will be highly systematic and at low risk of producing biased results. The trial will be adequately powered to limit the risk of random error. The participants receiving standard of care will likely not benefit directly from the trial. However, the participants in the control group will potentially assist with valuable evidence, which might benefit future patients. Participants can, at any time, for any reason, withdraw their consent to participate in the trial. If participants withdraw from the trial, it will not impact the level of care and treatment offered by the departments.
Informed consent: the trial will be conducted according to national and international standards of Good Clinical Practice. This trial protocol and amendments will be submitted to the Committee on Health Research Ethics in the Region Zealand of Denmark for approval before initiation of the trial. All patients scheduled for total knee arthroplasty will be screened for inclusion. The patients will be provided oral and written information about the trial, including potential benefits and risks, and invited to participate. The oral and written information will enable the patient to decide whether or not to participate in the trial. If the patients match all inclusion criteria and none of the exclusion criteria and decides to participate in the trial, both the patient and one of the trial personnel will have to sign the written informed consent paper.
The oral and written information can be provided by the Ph.D. student, a project nurse, or any employee from the project, collectively known as "trial personnel." The trial personnel can obtain consent. The trial personnel will be trained in all the procedures related to screening, informing potential participants, obtaining informed consent and inclusion of participants, randomization of participants, and how to handle the VR equipment.
Patients scheduled for elective surgery will be informed about the conduct of the trial at the anesthesia or orthopedic pre-consult, and written trial information will be provided.
All patients considered for inclusion will be informed about the mandatory verbal trial information consult. The patients will be informed of the possibility of bringing a next of kin to the mandatory verbal trial information consult. The verbal trial information consult will be held by other personnel trained to do so according to the Good Clinical Practice guidelines. The consult will take place in an explicit reserved room to prevent any disruptions. . The patient will be informed of the possibility of considering participation in the trial. The verbal trial information consult will be based on written information and contain information on the trial's purpose, potential risks and benefits, and the conduct of the trial. We will ensure that all patients, irrespective of being scheduled for surgery, will have at least 24 hours to consider their participation in the trial.
The patient will be informed that participation in the trial is voluntary and that consent can be withdrawn at any time without the decision to withdraw impacting further treatment. The patient will be asked if the investigators may continue to collect data relevant to the trial from the patient's medical records and if we are allowed to call them postoperatively to schedule an interview. Patients will be informed that randomization takes place on the day when the pre-anesthetic meeting is taking place. All stakeholders are bound by secrecy. The patient will receive trial information and the written informed consent declaration.
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, VR, Distraction, Non-pharmacological, Total Knee Arthroplasty, Orthopedic surgery, Orthopaedics, Spinal Anesthesia, Readiness
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
The subjects get a supplement of information via. a Vitual Reality (VR) headset. The information they get through the VR headset is about their course on the day of their surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients allocated to this group are getting the standard information from their anesthesiologist and a supplement of information via. a Virtual Reality (VR) headset. The information they get through the VR headset is about their course on the day of their surgery. Receives: Device: Virtual Reality |
| Control Group | No intervention | Patients allocated to this group are only getting standard information from their anesthesiologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative anxiety
Anxiety will be measured by using The Amsterdam Preoperative Anxiety and Information Scale (APAIS). The questionnaire contains six questions addressing topics: worries about the anesthetic, need for information about the anesthetic, worries about the procedure, and need for information about the procedure. Furthermore, the patients fill out the Numerical Rating Scale (NRS) according to anxiety rating from 0-10. 0 is no anxiety at alle, and 10 is the worst imaginable anxiety.
Measured: On the 1 day of inclusion and on the 1 day of the patient's surgery
Secondary outcomes (5)
Cumulative sedative consumption
Cumulative sedation is the total amount of sedatives administrated before and during surgery, and all sedative medications will be collected for comparison. Different opioids will be converted to morphine IV equivalents for comparison. The information will be collected from the digital patient journal (Sundhedsplatformen) by one of the research assistant.
Measured: On the 1 day of the patient's surgery
Opioid consumption
We will assess opioid consumption by conducting data from the digital patient journal (Sundhedsplatformen).
Measured: On the 1 day of the patient's surgery
Patient preoperatively expectations
The Treatment Expectation Questionnaire (TEX-Q) will assess patient expectation preoperatively. The questionnaire contains 15 questions and six supplemental questions dealing with; expected benefits, expected positive and negative impact, expected harm, desired benefits, desired impact, feared harm, feared negative impact, process-related expectations, and expected behavioral control of the treatment.
Measured: On the 1 day of inclusion
Patient preoperatively readiness
Readiness will be measured using the Preoperative Assessment of Readiness Tool (PART). The questionnaire contains 15 questions about readiness: understanding consent to the operation, time to ask questions, understanding the benefit of surgery, staff confirmation, enough time to decide, social security, spiritual preparation, and economic preparation.
Measured: On the 1 day of inclusion and on the 1 day of the patient's surgery
Adverse events
Adverse events are defined as any unwanted event, sign, or symptom occurring during the trial, whether the adverse is related to the VR head-mounted display or not. All adverse events will be noted in the Case Report Form. Adverse events are considered related to the trial from randomization until the end of the intervention period (48 hours postoperatively). The assumed adverse event's beginning, end, severity, and symptoms will be noted.
Measured: From the beginning of the intervention and until the end of the intervention period (48 hours postoperatively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start5 Mar 2024
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subjects are being randomized to one of two groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anja Geisler, phd, Study director, Region Hovedstadens Apotek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292663
- Sponsor's protocol ID
- EMN-2023-08767
- Status last verified
- Aug 2025
- First submitted
- 27 Feb 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
PubMed 24553908Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
PubMed 31278997Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
PubMed 28173795Rupp M, Lau E, Kurtz SM, Alt V. Projections of Primary TKA and THA in Germany From 2016 Through 2040. Clin Orthop Relat Res. 2020 Jul;478(7):1622-1633. doi: 10.1097/CORR.0000000000001214.
PubMed 32168057Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
PubMed 24187375Lu Y, Cregar WM, Goodloe JB, Khazi Z, Forsythe B, Gerlinger TL. General Anesthesia Leads to Increased Adverse Events Compared With Spinal Anesthesia in Patients Undergoing Unicompartmental Knee Arthroplasty. J Arthroplasty. 2020 Aug;35(8):2002-2008. doi: 10.1016/j.arth.2020.03.012. Epub 2020 Mar 12.
PubMed 32247674Hoxhallari E, Behr IJ, Bradshaw JS, Morkos MS, Haan PS, Schaefer MC, Clarkson JHW. Virtual Reality Improves the Patient Experience during Wide-Awake Local Anesthesia No Tourniquet Hand Surgery: A Single-Blind, Randomized, Prospective Study. Plast Reconstr Surg. 2019 Aug;144(2):408-414. doi: 10.1097/PRS.0000000000005831.
PubMed 31348351Torres GCS, Fernandez DF, Ledbetter L, Relf MV. Systematic Review of Preoperative Patient Readiness. AORN J. 2021 Jul;114(1):47-59. doi: 10.1002/aorn.13425.
PubMed 34181266Chang SL, Kuo MJ, Lin YJ, Chen SA, Chen CT, Yang YY, Yang LY, Kao SY, Shulruf B, Lee FY. Virtual reality-based preprocedural education increases preparedness and satisfaction of patients about the catheter ablation of atrial fibrillation. J Chin Med Assoc. 2021 Jul 1;84(7):690-697. doi: 10.1097/JCMA.0000000000000555.
PubMed 34029219Drazich BF, McPherson R, Gorman EF, Chan T, Teleb J, Galik E, Resnick B. In too deep? A systematic literature review of fully-immersive virtual reality and cybersickness among older adults. J Am Geriatr Soc. 2023 Dec;71(12):3906-3915. doi: 10.1111/jgs.18553. Epub 2023 Aug 10.
PubMed 37560978Tharion JG, Kale S. Patient Satisfaction Through an Immersive Experience Using a Mobile Phone-Based Head-Mounted Display During Arthroscopic Knee Surgery Under Spinal Anesthesia: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):940-948. doi: 10.1213/ANE.0000000000005666.
PubMed 34283040Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
PubMed 17352896Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.
PubMed 31005435Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
PubMed 32228525Zemla AJ, Nowicka-Sauer K, Jarmoszewicz K, Wera K, Batkiewicz S, Pietrzykowska M. Measures of preoperative anxiety. Anaesthesiol Intensive Ther. 2019;51(1):64-69. doi: 10.5603/AIT.2019.0013.
PubMed 31280554
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety? A Randomized Controlled Trial and Patient Interviews
- ClinicalTrials.gov ID
- NCT06292663
- Acronym / sponsor ID
- EMN-2023-08767
- Keywords
- Virtual Reality, VR, Distraction, Non-pharmacological, Total Knee Arthroplasty, Orthopedic surgery, Orthopaedics, Spinal Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 5 Mar 2024 (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.
The goal of this clinical trial is to test and learn about Virtual Reality (VR) providing preoperative information to patients undergoing elective TKA surgery in spinal anesthesia. The main question(s) aim(s) to answer if:
- Can preoperative information through a VR headset lower the patients preoperative anxiety?
- Can VR information make the patients more ready for surgery. Painscore will also be collected.
Participants will be randomized into two groups. One that will have preoperative information through VR versus standard information.
If there is a comparison group: Researchers will compare enrolled TKA patients to see if VR have an impact on anxiety, readiness and pain
Detailed description
Knee osteoarthritis (OA) causes pain, disability and poor quality of life in the elderly. Consequently, it can severely affect people's quality of life and physical function. International guidelines recommend exercise therapy alongside patient education and weight management (if needed) as first-line treatment for all individuals with knee OA. However, more than 1,000,000 TKA procedures are performed annually worldwide, and with aging populations and an increase in obesity, this number is expected to increase markedly4. Although TKA is generally considered an effective treatment option, up to 20% of patients are not fully satisfied after surgery5. Spinal anesthesia is commonly used during primary TKA given the purported safety benefits, quicker immediate postoperative recovery, decreased intraoperative bleeding, and lower transfusion rates when compared to general anesthesia. To help the patient feel more comfortable and relaxed during a procedure, administration of sedative medication titrated by the anesthetist is common practice. Despite a low rate of complications associated with spinal anesthesia compared to general anesthesia, it is important to acknowledge that complications can still occur.
Virtual Reality (VR) demonstrates signs as a promising tool to support healthcare, including mentally preparing the patient for a surgical procedure. Preoperative readiness, expectations, anxiety, and pain perception are crucial to the patient's surgical experiences. VR can immerse patients into a virtual environment and distract patients from e.g., unpleasant sounds, sights, and feelings. Integrating VR into preoperative care has shown the potential to offer several advantages, such as promoting patients' distraction, knowledge, and information. However, harms have been reported such as cyber sickness but only in few cases among older adult patients.
Offering a controlled environment where patients can familiarize themselves with the surgical process through VR shown on a head-mounted display (HMD) and with sound reduction headphones provides them an opportunity to explore, e.g., the operation theater, waiting area, and PACU.
All this can foster a sense of confidence and increased readiness and lead to an overall improved patient experience.
Ethical considerations: this trial will assess the effects of using a VR patient journey preoperatively. Therefore, the trial will be highly systematic and at low risk of producing biased results. The trial will be adequately powered to limit the risk of random error. The participants receiving standard of care will likely not benefit directly from the trial. However, the participants in the control group will potentially assist with valuable evidence, which might benefit future patients. Participants can, at any time, for any reason, withdraw their consent to participate in the trial. If participants withdraw from the trial, it will not impact the level of care and treatment offered by the departments.
Informed consent: the trial will be conducted according to national and international standards of Good Clinical Practice. This trial protocol and amendments will be submitted to the Committee on Health Research Ethics in the Region Zealand of Denmark for approval before initiation of the trial. All patients scheduled for total knee arthroplasty will be screened for inclusion. The patients will be provided oral and written information about the trial, including potential benefits and risks, and invited to participate. The oral and written information will enable the patient to decide whether or not to participate in the trial. If the patients match all inclusion criteria and none of the exclusion criteria and decides to participate in the trial, both the patient and one of the trial personnel will have to sign the written informed consent paper.
The oral and written information can be provided by the Ph.D. student, a project nurse, or any employee from the project, collectively known as "trial personnel." The trial personnel can obtain consent. The trial personnel will be trained in all the procedures related to screening, informing potential participants, obtaining informed consent and inclusion of participants, randomization of participants, and how to handle the VR equipment.
Patients scheduled for elective surgery will be informed about the conduct of the trial at the anesthesia or orthopedic pre-consult, and written trial information will be provided.
All patients considered for inclusion will be informed about the mandatory verbal trial information consult. The patients will be informed of the possibility of bringing a next of kin to the mandatory verbal trial information consult. The verbal trial information consult will be held by other personnel trained to do so according to the Good Clinical Practice guidelines. The consult will take place in an explicit reserved room to prevent any disruptions. . The patient will be informed of the possibility of considering participation in the trial. The verbal trial information consult will be based on written information and contain information on the trial's purpose, potential risks and benefits, and the conduct of the trial. We will ensure that all patients, irrespective of being scheduled for surgery, will have at least 24 hours to consider their participation in the trial.
The patient will be informed that participation in the trial is voluntary and that consent can be withdrawn at any time without the decision to withdraw impacting further treatment. The patient will be asked if the investigators may continue to collect data relevant to the trial from the patient's medical records and if we are allowed to call them postoperatively to schedule an interview. Patients will be informed that randomization takes place on the day when the pre-anesthetic meeting is taking place. All stakeholders are bound by secrecy. The patient will receive trial information and the written informed consent declaration.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The subjects are being randomized to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Virtual RealityPatients allocated to this group are getting the standard information from their anesthesiologist and a supplement of information via. a Virtual Reality (VR) headset. The information they get through the VR headset is about their course on the day of their surgery. |
| Control Group | No intervention | –Patients allocated to this group are only getting standard information from their anesthesiologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for total knee arthroplasty
- Scheduled for spinal anesthesia
- Age of 18 or above
- Ability to understand the trial protocol, risks, and benefits and provide signed informed consent
Key exclusion criteria (5 listed)
- Inability to read and understand Danish
- Uncooperativeness (as judged by investigators)
- Claustrophobia or fear of small spaces
- Disorders that prevent the person from wearing a VR device
- Highly visually or auditive impaired
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 RealityThe subjects get a supplement of information via. a Vitual Reality (VR) headset. The information they get through the VR headset is about their course on the day of their surgery. | Device | Intervention |
Primary outcome
Preoperative anxiety
Time frame: On the 1 day of inclusion and on the 1 day of the patient's surgery
Anxiety will be measured by using The Amsterdam Preoperative Anxiety and Information Scale (APAIS). The questionnaire contains six questions addressing topics: worries about the anesthetic, need for information about the anesthetic, worries about the procedure, and need for information about the procedure. Furthermore, the patients fill out the Numerical Rating Scale (NRS) according to anxiety rating from 0-10. 0 is no anxiety at alle, and 10 is the worst imaginable anxiety.
5 secondary outcomes
Cumulative sedative consumption
Time frame: On the 1 day of the patient's surgery
Opioid consumption
Time frame: On the 1 day of the patient's surgery
Patient preoperatively expectations
Time frame: On the 1 day of inclusion
Patient preoperatively readiness
Time frame: On the 1 day of inclusion and on the 1 day of the patient's surgery
Adverse events
Time frame: From the beginning of the intervention and until the end of the intervention period (48 hours postoperatively).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 24553908Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
- Background: PubMed 31278997Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.
- Background: PubMed 28173795Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:D): evidence-based education and supervised neuromuscular exercise delivered by certified physiotherapists nationwide. BMC Musculoskelet Disord. 2017 Feb 7;18(1):72. doi: 10.1186/s12891-017-1439-y.
- Background: PubMed 32168057Rupp M, Lau E, Kurtz SM, Alt V. Projections of Primary TKA and THA in Germany From 2016 Through 2040. Clin Orthop Relat Res. 2020 Jul;478(7):1622-1633. doi: 10.1097/CORR.0000000000001214.
- Background: PubMed 24187375Dunbar MJ, Richardson G, Robertsson O. I can't get no satisfaction after my total knee replacement: rhymes and reasons. Bone Joint J. 2013 Nov;95-B(11 Suppl A):148-52. doi: 10.1302/0301-620X.95B11.32767.
- Background: PubMed 32247674Lu Y, Cregar WM, Goodloe JB, Khazi Z, Forsythe B, Gerlinger TL. General Anesthesia Leads to Increased Adverse Events Compared With Spinal Anesthesia in Patients Undergoing Unicompartmental Knee Arthroplasty. J Arthroplasty. 2020 Aug;35(8):2002-2008. doi: 10.1016/j.arth.2020.03.012. Epub 2020 Mar 12.
- Background: PubMed 31348351Hoxhallari E, Behr IJ, Bradshaw JS, Morkos MS, Haan PS, Schaefer MC, Clarkson JHW. Virtual Reality Improves the Patient Experience during Wide-Awake Local Anesthesia No Tourniquet Hand Surgery: A Single-Blind, Randomized, Prospective Study. Plast Reconstr Surg. 2019 Aug;144(2):408-414. doi: 10.1097/PRS.0000000000005831.
- Background: PubMed 34181266Torres GCS, Fernandez DF, Ledbetter L, Relf MV. Systematic Review of Preoperative Patient Readiness. AORN J. 2021 Jul;114(1):47-59. doi: 10.1002/aorn.13425.
- Background: PubMed 34029219Chang SL, Kuo MJ, Lin YJ, Chen SA, Chen CT, Yang YY, Yang LY, Kao SY, Shulruf B, Lee FY. Virtual reality-based preprocedural education increases preparedness and satisfaction of patients about the catheter ablation of atrial fibrillation. J Chin Med Assoc. 2021 Jul 1;84(7):690-697. doi: 10.1097/JCMA.0000000000000555.
- Background: PubMed 37560978Drazich BF, McPherson R, Gorman EF, Chan T, Teleb J, Galik E, Resnick B. In too deep? A systematic literature review of fully-immersive virtual reality and cybersickness among older adults. J Am Geriatr Soc. 2023 Dec;71(12):3906-3915. doi: 10.1111/jgs.18553. Epub 2023 Aug 10.
- Background: PubMed 34283040Tharion JG, Kale S. Patient Satisfaction Through an Immersive Experience Using a Mobile Phone-Based Head-Mounted Display During Arthroscopic Knee Surgery Under Spinal Anesthesia: A Randomized Clinical Trial. Anesth Analg. 2021 Oct 1;133(4):940-948. doi: 10.1213/ANE.0000000000005666.
- Background: PubMed 17352896Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.
- Individual participant dataSharing planned: No
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Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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. This study is not recruiting at the moment.
Anja Geisler, phd study director
Region Hovedstadens Apotek
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 in people with Anxiety and Surgery, run by Zealand University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative anxiety (time frame: On the 1 day of inclusion and on the 1 day of the patient's surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06292663, which also lists 52 linked publications.
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 14 Aug 2025.