Can Preoperative Information Via Virtual Reality Affect Patient's Anxiety?

August 13, 2025 updated by: Zealand University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Zealand
      • Køge, Zealand, Denmark, 4600
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
Device: Virtual Reality
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.
No Intervention: Control Group
Patients allocated to this group are only getting standard information from their anesthesiologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
On the 1 day of inclusion and on the 1 day of the patient's surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative sedative consumption
Time Frame: On the 1 day of the patient's surgery
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.
On the 1 day of the patient's surgery
Opioid consumption
Time Frame: On the 1 day of the patient's surgery
We will assess opioid consumption by conducting data from the digital patient journal (Sundhedsplatformen).
On the 1 day of the patient's surgery
Patient preoperatively expectations
Time Frame: On the 1 day of inclusion
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.
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
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.
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).
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.
From the beginning of the intervention and until the end of the intervention period (48 hours postoperatively).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of pain
Time Frame: On the 1 day of inclusion and the 1 day of the patient's surgery, at PACU and 24 hour postoperatively
Pain will be assessed at the day of inclusion, at the day of surgery, at the Post Anesthesia Care Unit (PACU), and 24hr after surgery (+/- 4hr). The research assistant will ask the patient to rate their pain on a scale from 0-10. 0 is no pain, and 10 is the worst imaginable pain.
On the 1 day of inclusion and the 1 day of the patient's surgery, at PACU and 24 hour postoperatively
The need for information
Time Frame: On the 1 day of inclusion and on the 1 day of the patient's surgery
The need for information among patients will be assesed by using the The Amsterdam Preoperative Anxiety and Information Scale (APAIS)
On the 1 day of inclusion and on the 1 day of the patient's surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Study Director: Anja Geisler, phd, Region Hovedstadens Apotek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Actual)

June 20, 2025

Study Completion (Actual)

June 20, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMN-2023-08767

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Virtual Reality

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe