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

NCT06292663 | Completed

• 1 other identifier: EMN-2023-08767
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Anxiety; Surgery; Pain

Keywords

Virtual Reality; VR; Distraction; Non-pharmacological; Total Knee Arthroplasty; Orthopedic surgery; Orthopaedics; Spinal Anesthesia; Readiness

Outcome Measures

Primary Outcomes (1)

• 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.

  On the 1 day of inclusion and on the 1 day of the patient's surgery

Secondary Outcomes (5)

• Cumulative sedative consumption

  On the 1 day of the patient's surgery

• Opioid consumption

  On the 1 day of the patient's surgery

• Patient preoperatively expectations

  On the 1 day of inclusion

• Patient preoperatively readiness

  On the 1 day of inclusion and on the 1 day of the patient's surgery

• Adverse events

  From the beginning of the intervention and until the end of the intervention period (48 hours postoperatively).

Other Outcomes (2)

• Level of 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

  On the 1 day of inclusion and on the 1 day of the patient's surgery

Study Arms (2)

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.

Device: Virtual Reality

Control Group

NO INTERVENTION

Patients allocated to this group are only getting standard information from their anesthesiologist.

Interventions

Virtual Reality DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital

Køge, Region Sjælland, 4600, Denmark

Location

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MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anja Geisler, phd

  Region Hovedstadens Apotek

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The primary investigator will stay blinded in this study and an assistant to the investigator is screening and including the patients and collecting data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The subjects are being randomized to one of two groups.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: March 5, 2024
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)