Virtual Reality on Anxiety Management During Elective Surgery

September 17, 2025 updated by: Claudio Gambardella, University of Campania Luigi Vanvitelli

Impact of Virtual Reality on Anxiety Management During Elective Surgery

The aim of this research is to assess and compare the effects of audiovisual content administered via specific Meta Quest 2 headsets on pre-surgical anxiety in patients undergoing elective surgical procedures and on procedure-related comfort.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preoperative anxiety is a very common condition in all individuals undergoing surgical procedures. On the day of the procedure, in fact, between 50% and 70% of patients experience anxiety, which usually peaks during anesthesia induction. The main concerns underlying pre-surgical anxiety include fear of surgical complications, worries about the duration of the procedure, the potential onset of subsequent disabilities, as well as concerns regarding general anesthesia and the associated loss of control. Additionally, a common fear is waking up and experiencing discomfort and pain during the procedure. More anxious patients are at greater risk of problems during anesthesia induction, difficulties in pain management, and a more challenging recovery. These frequent conditions highlight the need for interventions aimed at reducing preoperative anxiety.

Currently, the most common prevention/treatment for preoperative anxiety is a pharmacological approach. The pharmacological option includes sedatives and anxiolytic drugs, which, however, may cause adverse effects such as respiratory problems, drowsiness, interactions with anesthetic drugs, and prolonged recovery time. Therefore, non-pharmacological interventions are becoming increasingly common.

There are also other non-pharmacological approaches, although less widespread, including cognitive-behavioral therapy (the current gold-standard treatment for anxiety disorders), aromatherapy, and music therapy. Additionally, in pediatric surgery, audiovisual support has been tested as a means of reducing anxiety levels, particularly when focused on providing preoperative management information, administered 48 hours before the scheduled surgery. This practice has also been found to be more satisfactory than traditional play activities with toys.

Currently, several all-in-one virtual reality (VR) headsets are available on the market, capable of immersing an individual in an artificially constructed reality. Specifically, the Meta Quest 2 ™ headset (Meta®, Menlo Park, California, USA) explores VR on a standalone platform, with advanced privacy features to encrypt data and parental supervision tools to ensure appropriate content for all users. In the medical field, VR headsets have already been tested in rehabilitation, ophthalmology, and surgery as a therapeutic method for patients, as well as a fundamental tool for physician training.

The objective of this study is to evaluate the impact of VR on patients undergoing elective surgery in reducing preoperative anxiety and improving patient comfort.

Study Type

Interventional

Enrollment (Actual)

233

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

  • Italy
    • CE
      • Caserta, CE, Italy, 81100
        • University of Campania Luigi Vanvitelli

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:

  • Age >18 years
  • Age <70 years
  • Indication for elective surgery

Exclusion Criteria:

  • Diagnosis of Anxiety Disorder, Major Depression, Personality Disorder, Bipolar Syndrome
  • Substance abuse
  • Inability to complete the study protocol
  • Patients for whom the surgical procedure was not performed

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Group
Group A: Patients who will receive entertainment videos via VR headset in the preoperative room before surgery.
Device: Virtual Reality Device
Patients who will receive entertainment videos via VR headset in the preoperative room before surgery.
No Intervention: Control Group
Group B: Patients who will receive standard preoperative care and will serve as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STAI score
Time Frame: It will be administered at three different time points for both the control group (Group B) and the experimental Group A (screening, before surgery, and 48 hours after the operation) to quantify patient anxiety levels.
Assessment of the difference in State-Trait Anxiety Inventory (STAI; range 20-80; a higher score indicates a higher level of anxiety) score between the two groups at baseline, preoperatively, and postoperatively
It will be administered at three different time points for both the control group (Group B) and the experimental Group A (screening, before surgery, and 48 hours after the operation) to quantify patient anxiety levels.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS scale
Time Frame: It will be evaluated at 12-24-48 hours after surgery
Perioperative pain will be evaluated using the Visual Analog Scale (VAS; range 0-10; a higher score indicates greater pain).
It will be evaluated at 12-24-48 hours after surgery

Collaborators and Investigators

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

Sponsor

University of Campania Luigi Vanvitelli

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)

May 1, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 14, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtual Reality

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We have to discuss it with the central Institution

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.

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