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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
233

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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