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OpenTrials
Completed

NCT Number: NCT06877663

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Campania Luigi Vanvitelli

Caserta, CE, 81100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Device

Device

Patients who will receive entertainment videos via VR headset in the preoperative room before surgery.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Official study title

Impact of Virtual Reality on Anxiety Management During Elective Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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