Virtual Reality on Anxiety Management During Elective Surgery

NCT06877663 | Completed

• 1 other identifier: Virtual Reality
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Discomfort; Pain Intensity Assessment

Keywords

Anxiety; Virtual Reality; Preoperative management; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• STAI score

  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 Outcomes (1)

• VAS scale

  It will be evaluated at 12-24-48 hours after surgery

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

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

Device: Virtual Reality Device

Control Group

NO INTERVENTION

Group B: Patients who will receive standard preoperative care and will serve as the control group.

Interventions

Virtual Reality Device DEVICE

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

Virtual Reality Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Caserta, CE, 81100, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and Outcome Assessor were all blinded to treatment allocation. Because the blinding of the operating surgeons was not feasible, they were not involved in the data collection and outcome assessment. Physicians in charge of patients' management were not involved in the operating room and were blinded to the device use. The data were collected and analyzed by physicians who were not involved in the patient's management during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, PhD

Model Details: This is a prospective, low-interventional randomized study on consecutive patients candidates for elective surgery. To investigate the effect of preoperative Virtual Reality (VR) entertainment on patient anxiety, patients will be randomized into two groups: * Group A: Patients who will receive entertainment videos via VR headset in the preoperative room before surgery. * Group B: Patients who will receive standard preoperative care and will serve as the control group.

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 14, 2025
• Study Start: May 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

IT (1)