Effect of Virtual Reality on Anxiety, Stress, and Patient's Satisfaction Among Patients Undergoing Regional Anesthesia

NCT07132216 | Completed DMC

• 1 other identifier: IRB RHDIRB2019041701
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial was to investigate the effect of Virtual Reality (VR) on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia. The study aimed to determine the efficacy and safety of VR as a non-pharmacological intervention during surgery. The main research hypotheses are: H0: There will be no significant difference in anxiety levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy. H0: There will be no significant difference in perceived stress levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy. H0: There will be no significant difference in satisfaction levels between patients who receive immersive VR during regional anesthesia and those who do not receive pre- and post-virtual reality therapy. Participants will: Receive either VR intervention or standard care during their surgery. Complete assessments of anxiety and stress before and after the procedure using validated scales. Provide feedback on their satisfaction levels post-operation using a Visual Analog Scale. Be monitored for hemodynamic parameters throughout the surgical process.

Conditions

Perioperative Anxiety; Perioperative Stress; Patient Satisfaction; Regional Anesthesia; Elective Surgery

Outcome Measures

Primary Outcomes (2)

• The State-Trait Anxiety Inventory (STAI)

  The STAI score ranges between 20-80, the higher score indicating greater anxiety. It is classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).

  preoperative and then 60 minutes postoperatively

• Perceived Stress Scale (PSS-10)

  The PSS-10 score can range from 0 to 40 with higher scores indicating higher perceived stress. It is classified as "no or low anxiety" (0-13), "moderate anxiety" (14-26), and "high anxiety" (27-40).

  preoperative and 60 minutes postoperatively

Study Arms (2)

VR group

EXPERIMENTAL

The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.

Device: Meta Quest 2 VR headset

control group

NO INTERVENTION

Participants in the control group only receive standard care according to the hospital's protocol during the operation.

Interventions

Meta Quest 2 VR headset DEVICE

The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas (https://guidedmeditationvr.com/)featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia and before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.

VR 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:

• Patients who underwent elective urological surgery under regional anesthesia
• Patients older than 18 years
• Patients with no history of previous surgeries
• Patients suffering from moderate to severe anxiety and stress

You may not qualify if:

• Patients with a history of psychiatric disorders, epilepsy, hypertension, or chronic pain
• Patients who are mute and cannot read or write; patients with visual, hearing, or cognitive impairment
• Patients with implanted hearing aids or cardiac pacemakers
• Patients who received any anxiolytic, sedative, or hypnotic drugs before or during regional anesthesia
• Patients exposed to anesthetic or surgical complications during the operation

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Rafidia Surgical Governmental Hospital, Nablus City, West Bank, Palestine

Nablus, Palestinian Territories

Location

Related Publications (1)

• Mansor K, Abdellatif SA, Mohamed NA. Virtual reality for reducing intraoperative anxiety and improving patient satisfaction under regional anesthesia among palestinian patients: a randomized controlled trial. BMC Anesthesiol. 2025 Nov 27;25(1):593. doi: 10.1186/s12871-025-03475-3.

  PMID: 41310456 DERIVED

Related Links

• the website Guided Meditation VR application, developed by Cubicle Ninjas Agency

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients were not blinded due to the VR intervention, but the anesthesiologist and outcome assessors were blinded to group assignments. To maintain blinding for the anesthesiologist, VR headsets were covered with opaque drapes during clinical assessments, and research staff members not involved in clinical care managed the VR equipment. The anesthesiologist was only informed of group allocation after completing all clinical assessments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. The Meta Quest 2 VR headset with built-in headphones was used. Patients selected VR environments from a predefined list of five nature scenes (beach, forest, mountain, underwater, and meadow) with identical meditation audio tracks lasting 30 minutes each. Guided Meditation VR from Cubicle Ninjas featured 360-degree nature environments with standardized calming background music and guided meditation narration. VR was applied immediately after spinal anesthesia before the surgical incision. Sessions lasted 30 minutes and were discontinued if the patient reported nausea, dizziness, or requested removal.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 20, 2025
• Study Start: July 17, 2024
• Primary Completion: September 12, 2024
• Study Completion: October 12, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)