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

August 18, 2025 updated by: khulud "Mohammad Hasham" Hasham Mansor, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Title: Effect of Virtual Reality on Intraoperative Anxiety, Stress, and Patient Satisfaction among Palestinian Patients Undergoing Regional Anesthesia

Background: Preoperative and intraoperative anxiety and stress are common psychological responses that negatively impact surgical outcomes and patient satisfaction. While pharmacological interventions are traditionally used to manage these responses, non-pharmacological methods such as virtual reality (VR) are gaining prominence. This study aimed to evaluate the effect of VR on intraoperative anxiety, stress, and patient satisfaction among Palestinian patients undergoing regional anesthesia.

Methods: A randomized controlled trial was conducted at Rafidia Governmental Surgical Hospital in Nablus, Palestine, from June to September 2024. A total of 150 patients scheduled for elective urological surgery under regional anesthesia were randomly assigned into VR (n=75) and control (n=75) groups. Participants in the VR group received immersive VR intervention during the operation using head-mounted devices, while the control group received routine care. Anxiety was assessed using the State-Trait Anxiety Inventory (STAI), stress using the Perceived Stress Scale (PSS-10), and patient satisfaction using the Visual Analog Scale (VAS). Hemodynamic parameters were also monitored.

Study Type

Interventional

Enrollment (Actual)

150

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

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:

  • 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

Exclusion Criteria:

  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group
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
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.
No Intervention: control group
Participants in the control group only receive standard care according to the hospital's protocol during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The State-Trait Anxiety Inventory (STAI)
Time Frame: preoperative and then 60 minutes postoperatively
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)
Time Frame: preoperative and 60 minutes postoperatively
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

Collaborators and Investigators

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

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

July 17, 2024

Primary Completion (Actual)

September 12, 2024

Study Completion (Actual)

October 12, 2024

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

August 18, 2025

First Posted (Actual)

August 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 18, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB RHDIRB2019041701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This research was conducted to achieve a PhD degree.The paper is currently under review for publication, and sharing it before the review process is complete could violate journal policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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