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

Not Applicable

Completed

• Conditions: Perioperative Anxiety; Perioperative Stress; Patient Satisfaction; Regional Anesthesia; Elective Surgery

• Registration Number: NCT07132216
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study Start: 2024-07-17
• Primary Completion: 2024-09-12
• Study Completion: 2024-10-12
• Status Verified: 2025-08
• Study First Submitted: 2025-08-12
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The State-Trait Anxiety Inventory (STAI)	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).
Perceived Stress Scale (PSS-10)	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).

Trial Locations

Locations (1)

Rafidia Surgical Governmental Hospital, Nablus City, West Bank, Palestine; 🇵🇸 Nablus, Palestinian Territory, occupied