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Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia

NCT05183412 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-09-27

No results posted yet for this study

Summary

By means of an investigator-initiated, monocentric, single-blinded, prospective, randomized controlled superiority trial, the effect of virtual reality (VR) therapy on patients undergoing ambulatory hand surgery under ultrasound-guided regional nerve block will be investigated. It is hypothesized that the usage of VR during the placement of the nerve block in ambulatory hand surgery patients provides a significant decrease in pain score during anesthesia compared to without VR glasses. Additionally, an objective stress related parameter (HRV), anxiety, VR experience (immersion and presence), adverse effects and patient satisfaction are evaluated before anesthesia, during anesthesia and surgery or after surgery through validated questionnaires or measurements.

Conditions

  • Anesthesia, Local
  • Surgery
  • Hand Injuries

Interventions

DEVICE

The Sedakit Oncomfort VR glasses (30-minutes Aqua program)

During placement of ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery, patients are subjected to a 30-minutes VR program (Oncomfort SA, Wavre, Belgium) 'Aqua' via a head-mounted display and headphone. The patients watch a VR underwater view of the ocean while listening to speeches to induce relaxation and meditation.

PROCEDURE

Ultrasound-guided regional nerve block and hand surgery without VR glasses

During placement of ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery, patients are NOT subjected to a 30-minutes VR program (Oncomfort SA, Wavre, Belgium) 'Aqua' via a head-mounted display and headphone.

PROCEDURE

Ultrasound-guided regional nerve block and hand surgery with VR glasses

Ultrasound-guided regional nerve block and hand surgery with VR glasses

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2023-09-06
Completion
2023-09-06

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05183412 on ClinicalTrials.gov