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

NCT ID: NCT05183412

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2023-09-06

Brief 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.

Detailed Description

Ultrasound-guided regional anesthesia (RA) is the golden standard in ambulatory superficial hand surgery due to its safety and reliability. Frequently used RA techniques are ultrasound-guided distal peripheral nerve block of the n. medianus and n. ulnaris is and ultrasound-guided axillary nerve block of the n. medianus, n. ulnaris, n. radialis, and n. musculocutaneous. The needling is frequently accompanied by stress, fear or anxiety and it has been proven in studies that psychological factors can affect the sensation of pain. At this moment systemic opioids and/or sedatives used, however, these partially neutralize the benefits of locoregional techniques.

Virtual reality (VR) is a non-pharmacologic and non-invasive simulation in which the user can interact within a 3D-computer-generated environment using special glasses with a screen and a headset. VR offers the ability to distract patients from reality and can therefore relieve a pain sensation from harmful stimuli. An important aspect of pain reduction in VR is presence and immersion. The physical/sensory stimulus offered by the artificial environment is referred to as immersion. Presence can be defined as one's sense of being in an artificial environment. The VR glasses of the firm Oncomfort called Sedakit™ have been proven to be safe and effective in previous clinical trials. A VR program namely 'Aqua', has been provided and designed for relaxation and distraction from anxiety or pain of patients.

Current literature is lacking objective parameters of stress within an operative, anesthesiologic framework. One of these objective stress-related parameters of is heart rate variability (HRV). HRV is the fluctuation of the length between consecutive heart beats and refers to the heart's ability to react to a wide range of physiological and environmental stimuli such as stress. HRV can be measured by the Empatica E4 wristband.

The proposed study, performed at the Jessa hospital, will assess the effect of VR glasses on pain levels of hand surgery patients during placement of the nerve block and surgery by comparing a group with VR glasses to without VR glasses. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Patients will not receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

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

Patients will receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• ≥18 years and <65 years
• ASA (American Society of Anesthesiology) classification: 1 - 3
• Patient scheduled for ambulatory hand surgery using ultrasound-guided axillary block regional anesthesia or ultrasound-guided peripheral nerve block.

Exclusion Criteria

• Bilateral surgery
• BMI ≥ 40 kg/m²
• Motion sickness
• Patient that take medication that affects heart rhythm (beta-blockade)
• Infection in the area for peripheral nerve block injections.
• Existing neurological conditions.
• Chronic pain symptoms
• Opioid use within the past 3 months
• Allergy to local anesthetics
• Inability to experience the VR glasses experience (Vision disorders)
• Inability to understand study design or mental impairment
• Patients with autonomic nervous system dysfunction
• Pregnancy
• Heart transplant patients, patients with diabetic neuropathy, patients with myocardial infarction (or having passed through it) and/or tetraplegic patients
• Fear of being under water
• Sea sickness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stessel Björn

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jessa hospital

Hasselt, Limburg, Belgium

Countries

Belgium

References

Nijs K, Treunen T, Jalil H, Lensen M, Wintmolders H, Keunen B, Vanloon M, Callebaut I, Geebelen L, Van de Velde M, Stessel B. Effect of virtual reality (VR) therapy on pain sensation in patients undergoing hand surgery under ultrasound-guided regional anesthesia: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 1:rapm-2025-106418. doi: 10.1136/rapm-2025-106418. Online ahead of print.

Reference Type: DERIVED

PMID: 40451290 (View on PubMed)

Other Identifiers

f/2021/126

Identifier Type: -

Identifier Source: org_study_id