NCT05183412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

January 26, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2023

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

January 5, 2022

Last Update Submit

September 26, 2024

Conditions

Anesthesia, LocalSurgeryHand Injuries

Keywords

Virtual reality glassesHeart rate variability

Outcome Measures

Primary Outcomes (1)

  • Pain due to the placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS)

    Pain caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

    Procedure (At the end of performing the ultrasound-guided regional anesthesia block)

Secondary Outcomes (11)

  • Pain due to the surgery: Numeric Rating Scale (NRS)

    Intraoperative (At the end of surgery)

  • Stress: Heart rate variability (HRV)

    Before performing the ultrasound-guided regional anesthesia block for 5 minutes in rest (baseline), procedure (during performing the ultrasound-guided regional anesthesia block ) and minute 0 - 5 during the surgical procedure.

  • Anxiety due to placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS)

    Procedure (At the end of performing the ultrasound-guided regional anesthesia block)

  • Anxiety due to the surgery: Numeric Rating Scale (NRS): Numeric Rating Scale (NRS)

    Intraoperative (At the end of surgery)

  • Pre-surgical anxiety (Surgical Fear Questionnaire)

    Arrival at the 1 day clinic

  • +6 more secondary outcomes

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

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

EXPERIMENTAL

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

Device: The Sedakit Oncomfort VR glasses (30-minutes Aqua program)Procedure: Ultrasound-guided regional nerve block and hand surgery with VR glasses

Interventions

The Sedakit Oncomfort VR glasses (30-minutes Aqua program)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
Ultrasound-guided regional nerve block and hand surgery without VR glassesPROCEDURE

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

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

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa hospital

Hasselt, Limburg, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 40451290DERIVED

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Two independent assessors will gather data in this study: one blinded and one unblinded.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 10, 2022

Study Start

January 26, 2022

Primary Completion

September 6, 2023

Study Completion

September 6, 2023

Last Updated

September 27, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)