Anesthesia, LocalNCT05183412
Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia
A study testing The Sedakit Oncomfort VR glasses (30-minutes Aqua program), Ultrasound-guided regional nerve block and hand surgery without VR glasses and Ultrasound-guided regional nerve block and hand surgery with VR glasses in people with Anesthesia, Local and Surgery, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Local, Surgery, Hand Injuries
- What is being tested?
- The Sedakit Oncomfort VR glasses (30-minutes Aqua program), Ultrasound-guided regional nerve block and hand surgery without VR glasses and Ultrasound-guided regional nerve block and hand surgery with VR glasses
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jan 2022to 6 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia: a Randomized Controlled Superiority Trial.
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.
Read the 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
- Being tested
- The Sedakit Oncomfort VR glasses (30-minutes Aqua program), Ultrasound-guided regional nerve block and hand surgery without VR glasses, Ultrasound-guided regional nerve block and hand surgery with VR glasses
- Keywords
- Virtual reality glasses, Heart rate variability
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 without VR glassesProcedure or surgery
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 glassesProcedure or surgery
Ultrasound-guided regional nerve block and hand surgery with VR glasses
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: The Sedakit Oncomfort VR glasses (30-minutes Aqua program); Procedure: Ultrasound-guided regional nerve block and hand surgery with VR glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Procedure (At the end of performing the ultrasound-guided regional anesthesia block)
Secondary outcomes (11)
Pain due to the surgery: Numeric Rating Scale (NRS)
Pain caused by performing the hand surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
Measured: Intraoperative (At the end of surgery)
Stress: Heart rate variability (HRV)
Heart rate variability (HRV), is the fluctuation of the length between consecutive heart beats in milliseconds and is regulated by the autonomic nerve system. It determines the balance between the parasympathetic 'rest and digest' and sympathetic 'flight or fight' nerve systems. The sympathetic branch decreases HRV during stressful situations, while the parasympathetic branch increases HRV at rest. This natural interplay between the two systems allows the heart to quickly respond to different stimuli, including stress. HRV (being RMSSD and HF-HRV), is measured during placement of an ultrasound-guided regional anesthesia block and surgery through the Empatica E4 wristband (Photoplethysmography).
Measured: 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)
Anxiety caused by performing the anesthesia technique (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
Measured: 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)
Anxiety caused by performing the hand surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)
Measured: Intraoperative (At the end of surgery)
Pre-surgical anxiety (Surgical Fear Questionnaire)
Pre-surgical anxiety for the anesthesia and surgery (measured with the Surgical Fear Questionnaire)
Measured: Arrival at the 1 day clinic
VR experience: Immersion and presence (Igroup questionnaire)
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.
Measured: Intraoperative (At the end of surgery)
Adverse effects (Simulation Sickness Questionnaire and Virtual Reality Symptom Questionnaire)
Adverse effects (dizziness, headache, motion sickness, postoperative nausea and vomiting, fatigue, claustrophobia) are evaluated by the virtual reality symptom questionnaire (VRSQ) and Simulator sickness questionnaire (SSQ).
Measured: Intraoperative (At the end of surgery)
Opiod use peroperatively
Rescue medication in case of block failure.
Measured: Intraoperative (At the end of surgery)
Patient satisfaction (7-point Likert scale)
Patient satisfaction measured with the Patient Satisfaction Questionnaire and a 7-point Likert scale for measuring satisfaction rates with anesthesia, surgery and VR experience.
Measured: Intraoperative (At the end of surgery)
Needling time
The time from injection of the needle to the removal of the needle.
Measured: Procedure (During performing the ultrasound-guided regional anesthesia block)
Surgical time
The time from incision to surgical completion
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start26 Jan 2022
- Primary completion6 Sep 2023
- Study completion6 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183412
- Sponsor's protocol ID
- f/2021/126
- Status last verified
- Sep 2024
- First submitted
- 5 Jan 2022
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40451290
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia: a Randomized Controlled Superiority Trial.
- ClinicalTrials.gov ID
- NCT05183412
- Acronym / sponsor ID
- f/2021/126
- Conditions
- Anesthesia, Local, Surgery, Hand Injuries
- Keywords
- Virtual reality glasses, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 6 Sep 2023 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided regional nerve block and hand surgery without VR glasses | Active comparator | Procedure: Ultrasound-guided regional nerve block and hand surgery without VR glassesPatients will not receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery. |
| Ultrasound-guided regional nerve block and hand surgery with VR glasses | Experimental | Device: The Sedakit Oncomfort VR glasses (30-minutes Aqua program), Procedure: Ultrasound-guided regional nerve block and hand surgery with VR glassesPatients will receive the VR glasses during the ultrasound-guided regional nerve block (axillary or distal peripheral) and hand surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Ultrasound-guided regional nerve block and hand surgery with VR glasses |
| Ultrasound-guided regional nerve block and hand surgery without VR glassesDuring 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 or surgery | Ultrasound-guided regional nerve block and hand surgery without VR glasses |
| Ultrasound-guided regional nerve block and hand surgery with VR glassesUltrasound-guided regional nerve block and hand surgery with VR glasses | Procedure or surgery | Ultrasound-guided regional nerve block and hand surgery with VR glasses |
Primary outcome
Pain due to the placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS)
Time frame: Procedure (At the end of performing the ultrasound-guided regional anesthesia block)
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)
11 secondary outcomes
Pain due to the surgery: Numeric Rating Scale (NRS)
Time frame: Intraoperative (At the end of surgery)
Stress: Heart rate variability (HRV)
Time frame: 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)
Time frame: 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)
Time frame: Intraoperative (At the end of surgery)
Pre-surgical anxiety (Surgical Fear Questionnaire)
Time frame: Arrival at the 1 day clinic
VR experience: Immersion and presence (Igroup questionnaire)
Time frame: Intraoperative (At the end of surgery)
Adverse effects (Simulation Sickness Questionnaire and Virtual Reality Symptom Questionnaire)
Time frame: Intraoperative (At the end of surgery)
Opiod use peroperatively
Time frame: Intraoperative (At the end of surgery)
Patient satisfaction (7-point Likert scale)
Time frame: Intraoperative (At the end of surgery)
Needling time
Time frame: Procedure (During performing the ultrasound-guided regional anesthesia block)
Surgical time
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Derived from this study: PubMed 40451290Nijs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Sedakit Oncomfort VR glasses (30-minutes Aqua program), Ultrasound-guided regional nerve block and hand surgery without VR glasses and Ultrasound-guided regional nerve block and hand surgery with VR glasses in people with Anesthesia, Local and Surgery, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain due to the placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS) (time frame: Procedure (At the end of performing the ultrasound-guided regional anesthesia block)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.