Clinical trial NCT05183412: Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia
Official title: Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia: a Randomized Controlled Superiority Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Surgery
Hand Injuries
Keywords: Virtual reality glasses
Heart rate variability
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain due to the placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS)
timeFrame: Procedure (At the end of performing the ultrasound-guided regional anesthesia block)
Secondary outcomes:
measure: Pain due to the surgery: Numeric Rating Scale (NRS)
timeFrame: Intraoperative (At the end of surgery)
measure: Stress: Heart rate variability (HRV)
timeFrame: 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.
measure: Anxiety due to placement of the ultrasound-guided regional anesthesia block: Numeric Rating Scale (NRS)
timeFrame: Procedure (At the end of performing the ultrasound-guided regional anesthesia block)
measure: Anxiety due to the surgery: Numeric Rating Scale (NRS): Numeric Rating Scale (NRS)
timeFrame: Intraoperative (At the end of surgery)
measure: Pre-surgical anxiety (Surgical Fear Questionnaire)
timeFrame: Arrival at the 1 day clinic
measure: VR experience: Immersion and presence (Igroup questionnaire)
timeFrame: Intraoperative (At the end of surgery)
measure: Adverse effects (Simulation Sickness Questionnaire and Virtual Reality Symptom Questionnaire)
timeFrame: Intraoperative (At the end of surgery)
measure: Opiod use peroperatively
timeFrame: Intraoperative (At the end of surgery)
measure: Patient satisfaction (7-point Likert scale)
timeFrame: Intraoperative (At the end of surgery)
measure: Needling time
timeFrame: Procedure (During performing the ultrasound-guided regional anesthesia block)
measure: Surgical time
timeFrame: During surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa hospital
state: Limburg
Study officials:
References: