Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia
Condition: Anesthesia, Local; Surgery; Hand Injuries
MeSH terms: Hand Injuries
Study type: Interventional

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.
    

Intervention name(s): 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
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): 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.; 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
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Virtual reality glasses; Heart rate variability