Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT05183412
Status:
COMPLETED
Last Update Posted:
2024-09-27
First Post:
2022-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia
Sponsor:
Jessa Hospital
Organization:
Study Overview
Official Title:
Effect of Virtual Reality (VR) Therapy on Patients Undergoing Hand Surgery Under Ultrasound-guided Regional Anesthesia: a Randomized Controlled Superiority Trial.
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: