CHU Clermont-Ferrand
Clermont-Ferrand, France
NCT Number: NCT05364203
The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.
The secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Clermont-Ferrand, France
Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be painful and the tolerance of the injections varies from one patient to another. The pain felt during the injection causes in most patients great stress during the injection.
Virtual reality is a video technique with 360 ° vision simulating the physical presence of the patient in an "existing" environment outside the hospital setting. This technique has been used in painful procedures but only one publication, in pediatrics, has shown a decrease in pain and agitation during botulinum toxin injections.
The hypothesis of this research is that an immersive virtual reality system can, in adults, reduce stress and the painful experience of botulinum toxin injections.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
DEEPSEN virtual reality mask with 360 ° vision. The audio-visual content will be chosen by the patient.
Time frame: during the procedure
The stress measurement is carried out using a watch and a belt (heart rate monitor) which, thanks to several parameters, will allow us to carry out an HRV analysis on the KUBIOS software.
Time frame: during the procedure
At the end of the injections, the doctor asks the patient to give a score between 0 (no pain) and 10 (the worst pain), in order to give an idea of the pain felt during the botulinum toxin injections.
Time frame: during the procedure
Estimate by the doctor immediately after the end of the session [by a simple numerical scale (ENS) ranging from 0 ("extremely bad conditions") to 10 ("extremely good conditions")] or [on a 5-point Likert type scale points (conditions extremely bad/poor/neither bad nor good/good/extremely good)]
University Hospital, Clermont-Ferrand
Other
Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity
Acronym: RVTOX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06782464
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Luxembourg
View Trial DetailsNCT07303582
Acquired Brain Injury (Including Stroke), Autoimmune Diseases
Oxford, United Kingdom
View Trial DetailsNCT06117020
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
San Antonio, Texas, United States
View Trial DetailsNCT05156164
Brain Diseases, Cardiovascular Diseases
Roma, RM, Italy
View Trial Details