Status:
COMPLETED
Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care
Lead Sponsor:
Lille Catholic University
Conditions:
Pain
Eligibility:
All Genders
15+ years
Phase:
NA
Brief Summary
The originality of this study is the comparison of different distractibility techniques (hypnosis and virtual reality) in the very heterogenous contexts of pain management. This study will consider al...
Detailed Description
Pain is defined as an unpleasant sensorial and emotional experience related to a potential or existing tissue injury (psychological (affective) and physical dimension of pain). Since it can occur at a...
Eligibility Criteria
Inclusion
- Patients undergoing care interventions of a given type (e.g. wound dressings/mobilization/…) recognized as painful (pain VAS \>3 despite the usual analgesic protocol)
- Repetition of the same type of intervention at least three times within a month of interval after inclusion
- Patient age ≥15 years
- Informed consent from patient or legal guardian
- Beneficiary of the French healthcare fund
Exclusion
- MEOPA's administration during painful treatment as part of the study
- Cognitive or psychiatric disorders preventing the patient from communicating with caregivers or understanding their instructions
- Any other concomitant nervous system, cardiac, or pulmonary disease that might affect the autonomous nervous system: (myocardial infarction, myocardial disorder (e.g. dilated or hypertrophic cardiomyopathy), class 3 or 4 heart failure, cardia dysrhythmia, including atrial fibrillation, conduction disorder, mechanical ventilation)
- Non-sinusal rhythm, extrasystoles, altered ECG signals related to heart disease
- Mandatory drug therapy that might affect the autonomous nervous system and NRV such as beta-blockers, muscarinic receptor blockers (mainly atropine, scopolamine), vasopressin agents
- Contraindication for use of the virtual reality headset and/or hypnosis. Neurological disorder incompatible with use of the virtual reality headset and/or hypnosis (balance disorders/seizures…)
- Contraindication for using surface electrodes preventing collection of the main endpoint data
- Any disorder or disability preventing execution of the virtual reality or hypnosis techniques (deafness/blindness)
- Judicial protection status
Key Trial Info
Start Date :
January 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04869553
Start Date
January 7 2022
End Date
May 24 2024
Last Update
September 10 2025
Active Locations (5)
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1
Hôpital Léon Bérard
Hyères, France, 83418
2
USSAP - Centre Bouffard Vercelli
Perpignan, France, 66962
3
Centre Mutualiste de Kerpape
Ploemeur, France, 56275
4
Pôle MPR Saint Hélier
Rennes, France, 35043