Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 10
- Primary Endpoint
- Analgesia Nociception Index (ANI) during painful care interventions
Study Overview
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 all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
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 any stage of care, pain concerns all healthcare teams working in acute care units or follow-up care centers.
At the present time, pain management is mainly based on the use of analgesic agents that calm or suppress pain. Different types of analgesic agents are available in the therapeutic armamentarium (non-opioid analgesics and opioid analgesics as morphine).
In this context where pain management is a priority and where the use of morphine is constantly on the rise exposing patients to significant risk (adverse effects, addictions, respiratory events….), the use of distractibility techniques as hypnosis and virtual reality could be an attractive alternative.
- Hypnosis designates both a therapeutic technique and a modified state of consciousness also called trance (a state where the person is between a state of wakefulness and sleep).
- Virtual reality designates a three-dimensional computer-controlled environment allowing immersion, interaction and multisensorial input.
Thus, the originality of this study is the comparison of different distractibility techniques in the very heterogenous contexts of pain management. This study will consider all types of care situations. The study's cross-over design will take into account this heterogenous context. The results will be representative of real-life situations where care for pain involves a wide range of contexts.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
ABC's arm
The 3 pain managements are in the ABC's order.
Intervention: Management pain with distraction methods ABC (Other)
BCA's arm
The 3 pain managements are in the BCA's order.
Intervention: Management pain with distraction methods BCA (Other)
CAB's arm
The 3 pain managements are in the CAB's order.
Intervention: Management pain with distraction methods CAB (Other)
Outcomes
Primary Outcomes
Analgesia Nociception Index (ANI) during painful care interventions
Time Frame: one month
This index is derived from heart rate variability and reflects the relative parasympathetic tone. An ANI value close to 100 corresponds to a prominent parasympathetic tone (low stress level, analgesia) and a value close to 0 corresponds to a prominent sympathetic tone (high stress level, nociception).
Secondary Outcomes
- ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods(one month)
- IPQ (Igroup Presence Questionnaire) scale(one month)
- Visual Analog Scale (VAS)(one month)
- Morphine equivalent(one month)
- Proportion of patients tolerance to distractibility techniques(one month)
- Correlation between patient age and tolerance(one month)
- Correlation between patient age and treatment efficacy(one months)
- Correlation between caregiver training level and hypnosis efficacy(one month)
- Percentage of satisfaction concerning the distractibility techniques.(one month)
- Correlation between patient age and treatment efficacy(one months)
- Visual Analog Scale (VAS)(one month)
- Morphine equivalent(one month)
- ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods(one month)
- Proportion of patients tolerance to distractibility techniques(one month)
- Correlation between patient age and tolerance(one month)
- Correlation between caregiver training level and hypnosis efficacy(one month)
- Percentage of satisfaction concerning the distractibility techniques.(one month)
- IPQ (Igroup Presence Questionnaire) scale(one month)