Clinical trial NCT04869553: Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care
Official title: Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Keywords: Pain management
Hypnosis
Virtual Reality
Distractibility methods
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Controlled, randomised, open-label, cross-over, 3-sequence study (uniform design across time and sequence: ABC/BCA/CAB).

* Treatment A: Usual pain management of each ward
* Treatment B: Usual pain management on each ward and analgesic hypnotherapy during care
* Treatment C: Usual pain management of each ward and virtual reality session using a suitable headset.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesia Nociception Index (ANI) during painful care interventions
timeFrame: one month
Secondary outcomes:
measure: ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods
timeFrame: one month
measure: Visual Analog Scale (VAS)
timeFrame: one month
measure: Morphine equivalent
timeFrame: one month
measure: Proportion of patients tolerance to distractibility techniques
timeFrame: one month
measure: Correlation between patient age and tolerance
timeFrame: one month
measure: Correlation between patient age and treatment efficacy
timeFrame: one months
measure: Correlation between caregiver training level and hypnosis efficacy
timeFrame: one month
measure: Percentage of satisfaction concerning the distractibility techniques.
timeFrame: one month
measure: IPQ (Igroup Presence Questionnaire) scale
timeFrame: one month
Other outcomes:
Locations:
city: Hyères
country: France
facility: Hôpital Léon Bérard
city: Lyon
country: France
facility: Centre médico-chirurgical des Massues
city: Perpignan
country: France
facility: USSAP - Centre Bouffard Vercelli
city: Ploemeur
country: France
facility: Centre Mutualiste de Kerpape
city: Rennes
country: France
facility: Pôle MPR Saint Hélier
city: Roscoff
country: France
facility: Fondation ILDYS - Site de Perharidy
city: Saint-Fargeau-Ponthierry
country: France
facility: Fondation Ellen Poidatz - Centre de Rééducation Fonctionnelle
city: Villeneuve-d'Ascq
country: France
facility: SSR Pédiatrique Marc Sautelet
Study officials:
affiliation: Hôpital Léon Bérard
name: Marie-Noëlle BARTHOLOMEI, PharmD
role: STUDY_DIRECTOR
References: