Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care

Pain Clinical Trial

— PADIS  

Official title:

Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04869553
• Other study ID #: RC-P00102
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: February 7, 2025

Study information

• Verified date: March 2024
• Source: Lille Catholic University
• Contact: Marie Paule Lebitasy
• Phone: 03 20 22 52 69
• Email: Lebitasy.Marie-Paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 7, 2025
• Est. primary completion date: February 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Management pain with distraction methods ABC
Every patient will receive : The usual pain management of their ward (Treatment A), The usual pain management of their ward with a hypnosis session (Treatment B) The usual pain management of their ward with a virtual reality session (Treatment C)
• Management pain with distraction methods BCA
Every patient will receive : The usual pain management of their ward with a hypnosis session (Treatment B) The usual pain management of their ward with a virtual reality session (Treatment C) The usual pain management of their ward (Treatment A)
• Management pain with distraction methods CAB
Every patient will receive : The usual pain management of their ward with a virtual reality session (Treatment C) The usual pain management of their ward (Treatment A) The usual pain management of their ward with a hypnosis session (Treatment B)

Locations

Country	Name	City	State
France	Hôpital Léon Bérard	Hyères
France	Centre médico-chirurgical des Massues	Lyon
France	USSAP - Centre Bouffard Vercelli	Perpignan
France	Centre Mutualiste de Kerpape	Ploemeur
France	Pôle MPR Saint Hélier	Rennes
France	Fondation ILDYS - Site de Perharidy	Roscoff
France	Fondation Ellen Poidatz - Centre de Rééducation Fonctionnelle	Saint-Fargeau-Ponthierry
France	SSR Pédiatrique Marc Sautelet	Villeneuve-d'Ascq

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesia Nociception Index (ANI) during painful care interventions	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).	one month
Secondary	ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods	A comparison between the ANI's score before and after the care and the distractibility methods. The average of the scores will be retained.	one month
Secondary	Visual Analog Scale (VAS)	The pain's level will be evaluated by the Visual Analog Scale (VAS). This scale measure the pain's intensity from 0 to 10.	one month
Secondary	Morphine equivalent	The opioid analgesics administered during the care will be converted into morphine equivalent by means of the opioid equi-analgesia table. The collection of analgesics will include all analgesics "in action" on the day of care.	one month
Secondary	Proportion of patients tolerance to distractibility techniques	All events leading to a discontinuation of the distractibility technique will be recorded: side effects /cybersickness (nausea, vertigo evaluated using the Speech, Spatial and Qualities (SSQ) of Hearing Scale prolonged procedure, dissociative disorders …), patient refusal, care-related elements preventing the use of the distractibility technique or leading to premature discontinuation of its use.	one month
Secondary	Correlation between patient age and tolerance	The impact of age on abandon (irrespective of the reason) will be noted to search for a link between age and tolerance.	one month
Secondary	Correlation between patient age and treatment efficacy	The impact of age on treatment effect on ANI score during the care procedure will be noted to search for a link between age and treatment efficacy.	one months
Secondary	Correlation between caregiver training level and hypnosis efficacy	Hypnosis training level will be determined by the duration of training (hours) and the professional level (1/2/3). Caregiver category (nurse/psychologist/rehabilitation specialist…) and the number of hypno-therapy sessions delivered during the six months preceding the study will also be considered.	one month
Secondary	Percentage of satisfaction concerning the distractibility techniques.	A questionnaire will evaluate patient perceptions concerning the distractibility techniques.	one month
Secondary	IPQ (Igroup Presence Questionnaire) scale	The IPQ is a 14-item self-administered questionnaire. This scale is used to measure the patient's feelings about spatial presence, the implication and sense of the reality perceived in the virtual reality.	one month