Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care

NCT ID: NCT04869553

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-07
• Study Completion Date: 2024-05-24

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ABC's arm

The 3 pain managements are in the ABC's order.

Group Type: EXPERIMENTAL

Management pain with distraction methods ABC

Intervention Type: OTHER

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)

BCA's arm

The 3 pain managements are in the BCA's order.

Group Type: EXPERIMENTAL

Management pain with distraction methods BCA

Intervention Type: OTHER

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)

CAB's arm

The 3 pain managements are in the CAB's order.

Group Type: EXPERIMENTAL

Management pain with distraction methods CAB

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lille Catholic University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Noëlle BARTHOLOMEI, PharmD

Role: STUDY_DIRECTOR

Hôpital Léon Bérard

Locations

Hôpital Léon Bérard

Hyères, , 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

Countries

France

Other Identifiers

RC-P00102

Identifier Type: -

Identifier Source: org_study_id