Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care

NCT04869553 | Completed

• 1 other identifier: RC-P00102
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 5

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.

Conditions

Pain

Keywords

Pain management; Hypnosis; Virtual Reality; Distractibility methods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• ANI's average score (Analgesia Nociception Index) 5 minutes after the care and the distractibility methods

  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

Study Arms (3)

ABC's arm

EXPERIMENTAL

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

Other: Management pain with distraction methods ABC

BCA's arm

EXPERIMENTAL

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

Other: Management pain with distraction methods BCA

CAB's arm

EXPERIMENTAL

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

Other: Management pain with distraction methods CAB

Interventions

Management pain with distraction methods ABC 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)

ABC's arm

Management pain with distraction methods BCA 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)

BCA's arm

Management pain with distraction methods CAB 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)

CAB's arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing care interventions of a given type (e.g. wound dressings/mobilization/…) recognized as painful (pain VAS \>3 despite the usual analgesic protocol)
• Patient age ≥15 years
• Informed consent from patient or legal guardian
• Beneficiary of the French healthcare fund

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (5)

Hôpital Léon Bérard

Hyères, 83418, France

Location

USSAP - Centre Bouffard Vercelli

Perpignan, 66962, France

Location

Centre Mutualiste de Kerpape

Ploemeur, 56275, France

Location

Pôle MPR Saint Hélier

Rennes, 35043, France

Location

Fondation ILDYS - Site de Perharidy

Roscoff, 29684, France

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Marie-Noëlle BARTHOLOMEI, PharmD

  Hôpital Léon Bérard

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: January 7, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)