Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care (PADIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Management pain with distraction methods ABC; Other: Management pain with distraction methods BCA; Other: Management pain with distraction methods CAB

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hyères, France, 83418
    • Hôpital Léon Berard
  • Perpignan, France, 66962
    • USSAP - Centre Bouffard Vercelli
  • Ploemeur, France, 56275
    • Centre Mutualiste de Kerpape
  • Rennes, France, 35043
    • Pole MPR Saint Hélier
  • Roscoff, France, 29684
    • Fondation ILDYS - Site de Perharidy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABC's arm; The 3 pain managements are in the ABC's order.	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)
Experimental: BCA's arm; The 3 pain managements are in the BCA's order.	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)
Experimental: CAB's arm; The 3 pain managements are in the CAB's order.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Percentage of satisfaction concerning the distractibility techniques.	A questionnaire will evaluate patient perceptions concerning the distractibility techniques.	one month
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

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Study Director: Marie-Noëlle BARTHOLOMEI, PharmD, Hôpital Léon Berard

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Actual): May 24, 2024
• Study Completion (Actual): May 24, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Hypnosis; Pain management; Virtual Reality; Distractibility methods
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Agnosia; Anesthesia and Analgesia; Analgesia
• Other Study ID Numbers: RC-P00102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No