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

Lille Catholic University

Status: Completed

Conditions: Pain

Treatments: Other: Management pain with distraction methods BCA; Other: Management pain with distraction methods CAB; Other: Management pain with distraction methods ABC

Study type: Interventional

Funder types: Other

Identifiers

NCT04869553

RC-P00102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

52 participants in 3 patient groups

ABC's arm

Experimental group

Description:

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

Treatment:

Other: Management pain with distraction methods ABC

BCA's arm

Experimental group

Description:

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

Treatment:

Other: Management pain with distraction methods BCA

CAB's arm

Experimental group

Description:

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

Treatment:

Other: Management pain with distraction methods CAB