Using hypnosis and virtual reality to manage pain
Analgesic Efficacy of Hypnosis and Virtual Reality in Repetitive Pain Care : a Controlled, Randomised, Cross-over, Open-label, Multi-centre Study
This study tests whether using hypnosis or virtual reality can help people feel less pain during medical procedures when regular pain medications aren't enough.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Lille Catholic University Academic / other |
| Locations | 8 sites (Hyères and 7 other locations) |
| Trial ID | NCT04869553 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of hypnosis and virtual reality as distraction techniques for managing pain in various healthcare settings. It aims to evaluate how these methods can reduce pain perception during painful interventions, such as wound dressings or mobilization. The study employs a cross-over design, allowing patients to experience both interventions in a real-life context, thus providing insights into their efficacy across different types of care situations. By focusing on patients who still experience pain despite standard analgesic protocols, the study seeks to explore alternative pain management strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 15 and older who experience significant pain during medical interventions despite standard pain relief measures.
Not a fit: Patients with cognitive or psychiatric disorders that hinder communication or understanding, or those with certain serious medical conditions affecting the nervous system, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer patients safer and more effective pain management options without the risks associated with traditional analgesics.
How similar studies have performed: While the use of distraction techniques like hypnosis and virtual reality in pain management is gaining interest, this specific comparative approach in diverse clinical settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hyères and 7 other locations
- Hôpital Léon Bérard — Hyères, France (Recruiting)
- Centre médico-chirurgical des Massues — Lyon, France (Withdrawn)
- USSAP - Centre Bouffard Vercelli — Perpignan, France (Recruiting)
- Centre Mutualiste de Kerpape — Ploemeur, France (Recruiting)
- Pôle MPR Saint Hélier — Rennes, France (Recruiting)
- Fondation ILDYS - Site de Perharidy — Roscoff, France (Recruiting)
- Fondation Ellen Poidatz - Centre de Rééducation Fonctionnelle — Saint-Fargeau-Ponthierry, France (Withdrawn)
- SSR Pédiatrique Marc Sautelet — Villeneuve-d'Ascq, France (Recruiting)
Study contacts
- Study coordinator: Marie Paule Lebitasy
- Email: Lebitasy.Marie-Paule@ghicl.net
- Phone: 03 20 22 52 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.