Discomfort Improvement for Critically-ill Patients using Electronical Relaxation Devices: results of the Cross Over Randomized Controlled Trial E-CHOISIR (Electronical-CHOIce of a System for Intensive care Relaxation)

Abstract

Purpose: To assess the impact of different electronical-relaxation devices on common patients’ stressful symptoms experienced in Intensive-Care-Unit (ICU).Methods: Sixty critically-ill patients were enrolled in four relaxation-sessions using a randomized cross-over design: standard-relaxation (TV/radio), music-therapy (MUSIC-CARE©), and two virtual-reality systems using either real-motion pictures (DEEPSEN©) or synthetic-motion pictures (HEALTHY-MIND©). The goal was to determine which device was the best to improve overall patient discomfort’s intensity (0-10 Numeric-Rating-Scale (NRS); primary endpoint). Secondary endpoints were specific stressful symptoms (pain, anxiety, dyspnea, thirst, and lack-of-rest-feeling), and stress-response measured by Analgesia/Nociception-Index (ANI). Multivariate mixed-effect analysis was used taking into account patient’s characteristics and multiple measurements.Results: Fifty patients followed the full research-protocol, and ten patients did at least one research-planned session of relaxation. HEALTHY-MIND© was associated with a significant decrease of overall discomfort, the primary endpoint (median NRS=4[2-6] vs. 2[0-5]; p=0.01, mixed-effect model), confirmed by a significant decrease of stress-response (increase of ANI, secondary endpoint; p<0.01). Regarding other secondary endpoints, each of the two virtual-reality systems was associated with a decrease of anxiety (p<0,01), while HEALTHY-MIND© was associated also with a decrease of pain (p=0.001) and DEEPSEN© with a decrease of lack-of-rest (p=0.01). Three incidents (claustrophobia/dyspnea/agitation) were reported among 109 virtual-reality sessions. Cybersickness was rare (NRS=0[0-0]).Conclusion: Electronical relaxation therapy is a promising, safe and effective non-pharmacological solution that can be used to improve overall discomfort in ICU patients. Its effectiveness depends on technical characteristics (real or synthetic imagined world, association or not with music-therapy), as well as the type of symptoms.