Effect of Virtual Reality on Sleep Quality and Stress Load in Critically Ill Patients (VIRES): Study Protocol For A Randomized Controlled Trial

Background: Hospitalization in the Intensive Care Unit (ICU) is associated with significant sleep deprivation and fragmentation caused by environmental factors such as constant noise, perpetual lighting, and frequent nursing interventions. This lack of quality sleep is linked to serious physiological and psychological consequences, including an increased risk of delirium, weakened immune response, and delayed recovery. Virtual Reality (VR) offers an innovative non-pharmacological solution by allowing for sensory isolation from the stressful ICU environment and inducing relaxation through immersive, nature-based scenes. Objectives: The VIRES (VIrtual REality Sleep study) aims to investigate the efficacy and feasibility of immersive VR relaxation for improving both subjective and objective sleep quality while mitigating the physiological stress response in conscious, critically ill patients. Methods: This study is a single-center, prospective, randomized controlled trial (RCT) utilizing a parallel-group PROBE (Prospective Randomized Open Blinded Endpoint) design. A total of 60 participants (30 per group) will be enrolled at the University Hospital Ostrava. The experimental group will undergo a 15–30 minute VR relaxation session (using the Oculus Quest 3 with the VRelax application) for three consecutive evenings (19:00–21:00), while the control group receives standard nursing care. The primary outcome is the comparison of subjective sleep quality using the Richards-Campbell Sleep Questionnaire (RCSQ) and objective sleep parameters (Total Sleep Time and Sleep Efficiency) measured via wrist actigraphy. The secondary outcome involves evaluating the HPA axis activity by measuring the circadian profiles of plasma cortisol and ACTH levels at three specific time points daily. Discussion: By integrating subjective assessments with advanced technological and biochemical markers, the VIRES study seeks to address existing evidence gaps regarding the physiological impact of VR in critical care. The findings may support the implementation of VR as a standard, non-pharmacological intervention to enhance patient comfort and recovery in the ICU. Trial Registration: The study will be registered at ClinicalTrials.gov prior to the start of participant recruitment.