The management of pain and anxiety using virtual reality during the care of elderly hospitalized patients: Study protocol for a randomized controlled trial

Abstract Background : The medical environment can generate stressful and anxiety-provoking situations for patients, particularly during painful care procedures for the older population. These stressful environments have deleterious effects on the quality of care and can even put the patient at risk and set the care team up for failure. The search for a solution is therefore imperative. The development of new technologies such as virtual reality (VR) seems to be an answer to this problem. The objective of this study is to compare the effects of virtual reality on pain and anxiety when caring for elderly hospitalized people, with the effects of usual care. More precisely, different individual factors (age, cognitive level, individual preferences, etc.) and different virtual reality universes (personalized or non-personalized) will be studied to understand the role of these factors in reducing pain and anxiety during care procedures. The aim of this study is to improve the quality of life of patients and caregivers in their work environment. Method : This mono-centered, randomized, controlled study will be conducted on 120 participants recruited from the geriatric departments of the Cimiez Hospital, Nice, France. Participants will be randomized into three groups: control group, personalized VR group and non-personalized VR group. Each participant will be followed during a painful care session, and pain and anxiety assessments will be performed before, during and immediately after the care session. Physiological assessments with an oximeter will also be performed to collect heart rate and respiratory rate measurements. Statistical analyses will allow us to compare the effects of the VR conditions with the control condition and we will also analyze the effects of a personalized VR environment versus a non-personalized environment. Discussion : This research aims to evaluate the effectiveness of a personalized and non-personalized virtual reality intervention in relieving pain and anxiety among older hospitalized individuals and compare it with standard care. Finally, the experiences of healthcare professionals involved will also be considered to assess the impact of these interventions on working conditions and patient support. Trial registration : ClinicalTrials.gov, NCT05759026. Registered on March 8, 2023.