Abstract
Background: The high incidence of consciousness disturbance in patients with traumatic brain injury (TBI) has become a public health and economic concern.
Hence, implementing effective rehabilitation to facilitate awakening in patients with consciousness disorders is essential.Sensory stimulation, recognized as safe, effective, and affordable, is gaining attention for awakening patients. Additionally, involving family in sensory stimulation is believed to enhance consciousness levels in TBI patients with consciousness disorders. Thus, we propose a multi-center randomized study to assess the effectiveness of sensory stimulation with family involvement in improving consciousness in TBI patients.
Methods: A multi-center randomized controlled trial with a 3-month follow-up is set in Shanghai and Taicang, Jiangsu, China. Control group participants will receive standard neurosurgical care, whereas the intervention group will get standard care plus a family-involved sensory stimulation program covering vision, hearing, touch, taste, smell, body position, and emotional inputs. Primary outcomes include the patient's consciousness level, evaluated using the Glasgow Coma Scale, Coma Recovery Scale-Revised, and Global Unresponsiveness Scale.The secondary outcomes were designed to assess the occurrence of complications in patients. Data were collected at baseline (T0), one week after the intervention (T1), one month after the intervention (T2), two months after the intervention (T3), and three months after the intervention (T4).
Conclusion: If the intervention measures are found to be effective, this study will have important reference values for standardizing the implementation of sensory stimulation with the participation of family members and provide data support for standardizing the sensory stimulation of patients with traumaticbrain injury, as well as clinical evidence for high-level guidelines and expert consensus.
Trials registration:This study was approved by the Ethics Committee of the Shanghai Tongji Hospital(approval number:MR-31-23-050769).And we completed the registration in the Chinese Clinical Trial Registry(approval number:ChiCTR2400080063).