Effect of Family Participation in Sensory Stimulation for Patient with consciousness disorder after TBI Prognosis: Randomized Controlled Trial Protocol

Effect of Family Participation in Sensory Stimulation for Patient with consciousness disorder after TBI Prognosis: Randomized Controlled Trial Protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Effect of Family Participation in Sensory Stimulation for Patient with consciousness disorder after TBI Prognosis: Randomized Controlled Trial Protocol Qianqian Cao, Jin Han, Li Zeng, Jinxia Jiang, Dongmei Tang, Rongqing Li This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4157313/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version 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). Sensory stimulation Traumatic brain injury Consciousness disorder Randomized controlled trial Study protocol Full Text Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4157313","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":286020460,"identity":"f9852770-e36a-46a2-8428-272663408b38","order_by":0,"name":"Qianqian Cao","email":"","orcid":"","institution":"Tongji Hospital Affiliated to Tongji University","correspondingAuthor":false,"prefix":"","firstName":"Qianqian","middleName":"","lastName":"Cao","suffix":""},{"id":286020461,"identity":"adc2933e-1547-44b8-85e5-3f1c362665f4","order_by":1,"name":"Jin Han","email":"","orcid":"","institution":"General Hospital ofTianjin Medical 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protocol","lastPublishedDoi":"10.21203/rs.3.rs-4157313/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4157313/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eThe high incidence of consciousness disturbance in patients with traumatic brain injury (TBI) has become a public health and economic concern. \u003cbr\u003e\n 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e 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. 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