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Background <p>The high incidence of consciousness disturbance in patients with traumatic brain injury has become a public health and economic concern.</p> <p>Therefore, implementing effective rehabilitation to facilitate awakening in patients with disorders of consciousness 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 disorders of consciousness. Thus, we propose a multi-center randomized study to assess the effectiveness of sensory stimulation with family involvement in improving consciousness in TBI patients.</p> Methods <p>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. The primary outcome is the patient’s consciousness level, evaluated using the Glasgow Coma Scale (GCS). The secondary outcomes include the patient’s consciousness level (assessed by the Coma Recovery Scale-Revised and the Full Outline of Unresponsiveness score) and the occurrence of complications in patients. Data were collected at baseline (T0) and at 1&#xa0;week (T1), 1&#xa0;month (T2), 2&#xa0;months (T3), and 3&#xa0;months (T4) from baseline.</p> Ethics and dissemination <p>The research protocol was approved by the Ethics Committee of Tongji Hospital of Tongji University, prior to commencement. Informed consent will be obtained from the immediate family members of all participants, as they lack decision-making capacity.</p> Trials registration <p>This study was approved by the Ethics Committee of Tongji Hospital of Tongji University (approval number: MR-31–23–050769). And we completed the registration in the Chinese Clinical Trial Registry (approval number: ChiCTR2400080063). </p>

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Effect of family participation in sensory stimulation for patients with disorders of consciousness after traumatic brain injury prognosis: randomized controlled trial protocol

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月26日

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  • Qianqian Cao,
  • Jin Han,
  • Dongmei Tang,
  • Rongqing Li,
  • Jinxia Jiang,
  • Li Zeng

摘要

Background

The high incidence of consciousness disturbance in patients with traumatic brain injury has become a public health and economic concern.

Therefore, implementing effective rehabilitation to facilitate awakening in patients with disorders of consciousness 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 disorders of consciousness. 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. The primary outcome is the patient’s consciousness level, evaluated using the Glasgow Coma Scale (GCS). The secondary outcomes include the patient’s consciousness level (assessed by the Coma Recovery Scale-Revised and the Full Outline of Unresponsiveness score) and the occurrence of complications in patients. Data were collected at baseline (T0) and at 1 week (T1), 1 month (T2), 2 months (T3), and 3 months (T4) from baseline.

Ethics and dissemination

The research protocol was approved by the Ethics Committee of Tongji Hospital of Tongji University, prior to commencement. Informed consent will be obtained from the immediate family members of all participants, as they lack decision-making capacity.

Trials registration

This study was approved by the Ethics Committee of Tongji Hospital of Tongji University (approval number: MR-31–23–050769). And we completed the registration in the Chinese Clinical Trial Registry (approval number: ChiCTR2400080063).