家庭中心情感刺激对创伤性脑损伤患者的影响:对昏迷恢复的作用
以家庭为中心的情感刺激对创伤性脑损伤患者的影响:对昏迷复苏的作用
以家庭为中心的情感刺激是指创造一个环境,让家庭成员通过提供情感支持、积极强化和陪伴支持,积极参与患者的康复过程。 本研究旨在探讨以家庭为中心的情感刺激对创伤性脑损伤患者昏迷恢复的影响。
研究采用准实验设计,纳入120例患者,随机分配至家庭刺激组(n=60)或对照组(n=60)。 使用经过验证的工具评估昏迷恢复结果,包括改良早期预警评分(MEWS)、全面无反应性评分(FOUR)和修订版昏迷恢复量表(CRS-R)。 采用卡方检验、独立和配对t检验以及相关系数进行数据分析。
实施家庭刺激后,研究组间患者的恶化风险评分、意识水平评分和平均昏迷恢复评分均显示出高度统计学显著差异(p=0.001)。 此外,家庭刺激组在研究前与后阶段之间表现出显著改善(p<0.001)。
应用以家庭为中心的有组织情感刺激是一种有效且实用的方法,可提高昏迷患者的意识水平和昏迷恢复效果。 护士可将感觉刺激整合到现有治疗干预中,既可独立实施,也可与患者家属协作开展。
研究概览
详细说明
创伤性脑损伤在世界范围内构成显著的医疗负担,全球每年约有6900万病例。它可能导致广泛的认知、情感和身体功能障碍,对患者及其家庭产生深远影响。创伤性脑损伤的恢复是一个复杂且多方面的过程,通常不仅需要医疗和康复干预,还需要全面的心理社会和情感支持[1]。
急性或重度脑损伤是与脑出血或创伤性损伤相关的最具生命威胁的后果之一。长期昏迷与长期认知、行为和情感功能障碍的恶化相关,显著限制了患者恢复正常活动的能力。多模式感官刺激是一种干预措施,旨在通过系统激活多个感觉通路来增强觉醒、意识和行为反应。除了社交互动外,感官刺激已被证明能促进树突生长并改善认知功能。因此,本研究关注于确定多模式感官刺激对无意识患者意识水平的影响[2]。
意识障碍水平是指创伤性脑损伤或中风后可能出现的意识状态的一系列损害。意识通常被理解为由两个关键要素组成:觉醒性,表现为对外部刺激睁开眼睛的反应;意识性,通过可测量的行为和身体反应来证明。意识障碍的进展从损伤发生开始,持续到紧急阶段,再到重症监护室的管理。急性阶段通常涵盖损伤发生后的最初28天。近几十年来,临床管理和神经科学的进展使人们对某些受创伤性脑损伤影响的患者实现有意义恢复的可能性更加乐观[3]。
创伤性脑损伤现在被广泛视为一种长期健康状况,因为越来越多的证据表明其后果可能持续较长时间,尤其是在中度至重度损伤的情况下。尽管许多轻度创伤性脑损伤患者在相对较短的时间内恢复,但最近的研究表明,儿童和成人的症状可能持续一年甚至更长时间。这些观察结果强调了加强随访护理和实施针对不同年龄组定制的长期管理方法的重要性[4]。
创伤性脑损伤恢复中一个新兴的关注领域是家庭参与的作用,特别是通过旨在增强情感刺激的干预措施。以家庭为中心的护理将家庭置于患者恢复过程的核心,已被确定为改善创伤性脑损伤个体预后的关键组成部分[5]。
最近的研究强调了家庭参与在康复过程中的重要作用,特别是在提供情感和情感支持方面。以家庭为中心的护理已成为一种关键的护理提供模式,促进医疗保健提供者与家庭成员之间的合作,以全面支持患者。以家庭为中心的护理与改善的恢复结果相关,并可能通过减少长期住院或频繁医疗干预的需求来降低医疗成本。在此框架内,以家庭为中心的情感刺激,包括家庭成员结构化的情感和心理社会参与,已成为增强创伤性脑损伤患者恢复和功能结果的有效策略[5,6,7]。
Zou等人(2021年)进行的系统回顾和荟萃分析揭示,在提高创伤性脑损伤昏迷患者的意识水平和认知功能方面,早期以家庭为中心的感官和情感刺激比常规护理或护士实施的感官刺激更有效。此外,该回顾表明,在促进恢复结果方面,多感官刺激比单模式刺激更有效[8]。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Abbasia
-
Cairo、Abbasia、埃及、11591
- Ain shams university hospitals
-
-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
纳入标准:
- 本研究纳入标准包括在埃及开罗Ain Shams大学医院重症监护室收治的、被诊断为创伤性脑损伤(TBI)的成年患者
- 患者病情从轻度到重度不等,格拉斯哥昏迷评分(GCS)为5-8分,且无可能影响恢复的显著共存内科或精神疾病。
排除标准:
- 无
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Intervention group: Family-Centered Affective Stimulation (FCAS)
The intervention phase involved the systematic implementation of Family-Centered Affective Stimulation (FCAS).
Family members were guided to provide structured emotional and sensory stimulation, including verbal communication, familiar voices, emotional reassurance, and gentle touch, in accordance with the prescribed protocol.
The intervention was administered for a specified duration and frequency, under continuous clinical supervision to ensure patient safety and adherence to the protocol.
During the intervention period, patients were continuously monitored, and periodic assessments were conducted to evaluate their responses.
Changes in level of consciousness, behavioral reactions, and physiological parameters were observed and documented at regular intervals.
The research team closely supervised the sessions to ensure consistency and provided ongoing support to participating family members.
Any adverse responses or deviations from the protocol were promptly recorded and addressed.
|
根据规定的方案,指导家庭成员提供结构化的情感和感官刺激,包括语言交流、熟悉的声音、情感安抚和轻柔的触摸。
干预措施在持续临床监督下按规定的持续时间和频率进行,以确保患者安全和方案依从性。
在干预期间,对患者进行持续监测,并定期进行评估以评估其反应。
定期观察并记录意识水平、行为反应和生理参数的变化。
研究团队密切监督干预过程以确保一致性,并为参与的家庭成员提供持续支持。
任何不良反应或偏离方案的情况都会被及时记录和处理。
|
|
无干预:Control group: Standard care
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Coma Recovery Assessment
大体时间:Two timepoints, : T0 at baseline and at T1 at 6 months
|
The Coma Recovery Assessment is a standardized tool designed to measure neurobehavioral function.
The Coma Recovery Scale-Revised (CRS-R) is a reference standard for assessing neurobehavioral function and diagnosing disorders of consciousness.
It is made up by six subscales: auditory, visual, motor, or motor/verbal, communication, and arousal.
The items of CRS-R as well as rating scale categories were refined to enhance clinical utility, construct validity, and diagnostic accuracy.
Each subscale follows a hierarchical scoring system, with higher scores indicating greater neurobehavioral function.
The number of scoring categories differs across the subscales.
For example, the communication subscale includes three response options (0, 1, and 2), while the motor subscale contains seven categories ranging from 0 to 6. Consequently, the total raw score of the CRS-R can vary between 0 and 23.
|
Two timepoints, : T0 at baseline and at T1 at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Modified Early Warning Score (MEWS)
大体时间:Two timepoints, : T0 at baseline and at T1 at 6 months
|
The Modified Early Warning Score (MEWS) provides a simple and practical model for measuring risk of illness deterioration, with higher scores indicating an increased likelihood of clinical decline.
Vital signs and level of consciousness are assessed on a five-point scale ranging from 0 to 4. The scoring system was adopted from Veldhuis et al. to assess physiological parameters and identify early indicators of deterioration, including vital signs and level of consciousness.
This Early Warning Score (EWS) provides a simple and practical model for evaluating illness severity, with higher scores indicating an increased likelihood of clinical decline.
Vital signs and level of consciousness are assessed on a five-point scale ranging from 0 to 4. Total scores are categorized as follows: 0-4, low risk of deterioration; 5-6, moderate risk; and ≥7, high risk, requiring immediate clinical attention
|
Two timepoints, : T0 at baseline and at T1 at 6 months
|
|
Full Outline of Unresponsiveness (FOUR) Score
大体时间:Two timepoints, : T0 at baseline and at T1 at 6 months
|
The Full Outline of Unresponsiveness (FOUR) score is a recently validated coma scale used to evaluate the level of consciousness.
The Full Outline of Unresponsiveness (FOUR) score is a recently validated coma scale used to evaluate the level of consciousness.
It was adopted from Wijdicks et al. (2005).
The scale consists of four components, each with a maximum score of four: eye response (E4), motor response (M4), brainstem reflexes (B4), and respiration (R4).
Each component is scored on a five-point scale ranging from 0 to 4. Total scores are interpreted as follows: 15-16, conscious; 8-14, semiconscious; and 0-7, unconscious.
The FOUR score provides a comprehensive assessment of neurological function, including bra
|
Two timepoints, : T0 at baseline and at T1 at 6 months
|
合作者和调查者
调查人员
- 学习椅:Walid Elsayed Hemaida, PhD、Prince Sattam Bin Abdulaziz University
出版物和有用的链接
一般刊物
- Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021 Mar;17(3):135-156. doi: 10.1038/s41582-020-00428-x. Epub 2020 Dec 14.
- Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, Di H, Schnakers C. Do Sensory Stimulation Programs Have an Impact on Consciousness Recovery? Front Neurol. 2018 Oct 2;9:826. doi: 10.3389/fneur.2018.00826. eCollection 2018.
- 25. Peterson AB, Thomas KE, Zhou H. Surveillance report of traumatic brain injury-related deaths by age group, sex, and mechanism of injury-United States, 2018 and 2019.
- 13. Chandrasekharan S, Sreedharan J, Gopakumar A. Statistical issues in small and large sample: Need of optimum upper bound for the sample size. Int J Comput Theor Stat. 2019;6(2):108-118.
- 11. Maciejewski ML. Quasi-experimental design. Biostat Epidemiol. 2020;4(1):38-47. doi:10.1080/24709360.2018.1477468.
- 2. Lewis CC, Lobo D. Effectiveness of the multi-modal sensory stimulation on the level of consciousness among unconscious patients. J Health Allied Sci NU. 2026;16:26. doi:10.25259/JHS-2024-3-5-R4-(1280).
- Adineh M, Elahi N, Molavynejad S, Jahani S, Savaie M. Impact of a sensory stimulation program conducted by family members on the consciousness and pain levels of ICU patients: A mixed method study. Front Med (Lausanne). 2022 Sep 20;9:931304. doi: 10.3389/fmed.2022.931304. eCollection 2022.
- Zuo J, Tao Y, Liu M, Feng L, Yang Y, Liao L. The effect of family-centered sensory and affective stimulation on comatose patients with traumatic brain injury: A systematic review and meta-analysis. Int J Nurs Stud. 2021 Mar;115:103846. doi: 10.1016/j.ijnurstu.2020.103846. Epub 2020 Dec 7.
- Tien HY, Su JS, Yu WY, Pan ML, Yang YC, Chiou YJ, Chen CY, Wu CK, Chen HM, Chen CY, Huei-Ming Ma M. Leveraging the Modified Early Warning Score (MEWS) in rapid response teams to predict and prevent ICU readmissions. J Formos Med Assoc. 2025 Jun 9:S0929-6646(25)00283-9. doi: 10.1016/j.jfma.2025.06.009. Online ahead of print.
- Ahmed FR, Attia AK, Mansour H, Megahed M. Outcomes of family-centred auditory and tactile stimulation implementation on traumatic brain injured patients. Nurs Open. 2023 Mar;10(3):1601-1610. doi: 10.1002/nop2.1412. Epub 2022 Oct 27.
- Weaver JA, Cogan AM, O'Brien KA, Hansen P, Giacino JT, Whyte J, Bender Pape T, van der Wees P, Mallinson T. Determining the Hierarchy of Coma Recovery Scale-Revised Rating Scale Categories and Alignment with Aspen Consensus Criteria for Patients with Brain Injury: A Rasch Analysis. J Neurotrauma. 2022 Oct;39(19-20):1417-1428. doi: 10.1089/neu.2022.0095. Epub 2022 Jun 16.
- Carrier SL, Ponsford J, McKay A. Family experiences of supporting a relative with agitation during early recovery after traumatic brain injury. Neuropsychol Rehabil. 2024 May;34(4):510-534. doi: 10.1080/09602011.2023.2219064. Epub 2023 Jun 18.
- Muili AO, Kuol PP, Jobran AWM, Lawal RA, Agamy AA, Bankole NDA. Management of traumatic brain injury in Africa: challenges and opportunities. Int J Surg. 2024 Jun 1;110(6):3760-3767. doi: 10.1097/JS9.0000000000001391.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- HUNURSERC42
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.