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临床试验/NCT07537023
NCT07537023已完成不适用

Family-Centered Affective Stimulation for Patients With Traumatic Brain Injury: Its Effects on Coma Recovery

Cairo University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Coma Recovery Assessment

研究概览

简要总结

Family-centered affective stimulation involves creating an environment in which family members actively participate in the patient's recovery by providing emotional support, positive reinforcement, and a supportive presence. The family-centered affective simulation effects on coma recovery in patients afflicted with traumatic brain injury were the aim of this study.

A quasi-experimental design was employed with 120 patients, who were assigned to either the family stimulation group (n = 60) or the control group (n = 60) in a random manner. Validated instruments, encompassing the Modified Early Warning Score (MEWS), Full Outline of Unresponsiveness (FOUR) score, and Coma Recovery Scale-Revised (CRS-R), were used to assess outcomes of coma recovery. Chi-square tests, independent and paired t-tests, and correlation coefficients were employed to analyze the data.

Following the implementation of family stimulation, highly statistically significant differences were evident in patients' deterioration risk scores, consciousness level scores, and mean coma recovery scores among the studied groups (p = 0.001). Additionally, the family stimulation group showed significant improvement between pre- and post-study phases (p < 0.001).

The application of family-centered organized affective stimulation is an efficient and practical approach to enhance consciousness levels and coma recovery outcomes in comatose patients. Nurses can integrate sensory stimulation into existing therapeutic interventions, either independently or in collaboration with patients' families.

详细描述

Traumatic brain injury poses as remarkable health burden worldwide, with about 69 million cases in the world every year. It can lead to a wide range of cognitive, emotional, and physical impairments, profoundly impacting both patients and their families. Recovery from TBI is a complex and multifaceted process that often requires not only medical and rehabilitative interventions but also comprehensive psychosocial and emotional support.

Acute or severe brain injury is among the most life-threatening consequences related to cerebral hemorrhage or traumatic injury. Prolonged coma is associated with worsening long-term cognitive, behavioral, and emotional impairments, which significantly limit patients' ability to resume normal activities. Multimodal sensory stimulation is an intervention aimed at enhancing arousal, awareness, and behavioral responses through the systematic activation of multiple sensory pathways. Exposure to sensory stimulation has been shown to promote dendritic growth and improve cognitive functioning in addition to social interaction. Accordingly, this study was concerned with determining the impact of multimodal sensory stimulation upon consciousness level across unconscious patients.

Disturbed level of consciousness (DOC) refer to a range of impairments in conscious state that may arise following traumatic brain injury (TBI) or stroke. Consciousness is generally understood to consist of two key elements: wakefulness, indicated by the opening of the eyes in response to external stimuli, and awareness, demonstrated through measurable behavioral and physical reactions. The DOC progression starts within occurrence of injury and continues through the emergency stage to management in the intensive care unit (ICU). The acute stage commonly covers the initial 28 days after the injury occurs. In recent decades, developments in clinical management and neuroscience have fostered greater optimism about the possibility of meaningful recovery for certain patients impacted by TBI.

Traumatic brain injury (TBI) is now widely viewed as a long-term health condition, as accumulating evidence indicates that its consequences can persist for extended periods, particularly in cases of moderate to severe injury. Although many patients with mild TBI experience recovery within a relatively short time, recent research suggests that symptoms in both children and adults may continue for a year or even longer. These observations highlight the importance of enhancing follow-up care and implementing long-term management approaches that are tailored to different age groups.

One emerging scope of interest in TBI recovery is the role of family involvement, particularly through interventions aimed at enhancing affective stimulation. Family-centered care, which places the family at the core of the patient's recovery process, has been identified as a critical component in improving outcomes for individuals with TBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • comprised adult patients admitted to the intensive care unit
  • adults who were diagnosed with traumatic brain injury (TBI)
  • the patients are ranging from mild to severe, with a Glasgow Coma Scale (GCS) score of 5-8
  • the patients without significant co-existing medical or psychiatric conditions that could affect recovery.

排除标准

  • 未提供

结局指标

主要结局

Coma Recovery Assessment

时间窗: baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.

The Coma Recovery Assessment is a standardized tool designed to measure neurobehavioral function

次要结局

  • Modified Early Warning Score (MEWS)(baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.)
  • Full Outline of Unresponsiveness (FOUR) Score(baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed Ahmed Ahmed Elsheikh

Assistant Professor

Cairo University

研究点 (1)

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