| Registry | NCT07537023 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 120 (Actual) |
| Sponsor | Cairo University (Other); collaborators: Prince Sattam Bin Abdulaziz University, Helwan University |
| Conditions | Patients With Traumatic Brain Injury, Coma, Traumatic |
| Interventions | Family-Centered Affective Stimulation (FCAS) (Behavioral) |
| Dates | start 2025-05-02, primary completion 2025-10-30, completion 2025-10-30, first posted 2026-04-17, last updated 2026-06-04 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Patients With Traumatic Brain Injury All trials for Coma, Traumatic All trials of Family-Centered Affective Stimulation (FCAS)
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.
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.
Recent research emphasizes the essential role of family involvement in the rehabilitation process, particularly in providing emotional and affective support. Family-centered care (FCC) has emerged as a key model of care delivery, promoting collaboration between healthcare providers and family members to support patients holistically. FCC has been associated with improved recovery outcomes and may reduce healthcare costs by decreasing the need for prolonged hospital stays or frequent medical interventions. Within this framework, family-centered affective stimulation including structured emotional and psychosocial engagement by family members, has gained attention as an effective strategy to enhance recovery as well as functional outcomes in patients with traumatic brain injury (TBI).
It had been revealed by a systematic review and meta-analysis that it is more efficient to early stimulation family-centered sensory and affective than routine care or nurse-implemented sensory stimulation in terms of enhancing both the level of consciousness and cognitive functioning in comatose patients with traumatic brain injury. Furthermore, the review indicated that in terms of recovery outcomes promotion, multi-sensory stimulation turned out to be more efficient than single-modality stimulation.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention group: Family-Centered Affective Stimulation (FCAS) | Experimental | Behavioral: 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. |
| Control group: Standard care | No intervention |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| Ain Shams University Hospitals | Cairo, Abbasia | Egypt |