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| Name | Class |
|---|---|
| Prince Sattam Bin Abdulaziz University | OTHER |
| Helwan University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: Family-Centered Affective Stimulation (FCAS) | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-Centered Affective Stimulation (FCAS) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Coma Recovery Assessment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Early Warning Score (MEWS) | 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Walid Elsayed Hemaida, PhD | Prince Sattam Bin Abdulaziz University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Abbasia | 11591 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 40494742 | Background | 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. | |
| 36303273 |
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The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
Data will be available publicly. Anonymous data. data related to study variables.
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| ID | Term |
|---|---|
| D020207 | Coma, Post-Head Injury |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D003128 | Coma |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
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| Two timepoints, : T0 at baseline and at T1 at 6 months |
| Full Outline of Unresponsiveness (FOUR) Score | 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 |
| Background |
| 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. |
| 36203763 | Background | 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. |
| 35570725 | Background | 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. |
| Background | 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. |
| Background | 11. Maciejewski ML. Quasi-experimental design. Biostat Epidemiol. 2020;4(1):38-47. doi:10.1080/24709360.2018.1477468. |
| 33485101 | Background | 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. |
| 30333789 | Background | 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. |
| 37332244 | Background | 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. |
| 33318675 | Background | 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. |
| Background | 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). |
| 38573135 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |