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

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.

Study Overview

• Status: Completed
• Conditions: Coma, Traumatic; Patients With Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Family-Centered Affective Stimulation (FCAS)

Detailed Description

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 [ 1 ].

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 [2].

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 [3].

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 [4].

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 [5].

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) [5, 6 ,7].

It had been revealed by a systematic review and meta-analysis conducted by Zou et al. (2021) 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 to be more efficient than single-modality stimulation [8].

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11591
      • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• The inclusion criteria for this study comprised adult patients admitted to the intensive care unit at Ain Shams University Hospital, Cairo, Egypt, 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, and without significant co-existing medical or psychiatric conditions that could affect recovery.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coma Recovery Assessment	The Coma Recovery Assessment is a standardized tool designed to measure neurobehavioral function	baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.

Secondary Outcome Measures

Outcome Measure	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.	baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.
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. 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.	baseline before the intervention and post-intervention after the implementation of 6 months of family-centered affective stimulation.

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Helwan University; Prince Sattam Bin Abdulaziz University
• Investigators: Study Chair: Walid Elsayed Hemaida, PhD, Prince Sattam bin Abdulaziz University

Publications and helpful links

General Publications

• 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.
• 24. Tien HY, Su JS, Yu WY, Pan ML, Yang YC, Chiou YJ, et al. Leveraging the modified early warning score (MEWS) in rapid response teams to predict and prevent ICU readmissions. J Formos Med Assoc. 2025. doi:10.1016/j.jfma.2025.06.009.
• 21. 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;10(3):1601-1610. doi:10.1002/nop2.1412.
• 18. 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. 2022;9. doi:10.3389/fmed.2022.931304.
• 16. Weaver JA, Cogan AM, O'Brien KA, Hansen P, Giacino JT, Whyte J, et al. 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;39(19-20):1417-1428. doi:10.1089/neu.2022.0095.
• 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.
• 8. 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;115:103846. doi:10.1016/j.ijnurstu.2020.103846.
• 7. Cheng L, Cortese D, Monti MM, Wang F, Riganello F, Arcuri F, et al. Do sensory stimulation programs have an impact on consciousness recovery? Front Neurol. 2018;9. doi:10.3389/fneur.2018.00826.
• 5. Carrier SL, Ponsford J, McKay A. Family experiences of supporting a relative with agitation during early recovery after traumatic brain injury. Neuropsychol Rehabil. 2024;34(4):510-534. doi:10.1080/09602011.2023.2219064.
• 3. Edlow BL, Claassen J, Schiff ND, Greer DM. Recovery from disorders of consciousness: mechanisms, prognosis and emerging therapies. Nat Rev Neurol. 2021;17(3):135-156. doi:10.1038/s41582-020-00428-x.
• 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).
• 1. 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;110(6):3760-3767. doi:10.1097/JS9.0000000000001391.

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Affective Stimulation, Coma Recovery, Consciousness Level, Family-Centered Care, Traumatic Brain Injury.
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Neurobehavioral Manifestations; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Consciousness Disorders; Unconsciousness; Coma; Brain Injuries, Traumatic; Coma, Post-Head Injury
• Other Study ID Numbers: HUNURSERC42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
• IPD Sharing Time Frame: The data will be submitted to the data repository platform. It will be selected based on the journal recommendations during the peer review process.
• IPD Sharing Access Criteria: Data will be available publicly. Anonymous data. data related to study variables.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No