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

NCT07537023 | Completed DMC

• 1 other identifier: HUNURSERC42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Patients With Traumatic Brain Injury; Coma, Traumatic

Keywords

effective stimulation; Coma Recovery; Consciousness Level; Family-Centered Care; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Modified Early Warning Score (MEWS)

  Two timepoints, : T0 at baseline and at T1 at 6 months

• Full Outline of Unresponsiveness (FOUR) Score

  Two timepoints, : T0 at baseline and at T1 at 6 months

Study Arms (2)

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.

Behavioral: Family-Centered Affective Stimulation (FCAS)

Control group: Standard care

NO INTERVENTION

Interventions

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.

Intervention group: Family-Centered Affective Stimulation (FCAS)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Cairo University: lead
• Prince Sattam Bin Abdulaziz University: collaborator
• Helwan University: collaborator

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, 11591, Egypt

Location

Related Publications (13)

• 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.

  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.

  PMID: 40494742 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.

  PMID: 36303273 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.

  PMID: 36203763 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.

  PMID: 35570725 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.

  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.

  PMID: 33485101 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.

  PMID: 30333789 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.

  PMID: 37332244 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.

  PMID: 33318675 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).

  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.

  PMID: 38573135 BACKGROUND

MeSH Terms

Conditions

Coma, Post-Head Injury; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Walid Elsayed Hemaida, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: May 2, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: June 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• Access Criteria: Data will be available publicly. Anonymous data. data related to study variables.

Locations

EG (1)