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

Affective 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

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

Secondary Outcomes (2)

• 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.

Study Arms (2)

Intervention group

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

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

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  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

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  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

• 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.

  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: April 17, 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)