Clinical Trial

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

Completed
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-12.
Trial Details
NCT Number NCT07537023
Lead Sponsor Cairo University
Collaborators: Prince Sattam Bin Abdulaziz University, Helwan University
Conditions Patients With Traumatic Brain Injury, Coma, Traumatic
Enrollment 120 participants
Start Date 2025-05-02
Primary Completion 2025-10-30 (estimated)
Study Completion 2025-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-04