CompletedNot Applicable

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

Egypt120 participantsStarted 2025-05-02

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * None

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial used 'family-centered affective stimulation' for coma recovery after traumatic brain injury — can you explain what that type of stimulation actually involves, and whether our family could try something similar as part of my loved one's current care?
2Since this trial has already been completed, have the results been published anywhere, and if so, what did they show about whether family involvement affected coma recovery scores?
3The trial focused on a specific assessment called 'Coma Recovery Assessment' — is that the same tool being used to track my loved one's progress right now, and what would a meaningful improvement on that scale look like?
4Given that this was a Phase NA study — meaning it may have been more focused on feasibility or early evidence — how much confidence can we place in any findings compared to a larger, later-phase clinical trial?
5Are there standard-of-care approaches to stimulation and family involvement for traumatic brain injury coma patients that are already supported by evidence, and how would they compare to what was tested in this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Coma Recovery Assessment

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

Trial details

NCT IDNCT07537023

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Patients With Traumatic Brain Injury trials