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

NCT07537023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-06-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Prince Sattam Bin Abdulaziz University

    collaborator OTHER
  • Helwan University

    collaborator OTHER
  • Cairo University

    lead OTHER

Principal Investigators

  • Walid Elsayed Hemaida, PhD · Prince Sattam Bin Abdulaziz University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07537023 on ClinicalTrials.gov