- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06664463
Impact of Sensory Stimulation Techniques on Consciousness Levels
Reviving Hope: Rehabilitation of Traumatic Brain Injury: Nursing Approaches for Arousal Enhancement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Traumatic brain injury (TBI) is a significant global health concern, often leading to long-term disabilities that severely impact daily functioning and quality of life. Patients with traumatic brain injury frequently experience altered states of consciousness, complicating rehabilitation efforts and necessitating innovative approaches to care. Traditional rehabilitation strategies often emphasize physical recovery and may overlook the potential of sensory stimulation in enhancing cognitive function and arousal.
The arousal enhancement protocol represents a promising framework that integrates sensory modalities to actively engage patients in their rehabilitation. By focusing on personalized, nurse-led interventions, this protocol aims to foster greater patient involvement and optimize recovery outcomes. However, there is a pressing need for systematic evaluation of these approaches to better understand their efficacy and long-term impact on patient recovery.
Background Traumatic brain injury is a leading cause of long-term disability, significantly impacting patients' quality of life and daily functioning. Despite advancements in medical care, many individuals with TBI remain in a state of impaired consciousness, complicating their rehabilitation and recovery. Current rehabilitation strategies often lack the integration of nursing approaches specifically aimed at enhancing arousal and responsiveness in these patients. This gap highlights the need for innovative nursing interventions that incorporate structured sensory stimulation techniques to promote neurological recovery. The effectiveness of such approaches in improving arousal levels and cognitive function in patients with traumatic brain injury has not been thoroughly evaluated, necessitating research that explores the role of nursing in implementing arousal enhancement protocols. This study aims to address this issue by assessing the impact of nursing-led sensory stimulation interventions on the recovery outcomes of patients with traumatic brain injury, thereby reinforcing the critical role of nursing in optimizing rehabilitation strategies for this vulnerable population.
The arousal enhancement protocol refers to a series of structured interventions aimed at promoting the recovery of patients with traumatic brain injury who have reduced levels of consciousness. The protocol includes sensory, cognitive, and physical stimulation techniques administered to engage the patient's senses and stimulate brain activity. In this study, techniques such as auditory, visual, olfactory, and tactile stimulation were utilized to increase the responsiveness of patients with traumatic brain injury, ultimately enhancing their cognitive and neurological recovery.
The arousal enhancement protocol encompasses a diverse range of interventions aimed at awakening and engaging individuals who have lapsed into a coma following a traumatic brain injury. These techniques are designed to promote arousal, sensory awareness, and cognitive responsiveness in patients with impaired consciousness. Common approaches include sensory stimulation, such as auditory, visual, olfactory, and tactile stimuli, which were applied in this study in a structured and systematic manner to evoke responses and increase arousal levels.
At the heart of this intervention lies the pivotal role of nursing professionals, whose expertise, compassion, and dedication are instrumental in driving the success of the program. Nursing involvement in the arousal enhancement protocol for traumatic brain injury rehabilitation represents a fusion of clinical skill, therapeutic insight, and patient-centered care. The application of the arousal enhancement protocol in traumatic brain injury rehabilitation represents a pioneering frontier in nursing practice. Throughout the implementation of the arousal enhancement protocol, nurses play a central role in the delivery of sensory stimuli tailored to each patient's unique preferences and responses. From gentle touch and therapeutic massage to auditory stimulation and olfactory cues, nurses harness a diverse array of modalities to engage patients in the rehabilitation process. Their adeptness in therapeutic communication fosters a nurturing and supportive environment conducive to patient participation and progress.
Moreover, nurses play a critical role in the rehabilitation process. They meticulously document changes in arousal levels, vital signs, and behavioral indicators, ensuring that these observations guide timely adjustments to the stimulation protocol. This data-driven approach optimizes the effectiveness of the intervention while mitigating potential risks. Additionally, nurses implement targeted rehabilitation techniques, such as sensory re-education and motor relearning exercises, tailored to the patient's specific needs. They collaborate closely with interdisciplinary team members, including physicians, therapists, and caregivers, to ensure seamless coordination of care and holistic support for patients and their families, thus facilitating a comprehensive and integrated rehabilitation strategy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza
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Cairo, Giza, Egypt, 11562
- Faculy of Nursing Cairo University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 18 and 60 years.
- Suffering from traumatic brain injury.
- With stable vital signs within normal ranges.
- Having a Glasgow Coma Scale (GCS) score of 9 or more.
- Admitted to the inpatient neurology department.
Exclusion Criteria:
- Individuals with a GCS score of less than 9.
- Individuals with deafness, blindness, aphasia, hemiplegia, or quadriplegia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Study group
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Auditory stimulation: Playing familiar music or personalized playlists tailored to the patient's preferences evokes emotional responses and promotes arousal. Olfactory stimulation: Using essential oils or fragrances associated with calming or invigorating properties fosters emotional connections and evokes nostalgia through scents linked to positive memories. Visual stimulation: Displaying photographs of family members or significant events provides comforting visual stimulation and stimulates visual awareness. Tactile stimulation: Gentle touch or therapeutic massage engages the patient through tactile input, promoting physiological and emotional responses. Besid thsi protocl also the will recivce routine care throughout study period The control group in this study will receive routine hospital care. This care includes standard medical evaluations, monitoring of vital signs, neurological assessments, and any necessary imaging (such as CT or MRI scans). Patients will also receive s |
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Placebo Comparator: Control Group
group that will recieve routine hospital care
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The control group in this study will receive routine hospital care.
This care includes standard medical evaluations, monitoring of vital signs, neurological assessments, and any necessary imaging (such as CT or MRI scans).
Patients will also receive supportive care, including pain management, hydration, and nutrition, as well as physical, occupational, or speech therapy as needed based on their recovery progress
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glasgo Coma Scale
Time Frame: 2 weeks
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Severe brain injury: 3-8 Moderate brain injury: 9-12 Mild brain injury: 13-15 |
2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Western Neuro Sensory Stimulation Profile
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arousal Recovery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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