Trumatic Brain InjuryNCT06664463
Impact of Sensory Stimulation Techniques on Consciousness Levels
A study testing Arousal enhancment protocol and Routine Care in people with Trumatic Brain Injury, run by Cairo University at 1 site in Egypt.
Trial summary
Traumatic brain injury is a leading cause of long-term disability, necessitating innovative rehabilitation methods. This study evaluates the effectiveness of integrating nursing techniques with arousal enhancement protocol to promote neurological recovery in traumatic brain injury patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trumatic Brain Injury
- What is being tested?
- Arousal enhancment protocol and Routine Care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2022to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Individuals with a GCS score of less than 9.
- Individuals with deafness, blindness, aphasia, hemiplegia, or quadriplegia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reviving Hope: Rehabilitation of Traumatic Brain Injury: Nursing Approaches for Arousal Enhancement
Traumatic brain injury is a leading cause of long-term disability, necessitating innovative rehabilitation methods. This study evaluates the effectiveness of integrating nursing techniques with arousal enhancement protocol to promote neurological recovery in traumatic brain injury patients.
Read the 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.
- Conditions
- Trumatic Brain Injury
- Being tested
- Arousal enhancment protocol, Routine Care
- Keywords
- stimulation techniques, Recovery, nursing role
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arousal enhancment protocolOther
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
Routine CareOther
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
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | * This study group will undergo an Arousal Enhancement Protocol, designed to increase physiological and psychological arousal in unconscious patients. Participants will be exposed to controlled stimuli, such as visual or auditory tasks, while their responses are monitored using devices to measure heart rate temparature, blood pressure and respiratory rate.
* No drug interventions are involved in this protocol, with a focus on non-invasive sensory stimulation techniques. The goal is to understand how enhanced arousal affects physiological responses and promotes recovery. Participation is conducted with a focus on safety and strict adherence to ethical guidelines Receives: Other: Arousal enhancment protocol |
| Control Group | Placebo comparator | group that will recieve routine hospital care Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgo Coma Scale
- The Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness following a brain injury. It evaluates three key areas: eye opening, verbal response, and motor response.
- Scoring : The GCS assigns a score in each category, with a total score ranging from 3 to 15, where:
Severe brain injury: 3-8 Moderate brain injury: 9-12 Mild brain injury: 13-15
Measured: 2 weeks
Secondary outcomes (1)
Western Neuro Sensory Stimulation Profile
- The Western Neuro Sensory Stimulation Profile (WNSSP) is a standardized assessment tool used to evaluate the sensory and cognitive responsiveness of patients with severe brain injuries, including traumatic brain injury (TBI). It measures outcomes related to sensory awareness, arousal, and cognitive function by assessing patient responses to various sensory stimuli, such as auditory, visual, tactile, and olfactory cues. The WNSSP provides valuable insights into a patient's level of consciousness and recovery progress, helping clinicians tailor rehabilitation strategies and monitor improvements in responsiveness over time.
- Scoring: The WNSSP has a scoring range from 0 to 113, where higher scores indicate better outcomes. Specifically, higher scores reflect greater levels of sensory awareness and cognitive responsiveness
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start12 Nov 2022
- Primary completion20 Feb 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elsayed Zaky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664463
- Sponsor's protocol ID
- Arousal Recovery
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.
PubMed 35382902
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reviving Hope: Rehabilitation of Traumatic Brain Injury: Nursing Approaches for Arousal Enhancement
- ClinicalTrials.gov ID
- NCT06664463
- Acronym / sponsor ID
- Arousal Recovery
- Conditions
- Trumatic Brain Injury
- Keywords
- stimulation techniques, Recovery, nursing role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traumatic brain injury is a leading cause of long-term disability, necessitating innovative rehabilitation methods. This study evaluates the effectiveness of integrating nursing techniques with arousal enhancement protocol to promote neurological recovery in traumatic brain injury patients.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Other: Arousal enhancment protocol* This study group will undergo an Arousal Enhancement Protocol, designed to increase physiological and psychological arousal in unconscious patients. Participants will be exposed to controlled stimuli, such as visual or auditory tasks, while their responses are monitored using devices to measure heart rate temparature, blood pressure and respiratory rate. * No drug interventions are involved in this protocol, with a focus on non-invasive sensory stimulation techniques. The goal is to understand how enhanced arousal affects physiological responses and promotes recovery. Participation is conducted with a focus on safety and strict adherence to ethical guidelines |
| Control Group | Placebo comparator | Other: Routine Caregroup that will recieve routine hospital care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals with a GCS score of less than 9.
- Individuals with deafness, blindness, aphasia, hemiplegia, or quadriplegia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arousal enhancment protocolAuditory 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 | Other | Study group |
| Routine CareThe 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 | Other | Control Group |
Primary outcome
Glasgo Coma Scale
Time frame: 2 weeks
* The Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness following a brain injury. It evaluates three key areas: eye opening, verbal response, and motor response. * Scoring : The GCS assigns a score in each category, with a total score ranging from 3 to 15, where: Severe brain injury: 3-8 Moderate brain injury: 9-12 Mild brain injury: 13-15
1 secondary outcome
Western Neuro Sensory Stimulation Profile
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 35382902Seo NJ, Ramakrishnan V, Woodbury ML, Bonilha L, Finetto C, Schranz C, Scronce G, Coupland K, Blaschke J, Baker A, Howard K, Meinzer C, Velozo CA, Adams RJ. Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke. Trials. 2022 Apr 5;23(1):262. doi: 10.1186/s13063-022-06241-9.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arousal enhancment protocol and Routine Care in people with Trumatic Brain Injury, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgo Coma Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06664463, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.