Impact of Sensory Stimulation Techniques on Consciousness Levels

NCT06664463 | Completed

• 1 other identifier: Arousal Recovery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trumatic Brain Injury

Keywords

stimulation techniques; Recovery; nursing role

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (1)

• Western Neuro Sensory Stimulation Profile

  2 weeks

Study Arms (2)

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

Other: Arousal enhancment protocol

Control Group

PLACEBO COMPARATOR

group that will recieve routine hospital care

Other: Routine Care

Interventions

Arousal enhancment protocol OTHER

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

Study group

Routine Care OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Individuals with a GCS score of less than 9.
• Individuals with deafness, blindness, aphasia, hemiplegia, or quadriplegia.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculy of Nursing Cairo University

Cairo, Giza Governorate, 11562, Egypt

Location

Related Publications (1)

• 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.

  PMID: 35382902 RESULT

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investiagtor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 29, 2024
• Study Start: November 12, 2022
• Primary Completion: February 20, 2023
• Study Completion: July 20, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)