The Effect of Auditory and Tactile Stimuli in Traumatic Coma

NCT05195606 | Unknown

• 1 other identifier: KAEK-724
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.

Conditions

Head Trauma; Traumatic Coma; Nursing Caries

Keywords

Head trauma; Nursing; Auditory stimulus; Tactile stimulus; Foot massage; Consciousness; Coma

Outcome Measures

Primary Outcomes (1)

• Glasgow Coma Scale (GCS)

  GCS is a diagnostic tool that provides objective evaluation of the patient's eye-opening, verbal and motor response to stimuli. In the scale, the eye opening score is between 1-4, the verbal response is between 1-5, and the motor response is between 1-6, and the total score is between 3-15. The GCS score of the patient who did not respond to painful stimuli, could not open his eyes spontaneously, and had complete loss of muscular tone was three; The GCS score of the patient who is oriented, spontaneously opens his eyes and fulfills the orders is 15. It should be understood that the patient with a GCS score of less than eight is in a coma.

  1 week

Study Arms (3)

Control group

NO INTERVENTION

There is no standard sensory stimulation program for comatose patients with head trauma in the hospitals where the research will be conducted. Therefore, the control group will receive routine practice.

Auditory stimulus (Intervention A)

EXPERIMENTAL

Auditory stimulus for patients in this group

Other: Auditory stimulus

Tactile stimulus (Intervention B)

EXPERIMENTAL

Tactile stimulus for patients in this group

Other: Tactile stimulus

Interventions

Auditory stimulus OTHER

Auditory stimulus will be applied to the patients in intervention group A. For the auditory stimulus, the sound recording of the relatives of the patients will be taken and the patients will be listened to with headphones.

Auditory stimulus (Intervention A)

Tactile stimulus OTHER

Tactile stimulus will be applied to the patients in the intervention group B. The tactile stimulus will be performed by the researcher with a foot massage to be applied to the patient.

Tactile stimulus (Intervention B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
• years and older
• Relatives of those who agreed to participate in the study
• GCS score between 3-8 (GCS: 3-8 indicates coma)
• Without hearing impairment
• Having no authority for auditory stimulus
• No problem for foot massage (Lower extremity fracture, infection)

You may not qualify if:

• Who are under the age of 18
• Those whose relatives do not agree to participate in the research
• GKS score above 8

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Craniocerebral Trauma; Coma, Post-Head Injury; Coma

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In the application process, single blinding will be provided as the patients do not know which group they are included in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: January 19, 2022
• Study Start: June 15, 2024
• Primary Completion: October 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01