The Effect of Auditory and Tactile Stimuli in Traumatic Coma
Primary Purpose
Head Trauma, Traumatic Coma, Nursing Caries
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auditory stimulus
Tactile stimulus
Sponsored by
About this trial
This is an interventional other trial for Head Trauma focused on measuring Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma
Eligibility Criteria
Inclusion Criteria:
- Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
- 18 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)
Exclusion Criteria:
- Who are under the age of 18
- Those whose relatives do not agree to participate in the research
- GKS score above 8
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Control group
Auditory stimulus (Intervention A)
Tactile stimulus (Intervention B)
Arm Description
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 for patients in this group
Tactile stimulus for patients in this group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05195606
Brief Title
The Effect of Auditory and Tactile Stimuli in Traumatic Coma
Official Title
The Effect of Auditory and Tactile Stimulus on Consciousness, Oxygen Saturation, and Mean Arterial Pressure in Traumatic Coma Patients: A Randomized Controlled Single-Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Background: One of the most important problems experienced by patients treated in the intensive care unit due to traumatic coma is sensory deprivation.
Aim: In this study, it was aimed to examine the effects of auditory and tactile stimulus to be used in the prevention of sensory deprivation on consciousness, oxygen saturation and mean arterial pressure.
Study Design: The study was planned as a randomized controlled single-blind experiment with three groups. In the study, the patients in the Control group will be given a routine application, the patients in the Intervention A group will be given auditory stimuli, and the patients in the Intervention B group will be treated with tactile stimulus. Interventions will be administered once a day for seven days, for a total of seven times. The "block randomization method" was chosen as the randomization method. In this study, hospitals were taken as a block. An equal number of patients will be recruited from two hospitals and 15 patients will be distributed to three groups from each hospital using the "simple randomization method". 30 patients in each group and 90 patients in total will be included in the study.
Methods: The researcher applied to the patients hospitalized in the intensive care unit for 24-72 hours for seven days, once a day (seven times in total) between 10:00 and 15:00 (Intervention A: 10 minutes of audio recording will be played with headphones. Intervention B: 10 minutes) (5 minutes for one foot) foot massage will be applied. Glaskow Coma Score, oxygen saturation and Mean Arterial Pressure will be measured before and after each intervention (twice daily).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Trauma, Traumatic Coma, Nursing Caries
Keywords
Head trauma, Nursing, Auditory stimulus, Tactile stimulus, Foot massage, Consciousness, Coma
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
In the application process, single blinding will be provided as the patients do not know which group they are included in.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Auditory stimulus (Intervention A)
Arm Type
Experimental
Arm Description
Auditory stimulus for patients in this group
Arm Title
Tactile stimulus (Intervention B)
Arm Type
Experimental
Arm Description
Tactile stimulus for patients in this group
Intervention Type
Other
Intervention Name(s)
Auditory stimulus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tactile stimulus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glasgow Coma Scale (GCS)
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being treated in the intensive care unit for at least 24 hours due to traumatic coma,
18 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)
Exclusion Criteria:
Who are under the age of 18
Those whose relatives do not agree to participate in the research
GKS score above 8
12. IPD Sharing Statement
Learn more about this trial
The Effect of Auditory and Tactile Stimuli in Traumatic Coma
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