An interventional study of Auditory stimulus and Tactile stimulus in Head Trauma, Traumatic Coma and Nursing Caries, sponsored by Akdeniz University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Akdeniz University · Not applicable, Interventional, and Other
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.
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).
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's planned enrollment of 90 is close to the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Akdeniz University is the lead sponsor of 297 studies on the registry; 62 are open to participants now.
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Exclusion Criteria:
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
Other: Auditory stimulus
Tactile stimulus for patients in this group
Other: Tactile stimulus
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.
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.
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.
Time frame: 1 week
No study locations are listed for this record.
Start is estimated for Jun 2024; primary completion for Oct 2024, 4 months later.
Of 50 non-industry interventional studies with no phase under Craniocerebral Trauma, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's planned 4 months is below that.
Counting every sponsor, half of 51 studies reached it within 26 months; a quarter within 11 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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