The Effect of Auditory and Tactile Stimuli in Traumatic Coma
NCT ID: NCT05195606
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2024-06-15
2024-12-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Control group
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.
No interventions assigned to this group
Auditory stimulus (Intervention A)
Auditory stimulus for patients in this group
Auditory 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 (Intervention B)
Tactile stimulus for patients in this group
Tactile stimulus
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.
Interventions
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Auditory 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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Those whose relatives do not agree to participate in the research
* GKS score above 8
18 Years
ALL
No
Sponsors
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Akdeniz University
OTHER
Responsible Party
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Arş. Gör. Arzu TAT ÇATAL
Principal Investigator
Other Identifiers
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KAEK-724
Identifier Type: -
Identifier Source: org_study_id
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