Ignite Creation Date:
2024-05-06 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05195606
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2021-12-29
Brief Title:
The Effect of Auditory and Tactile Stimuli in Traumatic Coma
Sponsor:
Akdeniz University
Organization:
Akdeniz University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1000 and 1500 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
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 1000 and 1500 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None