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IRCT20180602039947N1 IRCT 2018-08-07 Mashhad University of Medical Sciences Investigating the Effect of Music Composition Program with Family Memory Remedies on the Level of consciousness and cognitive function MPWFR The effect of the combined music program with family reminiscence on level of consciousness and cognitive function of Patients With Traumatic Brain Injury In Intensive Care Unit 2018-08-23 anticipated 30 Complete https://irct.ir/trial/31757 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Considering that coma is one of the traces of traumatic brain injury and patients suffering from changes in level of consciousness and functional skills for a period of time Therefore, non-medical interventions can be used to stimulate patients in coma after severe brain damage, as non-invasive, low-risk, low-cost interventions for patients with coma Among these non-medical interventions that enhance awareness and arousal of the patient in coma, live performance and playback of music In this way, a music program with family memories that includes a frequent reminder of past events and past experiences of the patient's personal life is recounted and mused by the family, then the headache is traumatized to the patient Ultimately, the patient's alertness will be measured using the Glasgow table and cognitive function using the RLA, Randomization description: Patients are entered into the study on the basis of entry criteria, and then divided into two intervention and control groups based on random block assignment (quadruple blocks). The number of samples in this study will be 30 people, Blinding description: The blinding process will be such that the researcher or researcher does not know about the allocation of patients to the two intervention and control groups. Also, patients will be unaware from that in which one of the study groups Also, the statistics consultant who is responsible for analyzing information is unaware of the allocation of individuals to study groups. N/A Traumatic Brain Injury. Intervention 1: Intervention group:Patients in the intervention group the combined music program with family reminiscence, in which a music program featuring family memories frequent reminders of events and past experiences of the patient's personal life is recounted and mused by the family, then a head trauma is traumatic to the patient. Intervention 2: Control group:The control group will be patients who, apart from the usual sounds of the environment and possibly GCS that check the patient, do not receive any other stimuli. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of secondery data analysis
public Razieh Frootan
ŮŽAhmad abad Avenue
Mashhad Iran (Islamic Republic of) 12345678 +98 51 3859 1511 Froutanr@mums.ac.ir Mashhad University of Medical Sciences scientific Razieh Frootan
Ahmad abad Avenue
Mashhad Iran (Islamic Republic of) 656314-99817 +98 513605484 Froutanr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Hospital less than 3 days Age (60-14) Brain trauma patients with GCS less than 8 Not having a history of delirium, dementia and admission to a mental hospital Stable hemodynamic status of patients in terms of water and electrolyte Not having hearing impairment that prevents you from hearing music through the headphones Satisfied to participate in the study. Not having a skull fracture or bleeding or surgery in the temporal region Not having aethera or reneur No swelling of both eyelids or both eyes 14 years 60 years Both Incomplete or corrupted patient records Sending the patient to other treatment centers Unwillingness to continue cooperation in the study The hemodynamic status of patients in terms of water and electrolyte is unstable So6 Incranial injury Other Other Intervention group:Patients in the intervention group the combined music program with family reminiscence, in which a music program featuring family memories frequent reminders of events and past experiences of the patient's personal life is recounted and mused by the family, then a head trauma is traumatic to the patient Control group:The control group will be patients who, apart from the usual sounds of the environment and possibly GCS that check the patient, do not receive any other stimuli Level of consciousness in patients with traumatic brain injury. Timepoint: Patient Level of consciousness using Glasgow's coma table 5 minutes before and 10 and 30 minutes after the combined music program with family reminiscence is performed Will be measured. Method of measurement: By Glasgow coma scale (GCS). Level of Cognitive Function of Patients. Timepoint: Using Rancho Los Amigos Scale, the cognitive function of patients 5 minutes before and 10 and 30 minutes after the combined music program with family reminiscence is performed Will be measured. Method of measurement: By Rancho Los Amigos Scale. Mashhad University of Medical Sciences Approved 2018-08-03 The Ethics Committe of Mashhad University of Medical Sciences Ahmadabad Ave Faculty of Nursing and Midwifery of Mashha Mashhad Razavi Khorasan Iran (Islamic Republic of)