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
Determination 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
Design
The present study is a randomized clinical trial with parallel, three-blind, and control group that was conducted on 30 patients With Traumatic Brain Injury admitted to the ward of Shahid Kamyab Hospital in Mashhad.Patients were randomly divided into two groups by software before the intervention stage
Settings and conduct
A research project in the intensive care unit of Shahid Kamyab Hospital in Mashhad, a researcher-specialized center in Mashhad University of medical sciences in the field of accidents and trauma During the study a research project in the intensive care unit of Shahid Kamyab Hospital in Mashhad, a researcher-specialized center in Mashhad University of medical sciences in the field of accidents and trauma
Participants/Inclusion and exclusion criteria
Patients admitted to the intensive care unit after traumatic brain injury with level of consciousness of less than 8 and sustained hemodynamic status in terms of water and electrolyte were enrolled. At the end of the study, patients whose their hodynamic status were unstable in terms of water and electrolyte were excluded.
Intervention groups
Patients in the intervention group receive the combined music program with family reminiscence. This combined music program with family reminiscence featuring frequent reminders of events and good experiences of the patient's past personal life is recounted and broadcasted through the headphone. The control group will be the patients who, apart from the usual sounds of environment and possibly GCS that check the patients, do not receive any other stimuli.
Main outcome variables
Level of consciousness in patients with Traumatic Brain and their cognitive function
General information
Reason for update
Acronym
MPWFR
IRCT registration information
IRCT registration number:IRCT20180602039947N1
Registration date:2018-08-07, 1397/05/16
Registration timing:prospective
Last update:2018-08-07, 1397/05/16
Update count:0
Registration date
2018-08-07, 1397/05/16
Registrant information
Name
Hamid Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5232 3726
Email address
hoseinihm951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the Effect of Music Composition Program with Family Memory Remedies on the Level of consciousness and cognitive function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 14 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Triple blinded
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
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committe of Mashhad University of Medical Sciences
Street address
Ahmadabad Ave Faculty of Nursing and Midwifery of Mashha
City
Mashhad
Province
Razavi Khorasan
Postal code
123456758
Approval date
2018-08-03, 1397/05/12
Ethics committee reference number
IR.MUMS.NURSE.REC.1397.016
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
So6
ICD-10 code description
Incranial injury
Primary outcomes
1
Description
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)
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Other
2
Description
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
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care unit of Shahid Kamyab Hospital in Mashhad
Full name of responsible person
Razieh Frootan
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
1234567
Phone
+98 51 3859 1511
Email
froutanr@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tappaghdi
Street address
َAhmad abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
3512345678
Phone
+98 51 4464 9561
Email
hoseinihm951@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Frootan
Position
Faculty trainer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
َAhmad abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
12345678
Phone
+98 51 3859 1511
Email
Froutanr@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Frootan
Position
Faculty trainer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahmad abad Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
656314-99817
Phone
+98 513605484
Email
Froutanr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Razieh Frootan
Position
Faculty trainer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ahmad Abad avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
12345678
Phone
+98 513605484
Email
froutanr@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD