A comparative study of the effect of Iranian and Western classical music on some physiological parameters and the level of consciousness of children aged 1 -6 years admitted to the internal pediatric intensive care units
Comparative determination of the effect of Iranian classical music and Western classical music on some physiological symptoms and level of consciousness of children aged 1-6 years admitted to the pediatric intensive care units
Design
This study is a parallel randomization clinical trial and the intervention groups (there are 2 groups) and the control group are to be investigated simultaneously. In total, information about 45 people will be collected and reviewed. (each group 15 people)
Settings and conduct
The place: Pediatric internal intensive care unites of Namazi Hospital.
And after selecting the samples and randomizing them, Iranian classical music will be played for one group and Western classical music will be played for one group , and no music will be played for the control group. 5 minutes before the start of the music. Treatment of physiological symptoms (heart rate and blood oxygen saturation level) will be recorded, and the patient's level of consciousness will be determined using the Glasgow Coma Scale. In the 15th minute and also 5 minutes after the intervention, the above information will be recorded again.
Participants/Inclusion and exclusion criteria
Entry: The child must be 1-6 years old and be intubated, and the guardian must have the necessary consent and motivation for their child's participation in the research.
Failure to enter: due to the patient's unstable hemodynamic conditions, we cannot play music, and the patient dies.
Intervention groups
In this study, we have three intervention groups.
Group 1: Iranian classical music
Group 2: Western classical music
It will be played through a bluetooth headset and group 3: (control group) and no music will be played. The duration of music playing will be 2 times a day (10-11 in the morning, 15-16 in the evening) and each time will be 30 minutes..
Main outcome variables
Physiological symptoms, level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230921059486N1
Registration date:2023-10-31, 1402/08/09
Registration timing:prospective
Last update:2023-10-31, 1402/08/09
Update count:0
Registration date
2023-10-31, 1402/08/09
Registrant information
Name
Elham Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3225 4074
Email address
elhamghasemi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of Iranian and Western classical music on some physiological parameters and the level of consciousness of children aged 1 -6 years admitted to the internal pediatric intensive care units
Public title
the effects of music therapy in children
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
The child must be 1-6 years old
Be hospitalized in the internal special care departments of Namazi Hospital for children
At least 30 minutes have passed since the last therapeutic intervention of the caregiver
The child should be intubated
Parents should have the necessary satisfaction and motivation for their child's participation in the research
Do not perform any procedures on the patient while listening to music
At least 48 hours have passed since the child was intubated in the intensive care unit
Exclusion criteria:
Due to unstable hemodynamic conditions or cardiac arrest of the patient, we cannot play the music at the appointed time
During music therapy, he needs therapeutic and diagnostic procedures
The patient suffers brain death during the study
Death of the patient
Age
From 1 year old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done by the permutation block method in 4 blocks of 9 with Random Allocation software. The researcher will not know what music is currently playing.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher will select the samples and the research assistant will play the music and the researcher will not know about its type.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fars University of Medical Sciences and Medical Services
Street address
SHiraz., Zand Ave., In front of Palestine Street., Central Building of Shiraz University of Medical Sciences
City
SHiraz
Province
Fars
Postal code
7376144554
Approval date
2023-09-20, 1402/06/29
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.063
Health conditions studied
1
Description of health condition studied
Patients admitted to the intensive care unit of Namazi Hospital