Effects of music interventions on occupational performance of premature infants
Design
The study is a single blinded clinical trial in which the samples are selected by convenience sampling and then divided into two groups of experimental and control based on birth weight through stratified randomization. The sample size based on similar studies and formula is 15 for each group.
Settings and conduct
The research will performed in the neonatal intensive care unit of Akbarabadi Hospital affiliated to Iran University of Medical Sciences in Tehran. With written consent from the infant caregiver or ward manager, first the demographic information questionnaire and then the Test of Infant Motor Performance and Neonatal Behavioral Assessment Scale by the blind assessor to the groups it'll be done. After the interventions, the tests will be repeated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The corrected age of the premature infant should be less than 2 months and more than 36 weeks of the fetal and infants have not any accompanying problems.
Exclusion criteria: instability of the infant during the intervention.
Intervention groups
Infants in the control group will receive routine care and in the treatment group, music interventions will be used in addition to routine care that will play through headphones and very simple non-verbal music is used with a frequency of 20-50 Hz and volume about 50 dB. 12 sessions are performed for 3 weeks and 4 times a week, and each session lasts about 20 minutes.
Main outcome variables
Motor performance, Behavioral performance
General information
Reason for update
Acronym
NICU
IRCT registration information
IRCT registration number:IRCT20191109045380N1
Registration date:2021-06-29, 1400/04/08
Registration timing:registered_while_recruiting
Last update:2021-06-29, 1400/04/08
Update count:0
Registration date
2021-06-29, 1400/04/08
Registrant information
Name
Parinaz Tofighi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3331 3617
Email address
tofigi.p@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of music interventions on occupational performance of premature infants hospitalized in the neonatal intensive care unit
Public title
Effects of music interventions on occupational performance of premature infants hospitalized
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Corrected age less than 2 months and more than 36 weeks of gestation
Satisfaction of the infant's parent
Participating in intervention session by the approval of the ward nurse
Exclusion criteria:
The infant does not feeding by tube
The baby does not connect to the device for breathing
No cerebral hemorrhage of third degree and above
No other accompanying problems including: severe hypoglycemia, seizures, meningitis, encephalitis, asphyxia, sepsis.
Age
From 1 day old to 60 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be select by the convenience sampling and by stratified randomization in two birth weight floors are 1500 to 2000 grams and 2000 to 2500 grams using quadri-blocks. Then will divide into two experimental and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessors who are allocated to gather data.
Placebo
Not used
Assignment
Parallel
Other design features
Musical interventions are provided in addition to the routine cares.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Faculty of Rehabilitation Iran University of Medical Sciences, Mirdamad St., Madar Sq., Shahid Shahnazari St., Madadkaran St., Farjam St., Faculty of Rehabilitation Sciences
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.IUMS.REC.1400.094
Health conditions studied
1
Description of health condition studied
Premature infant over 36 weeks of gestation
ICD-10 code
P07.39
ICD-10 code description
Preterm newborn, gestational age 36 completed weeks
2
Description of health condition studied
Infants weighing 2000 grams to 2500 grams
ICD-10 code
P07.18
ICD-10 code description
Other low birth weight newborn, 2000-2499 grams
3
Description of health condition studied
Babies weighing 1750 grams to 2000 grams
ICD-10 code
P07.17
ICD-10 code description
Other low birth weight newborn, 1750-1999 grams
4
Description of health condition studied
Babies weighing 1500 grams to 1750 grams
ICD-10 code
P07.16
ICD-10 code description
Other low birth weight newborn, 1500-1749 grams
Primary outcomes
1
Description
Motor performance
Timepoint
Before the intervention, the end of the twelfth session in the third week
Method of measurement
Test of Infant Motor Performance
2
Description
Behavioral performance
Timepoint
Before the intervention, the end of the twelfth session in the third week
Method of measurement
Neonatal Behavioral Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receiving music interventions in addition to routine care interventions. Musical interventions are played through headphones, and very simple non-verbal music is used in the frequency range of 20-50 Hz and volume about 50 dB. 12 intervention sessions are performed for 3 weeks and 4 times a week, and each session lasts about 20 minutes.
Category
Rehabilitation
2
Description
Control group: Infants in the control group will receive routine care, including nursing, medical, and rehabilitation interventions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi hospital
Full name of responsible person
Dr Majid Kalani
Street address
Bagh Ferdows Station, Molavi Crossroads, Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Fax
+98 21 5560 8012
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice-chancellor for Research
Street address
Fifth floor of the headquarters, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Fax
+98 21 8862 2703
Email
research-m@iums.ac.ir
Web page address
https://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parinaz Tofighi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Maddakaran St., Shah Nazari St., Mother Square, Mirdamad Street, Faculty of Rehabilitation Sciences.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
tofigi.p@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Mitra Khalafbeigi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad.madar sq.shahnazari street.rehabilitation science of iran university
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
0098 21 22222059 388
Fax
Email
khalafbeigi.m@iums.ac.ir
Web page address
https://rehab.iums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parinaz Tofighi
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Maddakaran St., Shah Nazari St., Mother Square, Mirdamad Street, Faculty of Rehabilitation Sciences.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Fax
+98 21 2222 0946
Email
tofigi.p@iums.ac.ir
Web page address
https://rehab.iums.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
There is no more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data that are related to primary outcome will be available.
When the data will become available and for how long
Immediately after publication.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
Performing similar research
From where data/document is obtainable
Search databases or sending Email to Dr Mitra Khalafbeigi: khalafbeigi.m@iums.ac.ir
What processes are involved for a request to access data/document