The aim of this study is to determine the effect of music therapy on pain responses of premature infants during and following blood sampling. This is an experimental study with cross- over design which was conducted on 20 premature infants hospitalized in intensive care unit of a hospital affiliated to Tehran University of Medical Sciences. Infants were randomly studied once as experiment and once as control, so each infant was considered as its own control to eliminate the influence of individual characteristics. Researcher assessed the pain responses caused by blood sampling in preterm infants. Physiological and behavioral responses of pain were assessed. We assessed heart rate and oxygen saturation level as physiological responses and we assessed sleep wake state and facial expressions (which was measured by neonatal facial coding system) as behavioral responses. In the intervention group transitions music was used from 5 minutes before blood sampling and continued until 10 minutes after blood sampling. At any time (experience or control) recording with two cameras was done from 10 minutes before sampling, during blood sampling and 10 minutes after sampling. One camera recorded facial expressions and body movements and at the same time another camera recorded the monitor of the infant. Then the films were reviewed by computer and physiological and behavioral changes were detected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138905034372N2
Registration date:2011-12-08, 1390/09/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-12-08, 1390/09/17
Registrant information
Name
Roghieh Karimi
Name of organization / entity
Nursing School of Tehran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
karimirg@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of music therapy on pain responses of blood sampling in premature infant
Public title
Effect of music therapy on pain responses of blood sampling in premature infant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: premature infants whose weights are less than 2500 grams, gestational age 29- 36 weeks, no congenital diseases, no intracranial hemorrhage or neurological disorders, level 1 or 2 of neonatal intensive care, not receiving any sedative in 24 hours before sampling, arterial sampling should be necessary for the infant, the site of sampling should not be the same in two times of sampling
Exclusion criteria: no willingness to continue, becoming unstable during sampling, first time failure for trial to sampling
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Review Committee of Tehran University of Medical Sciences
Street address
Floor 6, Central Building of Tehran University ,Intersection of Ghods & Keshavarz Blv
City
tehran
Postal code
Approval date
2010-08-07, 1389/05/16
Ethics committee reference number
623/130/ص/89
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain responses to blood sampling in premature infant
Timepoint
10 minutes before sampling to 10 minutes after sampling
Method of measurement
recording physiologic and behavioral signs of pain each 15 second by watching films recorded from monitor and face of infant
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Music therapy, starting from 5 minutes before sampling to 10 minutes after sampling
Category
Behavior
2
Description
Control group: no intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-asr hospital
Full name of responsible person
Fidan Shabani
Street address
Nosrat street, East side of Tohid sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Yunesiyan
Street address
floor 6, central bulding of university , Ghods, Keshavarz Blv.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research, Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing School of Tehran University of Medical Sciences and Health Services
Full name of responsible person
Fidan Shabani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Nosrat street, East side of Tohid sq.
City
Tehran
Postal code
Phone
+98 21 4423 7092
Fax
Email
fidannahal@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing School of Tehran University of Medical sciences and Health Services
Full name of responsible person
Roghieh Karimi
Position
Master of Science in Nursing/faculty member
Other areas of specialty/work
Street address
Nosrat street, East side of Tohid sq.
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
karimirg@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Fidan Shabani
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)