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Comparing the effect of listening to music therapy and swaddling on neonate’s physiological and pain intensity changes during blood sampling in the neonatal intensive care unit

Protocol summary

Summary
The aim of this study was to compare the effect of music therapy and Swaddling on pain is caused by venous blood sampling in premature babies. This clinical trial on 51 premature an infant hospitalized in neonatal intensive care medical center will Bushehr Persian Gulf. Inclusion criteria included: Written take informed consent from parents, Gestational age less than 37 weeks, After at least 24 hours of birth, Exclusion criteria: Congenital abnormalities, Chromosomal or neurologic, Babies who have Undergone surgery, Babies who are connected to ventilator.Infants randomly were divided into three groups of 17 subjects in each block ; Music group a, The Swaddling group b and group c was considered as control; From 5 minutes before blood sampling, Blood samples collected during and 5 minutes after music player in group a and group b 5 minutes before and 5 minutes after blood sampling, The Baby wrapped in a thin sheet. In all three groups the heart rate and arterial oxygen saturation before, During and after the blood sample is measured and will be recorded.The baby's face in close-up shooting can be seen, a film made by a research assistant unaware of the type of intervention , Then questionnaire of premature infant pain profile is completed by a research assistant. To measure physiological parameters, a pulse oximetry is connected to baby is used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017040433209N1
Registration date: 2017-05-28, 1396/03/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-28, 1396/03/07
Registrant information
Name
Aliakbar karimi
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3559
Email address
a.karimi@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Bushehr University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of listening to music therapy and swaddling on neonate’s physiological and pain intensity changes during blood sampling in the neonatal intensive care unit
Public title
The effect of music therapy and swaddling on neonatal pain when taking blood.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Written take informed consent from parents; Gestational age less than 37 weeks; After at least 24 hours of birth; After maximum of one month of birth; Apgar score above 6 in the first 5 minutes; Awake and calm baby; Do not feed the baby 30 minutes before the intervention; Do not receive any medication or substance of analgesics and sedatives during the 6 hours before the intervention; The absence of rash (dry skin, red spots, hemangiomas) in infants; In addition, Collected blood samples in the same day was the first time an infant sampling and sampling has not been done before Exclusion criteria: Congenital abnormalities; Chromosomal or neurologic; Intraventricular hemorrhage, Seizures, Epilepsy; Babies who have Undergone surgery, Babies who are connected to ventilator
Age
From 1 day old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Bushehr University of Medical Sciences
Street address
No. 12, Bahmani, Yasini Avenue,Bushehr University of Medical Sciences Campus, Iran, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
ir.bpums.rec.1395.165

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
Timepoint
5 Minutes before blood sampling, Blood sampling during and 5 minutes after the blood sampling
Method of measurement
Premature infant pain profile questionnaire

2

Description
Behavior
Timepoint
5 Minutes before blood sampling, Blood sampling during and 5 minutes after the blood sampling
Method of measurement
Premature infant pain profile questionnaire

Secondary outcomes

1

Description
Heart rate
Timepoint
5 Minutes before blood sampling, Blood sampling during and 5 minutes after the blood sampling
Method of measurement
Pulse oximetry and Premature infant pain profile questionnaire

2

Description
Arterial blood oxygen saturation
Timepoint
5 Minutes before blood sampling, Blood sampling during and 5 minutes after the blood sampling
Method of measurement
Pulse oximetry and Premature infant pain profile questionnaire

Intervention groups

1

Description
Baby diapers clean without clothes and only one heating device placed under then 5 minutes before blood sampling, Blood sampling during and 5 minutes after the blood sample the music is played.
Category
Prevention

2

Description
Infant without clothes and only with a clean diaper, By the researcher in a thin linen wrapped in swaddling clothes.
Category
Prevention

3

Description
The control group, Infants in this group receive all routine care during hospitalization.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Central Bushehr Persian Gulf Martyrs
Full name of responsible person
Doctor Alireza Hajyvny
Street address
City
Bushehr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,bushehr University of Medical Sciences
Full name of responsible person
Afshin ostovar doctor
Street address
NO 12, Campus of Medical Sciences,Bahamni, Yasini Avenue, Bushehr Bushehr
City
bushehr
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,bushehr University of Medical Sciences
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
Bushehr University of Medical Sciences
Full name of responsible person
sherafat Akaberian
Position
Master / faculty
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
bushehr
Postal code
7514633341
Phone
+98 77 3345 0187
Fax
Email
Sh.akabarian@bpums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
sherafat akaberian
Position
Master / faculty
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
bushehr
Postal code
7514633341
Phone
+98 77 3345 0178
Fax
Email
Sh.akabarian@bpums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
ali akbar karimi
Position
Other areas of specialty/work
Street address
NO 7, School of Nursing and Midwifery,Bahmani, Yasini st, Bushehr
City
bushehr
Postal code
Phone
00
Fax
Email
a.karimi@bpums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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