Protocol summary

Summary
Objectives: : During hospitalization in the neonatal intensive care unit, preterm infants are vulnerable against a wide range of stress and stimulation, therefore they need the effective pain management during and after the painful and frequent painful interventions. Design: 4 groups, double blind randomized control trial. Setting and conduct: Neonatal Intensive Care Unit (NICU) of Shahid Akbar Abadi educational & treatment center. Participants: 120 healthy preterm infants with gestational age32-36 weeks; Birth weight over 1500 gr; Apgar score at 1 and 5 min after birth ≥ 7; postnatal age 48 hours or more; Oral feeding, Receiving no sedative drugs during the last 48 hours, will randomly assigned to three experimental groups and control group. Observation of any abnormal physiologic responses; touch and medical or nursing interventions during study; also blood sampling for more than one location; and except of radial and brachial areas, infant will be excluded. Intervention: Two min before blood sampling, in the sucrose group 0.5 ml oral sucrose solution 24% will be administered with a syringe on the anterior portion of the tongue, also, braham`s lullaby will be played for 10 minutes at 40-50 db via earphone in the music group. In the combination group, simultaneously 0.5 ml sucrose 24% will be administered and lullaby music will be played for infants. Physiologic responses and facial changes will be recorded simultaneously with using two video cameras during different phases. For blinding, in control group, 0.5 ml sterile water will be administered with a syringe on the anterior portion of the tongue, the earphone will be used for all groups , meanwhile a research assistant will analyze the films. Main outcome: Pain score will be calculated before blood sampling (base line), 30 seconds after the start of the blood sampling, 30 seconds and 10th min post blood sampling by using the Premature Infant Pain Profile (PIPP).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101052324N7
Registration date: 2012-04-30, 1391/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1813
Email address
keshavarz@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Scienses
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-04-08, 1391/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Music and oral sucrose on Pain During blood sampling in Preterm Infants ,in Neonatal Intensive Care Unite of Shahid Akbarabadi treatment & education center
Public title
Effect of Music and/ or oral sucrose on Pain During blood sampling in Preterm Infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age between 32-36 weeks; Birth weight 1500 grams or more; Apgar score at 1 and 5 min after birth, ≤ 7; Healthy infant (no evidence of congenital anomaly and other diseases); Confirmation of hearing by using ABR device; Have no hyper-responsiveness to the sound in the nursery reports; Non addicted mothers; Postnatal age 48 hours or more; Oral feeding, Receiving no sedative drugs during the last 48 hours. Exclusion criteria: Un willingness the parents for complete the study; Abnormal physiologic responses such as heart rate above 200 beat per min or lower than 100 beat per min, deceleration of oxygen saturation level under 80% during intervention; Any problem to record of physiological and behavioral responses and Observation of any abnormal physiologic responses; touch and medical or nursing interventions during study; Duration of blood sampling more than 4 minutes; Blood sampling is performed in more than one location; ; Blood sampling is performed except radial and brachial areas.
Age
To 1 year old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical commitment of Tehtan University of Medical Sciences
Street address
Sixth floor ,Central office, Ghods St, Keshavarz Blvd- Tehran, Iran
City
Tehran
Postal code
Approval date
2011-11-09, 1390/08/18
Ethics committee reference number
1434

Health conditions studied

1

Description of health condition studied
Pain in preterm newborns
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants

Primary outcomes

1

Description
Pain score in preterm newborns
Timepoint
Before, during and after venipuncture
Method of measurement
by PIPP ( Premature Infant Pain Profile)

Secondary outcomes

empty

Intervention groups

1

Description
1-administration of 0.5 ml oral sucrose solution 24% with a syringe on the anterior portion of the tongue, 2-playing lullaby music for 10 minutes at 40-50 db via earphone 3- lullaby music for 10 minutes at 40-50 db via earphone accompany with 0.5 ml oral sucrose solution 24%
Category
Prevention

2

Description
0.5 ml sterile water will be given to control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar abadi educational & treatment center
Full name of responsible person
Maryam Keshavarz
Street address
Shahid Akbar abadi educational & treatment center , Molavi St. Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research (Research and technology )- Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi- vice chancellor for research of Tehran University of Medical Sciences
Street address
Sixth floor ,Central office, Ghods St, Keshavarz Blvd- Tehran, Iran
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 (Research and technology )- Tehran 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
School of Nursing Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Midwifery dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
Email
Keshavarz_m@tums.ac.ir ; m_keshir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Midwifery dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 6105 4219
Fax
Email
Keshavarz_m@tums.ac.ir ; m_keshir@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Nursing Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Assistant Professor in Midwifery education
Other areas of specialty/work
Street address
Midwifery dep, School of Nursing Midwifery, Tehran University of Medical Sciences, West Nosrat St, Tohid Sq, Tehran.Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Keshavarz_m@tums.ac.ir; m_keshir@yahoo.com
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
Loading...