1. Home
  2. Approved trials
  3. » فارسی

Comparison of efficacy of kangaroo mother care, breastfeeding and swaddling on pain score of BCG vaccine in healthy term neonates

Protocol summary

Summary
This research will be done to answer this question that which one of the three non-pharmacological pain management methods (kangaroo mother care, breastfeeding and swaddling), can cause less pain of Bacillus Calmette-Guerin (BCG) vaccine injection. In a clinical trial, 120 healthy term neonates who are to receive BCG vaccine in Shahid Sadoughi Hospital, Yazd, Iran will be randomly distributed into three groups. In group I, breast feeding will be started two minutes before vaccination and continued during and one minute after BCG vaccination. In group II, neonates will receive kangaroo mother care ten minutes before, during and one minute after BCG vaccination and in group III, they will be swaddled ten minutes before, during and one minute after vaccination. In all of them, vaccine will be injected in similar conditions and by a trained person. Primary outcomes include pain score before, during, one minute and two minutes after BCG vaccine injection and obtaining of pain score of less than four during BCG vaccine injection. Pain score will be assessed based on Neonatal/Infant Pain Scale. Secondary outcome will be duration of neonate crying during BCG vaccine injection.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201505142639N16
Registration date: 2015-06-17, 1394/03/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-17, 1394/03/27
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Expected recruitment start date
2015-04-24, 1394/02/04
Expected recruitment end date
2015-06-25, 1394/04/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of kangaroo mother care, breastfeeding and swaddling on pain score of BCG vaccine in healthy term neonates
Public title
Efficacy of kangaroo mother care, breastfeeding and swaddling on BCG vaccine pain score in neonates
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: term neonates (gestation age of 37–42 weeks); birth weight of 2500–4000 g; product of normal vaginal delivery; without systemic illness and with healthy medical condition Exclusion criteria: birth asphyxia; severe congenital malformation; receiving sedative hypnotic drugs within the past 24 hours
Age
From 1 day old to 2 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The trial uses computer generated equal simple randomization by random numbers and data collectors, outcome assessors and data analysts are kept blinded to the allocation.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Street address
Central building of University, Bahonar square
City
Yazd
Postal code
Approval date
2015-04-22, 1394/02/02
Ethics committee reference number
۱۷/۱/۱۷۷۶۲/‍پ

Health conditions studied

1

Description of health condition studied
Vaccination
ICD-10 code
Z27
ICD-10 code description
Need for immunization against combinations of infectious diseases

Primary outcomes

1

Description
Ppain score of BCG vaccine injection
Timepoint
Before, during, one minute and two minutes after BCG vaccine injection
Method of measurement
Neonatal/Infant Pain Scale

2

Description
Obtaining of pain score of less than four during BCG vaccine injection
Timepoint
During BCG vaccine injection
Method of measurement
Neonatal/Infant Pain Scale

Secondary outcomes

1

Description
Duration of neonate crying during BCG vaccine injection
Timepoint
Every 10 seconds after vaccine injection until stopping of crying
Method of measurement
By chronometer

Intervention groups

1

Description
breast feeding two minutes before vaccination until one minute after BCG vaccination
Category
Prevention

2

Description
kangaroo mother care of neonate with close contact of thorax and abdomen skin of mother ten minutes before vaccination until one minute after BCG vaccination
Category
Prevention

3

Description
swaddling of neonate ten minutes before vaccination until one minute after BCG vaccination
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Naeimah Naserzadeh
Street address
Ebn- Sina BlVD, Shahid Ghandi BlVD, Yazd, I.R.Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
Full name of responsible person
Dr. Amirhoshang Mehrparvar
Street address
Central building of University , Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran
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
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Full name of responsible person
Dr.Naeimah Naserzadeh
Position
Pediatric resident
Other areas of specialty/work
Street address
Pediatric Ward, Shahid Sadoughi Hospital, Ebn- Sina BlVD, Shahid Ghandi BlVD, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
dr.Naserzadeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences , Yazd , Iran
Full name of responsible person
Dr.Razieh Fallah
Position
Pediatric Neurologist , Associate Professor
Other areas of specialty/work
Street address
Pediatric Ward, Shahid Sadoughi Hospital, Ebn - Sina BLVD, Shahid Ghandi BlVD, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
dr.raziehfallah@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences , Yazd , Iran
Full name of responsible person
Dr. Razieh Fallah
Position
Pediatric Neurologist , Associate Professor
Other areas of specialty/work
Street address
Pediatric Ward, Shahid Sadoughi Hospital, Ebn - Sina BlVD, Shahid Ghandi BlVD, Yazd, I.R.Iran
City
Yazd
Postal code
Phone
+98 35 3822 4000
Fax
Email
dr.raziehfallah@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...