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Comparison of the effect of breast feeding, sucking the pacifier and being in mother's hug on pain during infant's immunization injection

Protocol summary

Summary
The objective of this study was to examine the pain relieving effect of breast-feeding, pacifier use or being in mother's hug and routine of health centers clinics during immunization injections in healthy neonates. This controlled trial study, was performed on 152 healthy term infants with 2- 4 months old, which was brought to the health centers of Iran University of Medical Sciences in west of Tehran by their mother and had DPT immunization. One group were breast-fed, 2 minutes before, during, and 15 seconds after the injection, and second group were used pacifier while held by mothers, 2 minutes before, during, and 15 seconds after the injection, third group were in their mother's hug 2 minutes before, during, and 15 seconds after the injection and control group according to routine clinic lied on the examining table. Objective changes in appearance of Neonates were assessed by Modified Behavioral Pain Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008284002N2
Registration date: 2010-09-23, 1389/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-09-23, 1389/07/01
Registrant information
Name
Shadab Shahali
Name of organization / entity
Academic centre of education, culture and research (ACECR), Iran University of medical sciences bran
Country
Iran (Islamic Republic of)
Phone
+98 21 8879 7403
Email address
shahali@irmed.org
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2007-03-20, 1385/12/29
Expected recruitment end date
2008-03-19, 1386/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of breast feeding, sucking the pacifier and being in mother's hug on pain during infant's immunization injection
Public title
Comparison of the effect of breast feeding, sucking the pacifier and being in mother's hug on pain during infant's immunization injection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion/Exclusion: 1. neonate should be awake 2. Neonate pad shouldn't be wet 3. neonate used to breast feed and suck pacifier 4. Neonate or its mother shouldn't use sedative drugs for 48 hours 5. Neonate shouldn't be fed 30 minutes before DPT vaccination 6. Neonate shouldn't be hospitalized for disease or surgery. Minimum age: 2 month, Maximum age: 4 month
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 152
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
Iran University of Medical Sciences
Street address
Hemmat high way
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
498

Health conditions studied

1

Description of health condition studied
prevention of pain
ICD-10 code
Z00-Z99
ICD-10 code description
Factors influencing health status and contact with health services

Primary outcomes

1

Description
pain relieving
Timepoint
2 minutes before, during, and 15 seconds after the injection
Method of measurement
Modified Behavioral Pain Scale

Secondary outcomes

empty

Intervention groups

1

Description
First group were breast-fed, 2 minutes before, during, and 15 seconds after the injection
Category
Prevention

2

Description
Third group were in their mother's hug 2 minutes before, during, and 15 seconds after the injection
Category
Prevention

3

Description
Second group were used pacifier while held by mothers, 2 minutes before, during, and 15 seconds after the injection
Category
Prevention

4

Description
Control group according to routine clinic lied on the examining table
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers in west of Tehran
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
DR. Seid Abbas Motevalian
Street address
Hemmat highway, near Milad Hospital
City
Tehran
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
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
Iran University of Medical Sciences
Full name of responsible person
Shadab Shahali
Position
M. Sc in Midwifery
Other areas of specialty/work
Street address
Hemmat highway, near Milad Hospital
City
Tehran
Postal code
Phone
+98 21 8879 7403
Fax
Email
shadabshahali@yahoo.com , shahali@irmed.org
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Simin Taavoni
Position
M. Sc in Midwifery
Other areas of specialty/work
Street address
Hemmat highway, near Milad Hospital
City
Tehran
Postal code
Phone
+98 21 8247 1114
Fax
Email
staavoni14@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Shadab Shahali
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)
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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