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Comparison of the effect of massage and breastfeeding on response to pain due to venipuncture among hospitalized neonates in NICUs of selected hospitals of Esfahan University of Medical Sciences 2012.

Protocol summary

Summary
Among hospitalized neonates in NICUs of selected hospitals of Isfahan University of Medical Sciences 2012. Background: Untreated procedural pain, lead to long-term and short-term complications in neonates. The role of nurses in pain management and reduce this complications is very important and essential. Preventing of pain in sick and acute neonates, not only is legal duty, but also decreases psychological and even neurological complications in the future. So, it is essential for nurses to prevent or treat pain in neonates. The aim of this study is to compare effects of massage and breast milk on pain of the neonates. Aim: to comparethe effect of massage and breastfeeding on response to pain due to venipuncture among hospitalized neonates in NICUs of selected hospitals of Isfahan University of Medical Sciences. Objectives: 1- Determine and compare the mean venipucture pain score, between massage and control groups. 2- Determine and compare the mean venipucture pain score, between massage and beast feeding groups. 3- Determine and compare the mean venipucture pain score, between breastfeeding and control groups. 4- Determine and compare the mean venipucture pain score, between breastfeeding and massage and control groups. Implications for practice: Suggestion of using an effective and suitable non-pharmacological way for reduce venipucture pain, in order to provides a simple, low cost alternative intervention in reduce venipuncture pain. Study questions: 1- What is the mean venipuncture pain in massage group? 2-What is the mean venipuncture pain in breastfeeding group? 3- What is the mean venipuncture pain in control group? Hypothesis: 1- Mean pain score is deferent in massage and breastfeeding groups. Mean pain score in breastfeeding group is higher than control group. Method and statistical analyses: This was a quasi-experimental study with 75 term& near term infants requiring a venipuncture were studied. Infants were randomly allocated to one of the following treatment groups: group 1, breastfeeding (n = 25); group 2, massage (n= 25); group 3, control (n = 25). In the first group (breastfed group), mothers were asked to be in a comfort position and take their infants in their arms and feed them with their milk.Venipuncture was done two minutes after breastfeeding. In the 2nd group(massage), neonates received massage for 3 minutes and Venipuncture was done two minutes after massage. The Neonatal Infant Pain Scale (NIPS) used for measurement of pain score at the first 30 seconds of venipuncture. Data analyzed with SPSS software using t-test and one-way analysis of variance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013020212346N1
Registration date: 2013-06-10, 1392/03/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-06-10, 1392/03/20
Registrant information
Name
Azamolmolouk Elsagh
Name of organization / entity
Isfahan University of Medical Sience
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2964
Email address
a_elsagh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sience
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of massage and breastfeeding on response to pain due to venipuncture among hospitalized neonates in NICUs of selected hospitals of Esfahan University of Medical Sciences 2012.
Public title
The effect of massage in reduce pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being awake; term or near term; gestational agemore than 34 Weeks; no problem for breast feeding; having experience of breast feeding; no sings of cerebral palsy or chromosomal disorder and asphyxia and no crying before venipuncture. Exclusion criteron: aspiration or apnea that make study impossible.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
NlA

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Siences
Street address
Hezar Jarib Ave- Isfahan
City
Isfahan
Postal code
8174673461
Approval date
2012-10-10, 1391/07/19
Ethics committee reference number
391294

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R07.2
ICD-10 code description
Precordial pain

Primary outcomes

1

Description
Pain
Timepoint
Before and during doing venipuncture
Method of measurement
NIPS Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1 breast feeding : the sample breastfed for 5 minutes before sampling. When BF become completed, neonate lying supine position on the examination table.
Category
Prevention

2

Description
Control group: the neonates lying on the examination table without intervention.
Category
Prevention

3

Description
Massage group: the sample was lying on the examination table and recieve eflorage technique of massage by researcher hand's for 5 minutes before venipuncture.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Azahra Hos
Full name of responsible person
Zargham-Boroujeni, Ali,
Street address
Isfahan- Hezarjarib Ave- Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery
City
Isfahan

2

Recruitment center
Name of recruitment center
Shahid Beheshti Hos
Full name of responsible person
DR zargham
Street address
Isfahan- Hezarjarib Ave- Nursing and Midwifery Care Research Center, Faculty of Nursing and Midwifery
City
Isfahan

3

Recruitment center
Name of recruitment center
Amiralmomenin Hos
Full name of responsible person
DR zargham
Street address
Shahreza- Pasdaran Ave
City
Shahreza

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University Medical Science- vice chancellor for research, faculty of Nursing and Miwifery
Full name of responsible person
Maryam Kianpour
Street address
Hezarjarib Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University Medical Science- vice chancellor for research, faculty of Nursing and Miwifery
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
Isfahan University of Medical Siences
Full name of responsible person
Dr Ali Zargham. Broujeni
Position
MSc, PhD. Assistant Professor
Other areas of specialty/work
Street address
Isfahan University Of Medical Sience - Hezarjarib Avenue
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2964
Fax
Email
zargham@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Siences
Full name of responsible person
Dr Ali Zargham. Broujeni
Position
MSC, PhD. Assistant Professor
Other areas of specialty/work
Street address
Isfahan University Of Medical Sience - Hezarjarib Avenue
City
Isfahan
Postal code
8174673461
Phone
+98 79 22964
Fax
Email
azargham@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Azamolmolouk Elsagh
Position
MSC student.NeonatalIntensive careNursing student
Other areas of specialty/work
Street address
No 33- 24 Ave- Amirkabir St.
City
Shahreza
Postal code
86149-56113
Phone
+98 32 1222 9055
Fax
Email
azamolmolouk@yahoo.com; a_elsagh@nm.mui.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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