This study is a single blind - randomized clinical trial. 128 infants allocated randomly and systematically in 4 groups (breast feeding, massage, seed and control group). The study population for vaccination HB and DTP in 6 months and MMR in 12 months of all infants who referred to one of the health center in Isfahan. Data gathering was done by questionnaire and checklist (neonatal infant pain scale, NIPS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021815525N2
Registration date:2014-08-11, 1393/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-08-11, 1393/05/20
Registrant information
Name
Mitra Savabi Esfahani
Name of organization / entity
Department of Midwifery, School on Nursing and Midwifery, Isfahan University of Medical science.
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2971
Email address
m_savabi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-04-13, 1390/01/24
Expected recruitment end date
2011-06-14, 1390/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of vaccination-related pain in massage therapy, seed therapy and breastfeeding during injection in infants
Public title
Comparison of vaccination-related pain in massage therapy, seed therapy and breastfeeding in infants.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:full consciousness infants;taking no medication; lack of any disease; regularly visit infants with Iranian nationality.
Exclusion criteria: if he/she was crying and it was impossible to be quiet before injection.
Age
From 1 year old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hezarjerip Ave,research vice chancelor,Isfahan University of medical sciences, Isfahan
City
Isfahan
Postal code
Approval date
2011-02-20, 1389/12/01
Ethics committee reference number
390622
Health conditions studied
1
Description of health condition studied
Pain of vaccines' injection
ICD-10 code
T78.9
ICD-10 code description
Adverse effect, unspecified
Primary outcomes
1
Description
Pain of vaccine injection
Timepoint
During injection
Method of measurement
Neonatal infant pain scale (NIPS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: breastfeeding
Category
Other
2
Description
Intervention group 2: massage therapy
Category
Other
3
Description
Intervention group 3: seed therapy
Category
Other
4
Description
Group 4: control
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Navab-Safavi Health Care Center
Full name of responsible person
Sanaz Sheykhi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Paiman Adibi
Street address
Hezarjerip Ave,Research vice chancelor, Isfahan University of Medical Sciences, Isfahan, Iran.
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 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
Isfahan University of Medical Sciences
Full name of responsible person
Mitra Savabi Isfahani
Position
Faculty member, Faculty of Nursing and Midwifery
Other areas of specialty/work
Street address
Hezaejirib Avenue.Isfahan University of Medical Sciences,Isfahan Isfahan,Iran.
City
Isfahan
Postal code
Phone
+98 31 1792 2936
Fax
Email
m_savabi@nm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zahra Abdeyazdan
Position
Associate Professor
Other areas of specialty/work
Street address
Hezarjerip Ave, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1792 2908
Fax
Email
Abdeyazdan@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mitra savabi Esfahani
Position
Academic member, Instructor
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 13117922936
Fax
Email
M_savabi@nm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)