This study will be done with aim to compare the effectiveness of three Protecting methods of swaddling, abdominal and spinal massage on the infantile colic pain Referred to Alzahra Hospital in2017. This study is non blinded clinical trial. The research population includes all infants that will referred to Alzahra hospital in Isfahan. 100 infants will be selected in an available method and randomly assigned to three intervention groups and one control group. At the beginning of the study, the symptoms of symptoms of colic infants will be recorded by parents on the checklist daily. In the first group (swaddling method), the baby sturdy but in a comfortable position will be put in a blanket or linen cloth and the baby's legs will be fixed. Second group (abdominal massage), the infant in resting position receives abdominal massage in circular shape from the end of the chest 15 minutes and 2 times a day for 5 weeks. In the third group (massage of the spine), the infant lays on the abdomen,then the two sides of the spine from the neck to the hips receives massage for 15 minutes and 2 times a day for 5 weeks. The control group will not receive any interventions. At the end of the study, colic pain will be measured in each of the four groups and the groups will be compared.
Inclusion criteria: At least 1 week passed from the start of colicky pain; The absence of enterocolitis symptoms of.
Exclusion criteria: Performing other interventions or feed the infant with baby milk powder and cow milk during the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102514333N84
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Esfahan University of Medical Sciences
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effectiveness of three Protecting methods of Swaddling, abdominal and spinal massage on the infantile colic pain
Public title
The study on the effectiveness of three Protecting on the infantile colic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: At least 1 week passed from the start of colicky pain;
Breastfeeding for auxiliary, use of milk powder based on interviews with mother; Mother with diploma degree or higher; The absence of enterocolitis in infants based on medical records and their biographies; based on his medical records; Lack of infant congenital dislocation of the hip based on medical records; The absence of pyloric stenosis, according to the mother, and according to the diagnosis of neonatal physician; Mothers drug abuse during pregnancy based on interviews with mothers
Exclusion criteria: Performing other interventions or feed the infant with baby milk powder and cow milk during the study; If a week before interventions mother's have been trained in another location.
Age
From 14 days old to 3 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee Ethics, Esfahan University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
ir.mui.rec.1396.3.434
Health conditions studied
1
Description of health condition studied
Colic in infants
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
Primary outcomes
1
Description
Colic pain
Timepoint
Daily for 5 weeks
Method of measurement
Children's Pain Rating Scale (FLACC)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention first group (swaddling method), the baby sturdy but in a comfortable position will be put in a blanket or linen cloth and the baby's legs will be fixed.
Category
Other
2
Description
The second intervention group (abdominal massage), the infant in resting position receives abdominal massage in circular shape from the end of the chest 15 minutes and 2 times a day for 5 weeks
Category
Other
3
Description
The intervention third group (massage of the spine), the infant lays on the abdomen, then the two sides of the spine from the neck to the hips receives massage for 15 minutes and 2 times a day for 5 weeks
Category
Other
4
Description
The control group will not receive any interventions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Nastaran Esmaeilian Dehkordi
Street address
Shahid Keshari Highway, Sofah Boulevard
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Nematbakhsh
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
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, Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Nastaran Esmaeilian Dehkordi
Position
MA Student of nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
nastaranesmaeilian20@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammadi
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Vice Chancellor for Research Affairs, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 3060
Fax
Email
alimohammadi@nm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nastaran Esmaeilian Dehkordi
Position
MA Student of nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Esfahan University of Medical Sciences, hezarjarib street
City
Esfahan
Postal code
Phone
+98 31 3792 2906
Fax
Email
nastaranesmaeilian20@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)