The aim of this study was to compare the effects of massaging and rocking on the treatment of infantile colic. This randomized clinical trial involved 100 infants who were considered colic were randomly assigned to either infant massage (n=50) or rocking groups (n=50), Mothers in both groups trained the infant massage and rocking technique. Mothers were also asked to apply baby oil to prevent any damage to the skin of the infants and were asked to massage their infants for 15-20 minutes once during the day and once at night before sleeping for one week. In the rocking group, mothers were asked to embrace their children and rock them gently when the symptoms of colic appeared for 5-25 minutes.After recorded the number, duration and severity of cries and duration of sleep in a checklist within the seven days of intervention and register any side-effects during this period and two groups compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106054317N5
Registration date:2012-08-27, 1391/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-27, 1391/06/06
Registrant information
Name
Fatemeh Nahidi
Name of organization / entity
Shahid Beheshti University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 982188202512
Email address
nahidi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The researchers providing facilities and funding source to conduct this study.
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effects of massaging and rocking on infantile colic
Public title
The comparison of the effects of massaging and rocking on infantile colic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were infants who had Wessel’s factors or diagnosed with colic by the pediatrician; less than 12 weeks of age; with full-term birth; without any known diseases; who had not received any medical treatment for colic; who did not have any proven gastrointestinal diseases; who were not lactose intolerant and allergic to milk; whose mothers had not smoked during pregnancy and severe anxiety and infants who did not have any skin problems or any limitations for receiving massage.
The exclusion criteria were using traditional and medical treatment during the study and failure in conducting the intervention correctly.
Age
To 1 year 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
Used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The International&Virtual Branch of Shahid Beheshti University of Medical Sciences& Health Services
Street address
No 19, Shahid Abaspoor St, Next to Shahid Hemmat Bridge, Valiassr Ave,TEHRAN,IRAN
City
Tehran
Postal code
141553693
Approval date
2010-08-15, 1389/05/24
Ethics committee reference number
1769/116
Health conditions studied
1
Description of health condition studied
Infantile colic
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal painAbdominal tenderness NOS
Primary outcomes
1
Description
Treatment
Timepoint
Daily
Method of measurement
Information form
Secondary outcomes
1
Description
Side-effect
Timepoint
Daily
Method of measurement
Questionary
Intervention groups
1
Description
Massage.for 15-20 minutes once during the day and once at night before sleeping for one week.
Category
Treatment - Other
2
Description
Rocking :When the symptoms of colic appeared Mothers embraced their children and rock them gently for 5-25 minutes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The pediatric clinic of Amirkabir Hospital of Arak, Iran
Full name of responsible person
Fatemeh Nahidi faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery a
Street address
Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences& Health Services
Full name of responsible person
Mohamad Rahmati Roodsari
Street address
No 19, Shahid Abaspoor St, Next to Shahid Hemmat Bridge, Valiassr Ave,TEHRAN,IRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences& Health Services
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
The International&Virtual Branch of Shahid Beheshti University of Medical Sciences& Health Services
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery and student of P
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
1463718764
Phone
+98 21 2243 9912
Fax
+98 21 4421 8052
Email
nahidifateme@yahoo.com/f.nahidi87@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery and student of P
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
1463718764
Phone
+98 21 4421 8052
Fax
+98 21 4421 8052
Email
nahidifateme@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Beheshti University of Medical Sciences and Health Services
Full name of responsible person
Fatemeh Nahidi
Position
Faculty member of Shaheed Beheshti University of Medical Sciences ,MSc in Midwifery and student of P
Other areas of specialty/work
Street address
Women’s affairs Office, Shaheed Beheshti University of Medical Sciences and Health Services, Beside Taleghani Hospital, Evin, Tabnak St., Shaheed Chamran Avenue, Tehran, Iran
City
Tehran
Postal code
1463718764
Phone
+98 21 4421 8052
Fax
+98 21 4421 8052
Email
nahidifateme@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)