This study is an investigation of the influence of massage on bilirubin in neonates with hyperbilirubinemia. In this quasi-experimental and two groups study, 80 neonates with physiological neonatal jaundice hospitalization at Ali Ebn Abi Talib hospital in Zahedan, were selected with available and sequential sampling and divided randomly in two groups, intervention group (40) and control group (40). Neonates were term, birth weight was between 2000- 4000 gr and had physiological jaundice and exited from study if they had congenital disorders, respiratory failure and infection. The tools were demographic questionnaire and Transcutaneous-Billirubinometry. In the intervention group, Tactile- Kinesthetic massage was implemented for 2 days and 3 times every days and every session lasted 10 to 15 minutes. The mean of bilirubin have been determined in pre intervention, 24 hours and 48 hours after intervention. The subjects in control group received routine care and no intervention performed on them. During study, the researcher recorded all information relating to infant include, skin and serum level of bilirubin and number of feedings per day. Reducing the bilirubin level, had considered as primary outcome in this study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050411261N2
Registration date:2015-06-11, 1394/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-11, 1394/03/21
Registrant information
Name
Alia Jalalodini
Name of organization / entity
Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 54 1244 2481
Email address
jalalodini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2013-11-23, 1392/09/02
Expected recruitment end date
2015-01-03, 1393/10/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Massage in Bilirubin in Term Neonatal with Hyperbilirubinemia in Care with Phototherapy Hospitalization in Neonatal Unit
Public title
The Effects of Massage in Bilirubin in Neonates with Jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Iranian; were normal birth weight and term; breast feeding; having no Exchange Transfusion
Exclusion criteria: Having congenital disorders; respiratory failure; infection and cephalohematoma; needing to Exchange Transfusion and severe diarrhea
Age
From 2 days old to 12 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Zahedan University of Medical Sciences and Health Services
Street address
Dr Hesaby Square, Janat Avenuse, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Postal code
0098
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
6025
Health conditions studied
1
Description of health condition studied
Neonatal physiological jaundice
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Indirect bilirubin
Timepoint
Pre intervention, 24 and 48 hours after intervention
Method of measurement
Transcutaneous-Billirubinometry
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, massage were implemented with tactile- kinesthetic massages. This method was implemented for 2 days and 3 times every days (9 AM, 3 PM and 7 PM) and every session lasted 10 to 15 minutes. The mean of bilirubin have been determined in pre intervention, 24 hours and 48 hours after latest massage (7 PM).
Category
Treatment - Other
2
Description
In control group, received routine cares and the mean of bilirubin have been determined in defined times.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Abne Abitaleb Hospital related to Zahedan University of Medical Sciences and Health Services
Full name of responsible person
Alieh Jalalodini
Street address
Dr Hesaby Square, Janat Avenuse, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Mahmudzadeh Sagheb
Street address
Dr Hesaby Square, Janat Avenuse, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
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 and Technology, Zahedan 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
Nursing and Midwifery College, Zahedan University of Medical Sciences
Full name of responsible person
Alia Alsadat Jalalodini
Position
Faculti member of science, Master of science in nursing,
Other areas of specialty/work
Street address
Mashahir Square, Nursing and Midwifery College, Zahedan
City
Zahedan
Postal code
9816743463
Phone
+98 54 3341 9406
Fax
Email
a_jalalodini@yaho.com jalalodini@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Nursing and Midwifery College
Full name of responsible person
Manighe Nourian
Position
Faculti member of science, Master of science in nursing, PhD student
Other areas of specialty/work
Street address
Kodakyar Avenuse, Evin Highway, Tehran
City
Tehran
Postal code
9985717443
Phone
+98 21 8820 2520
Fax
Email
ma.nourian@uswr.ac.ir manighea@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery College
Full name of responsible person
Alieh Jalalodini
Position
Faculti member of science, Master of science in nursing
Other areas of specialty/work
Street address
Mashahir Squre, Nursing and Midwifery College, Zahedan
City
Zahedan
Postal code
9816743463
Phone
+98 54 3341 9406
Fax
Email
a_jalalodini@yahoo.com jalalodini@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)