Aim: To determine the effect of massage on serum bilirubin levels in preterm neonates affected with hyperbilirubinemia. Infants admitted to Hashemi-Nejad hospital who have inclusion criteria, will be divided into two categories based on gestational age: 32-34 and 35-37 weeks. Then they will randomly be assigned to control and massage groups. Neonates of control group will receive routine ward care and neonates of treatment group will receive massage intervention. The intervention consists of massage 20 minutes, twice daily, for 4 days. Massage will be done one hour after the morning feeding and one hour after noon feeding. Massage starting on the face, mothers use two thumbs gently rubbing the preorbital and cheek regions; and then moving on the chest, two hands of performer from the lower margin of chest slide to opposite upper edge alternately; then to the abdomen, corresponding to the conformation of colon, the performer push a half circle gently, next is on the limbs, the performer use hand by hand with moderate pressure external side of the upper and lower limbs; and finally the back, the performer slide two hand from vertebra to two sides by neck to buttock.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111013150N2
Registration date:2012-08-21, 1391/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-21, 1391/05/31
Registrant information
Name
Mahdi Basiri Moghadam
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3722 3028
Email address
basiri1344@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Gonabad university of medical sciences
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Massage on Serum Bilirubin Levels in Preterm Neonates affected with Hyperbilirubinemia
Public title
The Effect of Massage on Serum Bilirubin Levels in Preterm Neonates affected with Hyperbilirubinemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Parental satisfaction to participate their child in the study; Absence of jaundice in the first day; gestational age < 37 weeks; being breastfed; Absence of infection and any disease during the study. Exclusion criteria: the desire of the parents to be omitted from the study; diseases or infections occurring in the course of the study; Discharge before completing the treatment period; Treatment be started with phototherapy.
Age
To 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Gonabad university of medical sciences
Street address
Vice chancellor for research, Gonabad university of medical sciences, Next to the Asian Road
City
Gonabad
Postal code
96915
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
90/4
Health conditions studied
1
Description of health condition studied
Hyperbilirubinemia
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
bilirubin level
Timepoint
daily
Method of measurement
transcutaneous bilirubin test
Secondary outcomes
1
Description
Jaundice
Timepoint
End of the study
Method of measurement
Clinical Signs
Intervention groups
1
Description
Neonates of control group will receive routine ward care.
Category
N/A
2
Description
Neonates of treatment group will receive massage intervention. The intervention consists of massage 20 minutes, twice daily, for 4 days. Massage will be done one hour after the morning feeding and one hour after noon feeding. Massage starting on the face, mothers use two thumbs gently rubbing the preorbital and cheek regions; and then moving on the chest, two hands of performer from the lower margin of chest slide to opposite upper edge alternately; then to the abdomen, corresponding to the conformation of colon, the performer push a half circle gently, next is on the limbs, the performer use hand by hand with moderate pressure external side of the upper and lower limbs; and finally the back, the performer slide two hand from vertebra to two sides by neck to buttock.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashemi-Nejad Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Ali Ekrami
Street address
Next to the Asian Road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri Moghadam
Position
Master of Science, in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Deputy for Research, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
96915
Phone
+98 53 3722 3028
Fax
Email
Basiri1344@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri Moqadam
Position
Master of Science in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Deputy for Research, Gonabad University of Medical Sciences, Next to the Asin Road
City
Gonabad
Postal code
96915
Phone
+98 53 3722 3028
Fax
Email
Basiri1344@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri Moqadam
Position
Master of Science in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Deputy for Research, Gonabad University of Medical Sciences, Next to the Asian Road
City
Gonabad
Postal code
96915
Phone
+98 53 3722 3028
Fax
Email
Basiri1344@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)