Aim: studying the effect of massage on serum bilirubin levels in term infants with hyperbilirubinemia.
This clinical trial research will be carry out on full-term infants with hyperbilirubinemia at the "22 Bahman Hospital" in Gonabad, Iran. The infants hospitalized with hyperbilirubinemia will be randomly assigned into a massage group and a control group. The intervention consist of massage and passive movements carried out on the infants of the massage group in 15-minute, in 3 consecutive hours, daily for 4 days (inclusive of phototherapy treatment). The mean bilirubin levels were then monitored and compared with those of the control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811043150N1
Registration date:2011-05-09, 1390/02/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-09, 1390/02/19
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
2009-05-31, 1388/03/10
Expected recruitment end date
2010-05-31, 1389/03/10
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 Term Neonates ffected with Hyperbilirubinemia
Public title
The Effect of Massage on Serum Bilirubin Levels in Term Neonates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: term neonates born after 37-42 weeks of pregnancy; weighing between 2500gm and 4000gm; having a bilirubin level of 13–24mg/dl; All the children were breast fed; were not under any medication and showed no contra-indications to massage. Exclusion criteria: having jaundice on the 1st day of birth; hyper bilirubinemia caused by hemolysis; diseases or infections occurring in the course of the study; blood transfusion carried out in the infant; the occurrence of bronze children's syndrome during phototherapy; diarrhea during phototherapy; and lastly the desire of the parents to be omitted from the study.
Age
From 2 years old to 7 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
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
Ethics Committee of Gonabad univercity of medical sciences
Street address
Vice chancellor for research, Gonabad university of medical sciences, Next to the Asian Road
City
Gonabad
Postal code
9691793718
Approval date
2010-04-21, 1389/02/01
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
Level of Serum Bilirubin
Timepoint
Daily
Method of measurement
Blood test
Secondary outcomes
1
Description
Jaundice
Timepoint
End study
Method of measurement
Clinical Sign
Intervention groups
1
Description
intervention groups: tactile and kinesthetic stimulation will carry out by the mother under the supervision of the researcher in 15-minute sessions in 3 consecutive hours, daily for 4 days. Each session consisted of 3 standardized phases of 5 minutes each, in which the infants were keep in a prone position in the 1st and 3rd phase. The neonates will gently stroke with the soft, smooth surfaces of all the fingers of both hands. The tactile stimulation procedure included 12 strokes at a rate of approximately 5 seconds per stroking motion over each region of the neonate in the following sequence: • From the top of the head down the sides of the face to the neck, and vice versa • From the back of the neck to both ends of the shoulders, and vice versa • From the thighs down to the ankles, and vice versa • From the shoulders down the arms to the wrist, and vice versa In the middle phase, the neonate will make to lie in a supine position for kinesthetic stimulation that included 5 segments of 1 minute each which consist of 6 passive flexion/extension movements, each lasting 10sec. The stimulation will do on each arm, then each leg and lastly both legs together. The neonate will then return to a prone position to repeat the tactile stimulation phase. Massage intervention will carry out alongside phototherapy (without interruption) in the sample group at a fix hour between 7am and 7pm every day. Initially, phototherapy lamps will check and adjust at a height of 30cm above the neonates who weill keep in the cots with eyes close and reproductory organs will protect. After every 2 hours of therapy a rest period of 30min. will give in which the neonates will allow to breast feed with eyes open. Bilirubin will measure at 6a.m. everydaycontrol group: without intervention.
Category
Treatment - Other
2
Description
control group will administer routine ward care.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad University of Medical Sciences
Full name of responsible person
Mahdi Basiri Moqadam
Street address
Next to the Asian Road
City
Gonabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, 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
Vice chancellor for research, 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 Moqadam
Position
Master of Science, in Nursing Education, Faculty Member
Other areas of specialty/work
Street address
Next to the Asian Road, Deputy for Research, Gonabad University of Medical Sciences and Health Services, Gonabad, Iran
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
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
Next to the Asian Road, Vice chancellor for research, Gonabad University of Medical Sciences and Health Services
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
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
Next to the Asian Road, Vice chancellor for research, Gonabad University of Medical Sciences and Health Services
City
Gonabad
Postal code
9691793718
Phone
+98 53 3733 2629
Fax
+98 53 3722 3814
Email
basiri1344@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)