Protocol summary

Summary
We have evaluated the effects of massage therapy on infants' response to phototherapy that were under treatment of hyperbilirubinemia. Enrolled infants were randomly divided into 2 groups: phototherapy alone (control/ no intervention group) and phototherapy + massage (case/ intervention group). The first baby referred was randomly determined to be enrolled in the control group, and the next infant was included in the case group. This process was repeated for each infant enrolled. Two phototherapy devices were randomly used in the case and control groups. Infants in the control group received traditional phototherapy and intensive care. Infants in the intervention group received massage in addition to conventional phototherapy and intensive care. Massage was performed thrice daily (every 8 h) for 30 min each. Before the massage, the hands of the researcher were warmed to the body temperature of the infant. Using gentle pressure, the researcher usually massaged different parts of the body with the soft parts of the fingers of both hands. Six organs of the body were massaged)lower limbs, upper limbs, abdomen, chest, back, and head and neck(.Patient data, including sex, birth weight, symptoms at presentation, duration of hospitalization, and treatment, were recorded by the pediatric resident or neonatal specialty doctor for each patient. A thorough examination of the newborn was done. Laboratory tests to determine the cause and severity of jaundice included to measure hematocrit, complete blood count, direct and indirect bilirubin, direct and indirect Coombs test, reticulocyte count, infant and maternal blood groups and Rh type).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201108077244N1
Registration date: 2016-05-16, 1395/02/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-16, 1395/02/27
Registrant information
Name
Hassan Boskabadi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 515 3987
Email address
boskabadih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2011-02-20, 1389/12/01
Expected recruitment end date
2013-02-21, 1391/12/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Massage on Response to Phototherapy in Newborns with Hyperbilirubinemia
Public title
Investigation of massage’s effect on phototropic answer in newborne jandice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: term infants (weight: 2500–4000 g) who required phototherapy for jaundice of unknown cause Exclusion Criteria: Infants with congenital anomalies؛5 minute Apgar score <7؛ contraindications for massage (sores, cuts, burns, infectious rashes, dislocations, hyperthermia, or swollen joints).
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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 Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences,Daneshgah St
City
Mashhad
Postal code
9138813944
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
88469

Health conditions studied

1

Description of health condition studied
neonatal hyperbilirubinemia
ICD-10 code
59.9
ICD-10 code description
Neonatal Jaundice

Primary outcomes

1

Description
Unknown hyperbilirubinemia
Timepoint
At admision
Method of measurement
Questionnaire, Laboratory Test

Secondary outcomes

1

Description
Bilirubine level
Timepoint
at admision, phototherapy, discharge time
Method of measurement
Diazo test

2

Description
Duration of phototherapy
Timepoint
Discharge time
Method of measurement
Hours

Intervention groups

1

Description
Infants in the control group received traditional phototherapy and intensive care.
Category
Treatment - Other

2

Description
Infants in the intervention group received massage in addition to conventional phototherapy and intensive care. Massage was performed thrice daily (every 8 h) for 30 min each. Using gentle pressure, the researcher usually massaged different parts of the body with the soft parts of the fingers of both hands. Six organs of the body were massaged) lower limbs, upper limbs, abdomen, chest, back, and head and neck (.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Hassan boskabad
Street address
Neonatal Unite, Ghaem Hospital, Ahmadabad ST.
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi, Vice chancellor for research
Street address
Vice chancellor for research، Mashhad University of Medical Sciences, Daneshgaj St
City
mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Najmeh Alfi
Position
resident of pediatrics
Other areas of specialty/work
Street address
Pediatrics Dep, Ghaem Hospital, Ahmadabad ST
City
mashhad
Postal code
Phone
+98 915 307 0641
Fax
Email
AlfiN881@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
hassan boskabadi
Position
associated professor, Neonatalogist
Other areas of specialty/work
Street address
Pediatrics Department, ghaem hospital, Ahmadabad ST.
City
mashhad
Postal code
9176699199
Phone
+98 51 3841 7451
Fax
+98 51 3841 7451
Email
boskabadih@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad Universty of medical science
Full name of responsible person
Hassan Boskabadi
Position
Asociated Professore, Neonatalogist
Other areas of specialty/work
Street address
Pediatrics Department, Ghaem Hospital, Ahmadabad ST.
City
Mashhad
Postal code
9176699199
Phone
+98 51 3841 7451
Fax
Email
Boskabadih@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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