The incidence of Hyperbilirubinemia as a physiological problem in nearly 80% of preterm infants occur during the first week of birth, and massage therapy is one of the most common CAM therapies in the world. This study aimed to examine the effects of massage on serum Bilirubin levels in preterm infants and the aforementioned population were all the preterm infants with a gestational age between 30 and 36 weeks of hospitalization with consider to the characteristics of participants of the study (Apgar score above 7, weighing more than 1250 g and stabilization of patient's condition) in the neonatal intensive care unit of Ghaem, Imam Reza and Omm-Albanin hospitals in Mashhad city. Billy test device, the demographic information and daily record questionnaires were data collection tools. In this clinical trial, 80 infants were selected by simple non-probability sampling and allocated into intervention and control groups. In the intervention group, massage was performed 2 times a day for 5 consecutive days with Field technique by researcher which the total time of massage was 15 minutes consisted of three 5-minutes phases; the routine care was carried out in the control one. Defecation frequency and the skin Bilirubin levels were measured and recorded before intervention and after that daily until tenth day after birth or discharge day in both groups. The neonates were excluded if they would catch neonatal clinical jundice or Icter treatment after 24 hours after birth, any proof of known causes of jaundice and suffering from infection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206059949N1
Registration date:2015-06-22, 1394/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Maryam Lotfi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
lotfim4@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University Of Medical Sciences
Expected recruitment start date
2012-10-28, 1391/08/07
Expected recruitment end date
2013-03-10, 1391/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bilirubin levels on preterm infants 30-36 weeks gestational age in massage and routine care groups
Public title
Effects of massage on bilirubin levels in preterm infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: stabilization of neonate's condition (12-24 hours after birth), Apgar score 7 or more, gestational age 30-36 weeks, weighing more than 1250 g, 5th minutes after birth Apgar score 7 or more, lack of any massage contraindication (like wound, skin lesions, burn, ecchymosis, fracture or joint dislocation, infectious rush and hyperthermia), lack of obvious congenital anomalies, absence of congenital infection
Exclusion criteria: getting neonatal clinical Icter after 24 hours after birth, any proof of known causes of jaundice like: Glucose-6-phosphate dehydrogenase deficiency, hypothyroidism, RH or ABO incompatibility or any evidence of erythrocytes lysis, getting phototherapy, blood transfusion and medication (drugs such as intravenous Immunoglobulin, Metalloporphyrins and Clofibrate) for jaundice a day after birth, Infection during the study (blood culture or cerebrospinal fluid culture - positive CSF).
Age
From 7 months old to 8 months 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
Ethics committee of Mashhad University of Medical Sciences
Street address
After Doktora Cross, Daneshgah Avenue, Taghi Abad Square
City
Mashhad
Postal code
345-91375
Approval date
2012-10-20, 1391/07/29
Ethics committee reference number
910140
Health conditions studied
1
Description of health condition studied
Neonatal jaundice, unspecified
ICD-10 code
P59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
skin bilirubin levels
Timepoint
Before the intervention, and then daily until the tenth day or discharged date
Method of measurement
in mg/dl with transcutaneous bilirubinometry
Secondary outcomes
1
Description
stool frequency
Timepoint
daily until the tenth day or discharged date
Method of measurement
Depending on the number recorded in the infants’ files
Intervention groups
1
Description
Intervention group : In the intervention group, the researcher will be massaged the infants twice a day on five consecutive days. Before the intervention, transcutaneous bilirubin levels are determined using a bilirubin analyzer. The researcher washes her hands thoroughly and warms and oils them, and will be massaged the infants with the soft parts of the fingers of both hands applying gentle pressure and using Field’s technique. The neonates massage will carry out in 15-minute sessions. 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 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.
Category
Other
2
Description
The control group: Infants in the control group will receive routine care and no intervention will be performed on them.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Maryam Lotfi
Street address
Ghaem Hospital, Ahmad Abad Boulevard, Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Maryam Lotfi
Street address
Imam Reza Square, Ebn-e Sina Avenue, Mashhad
City
Mashhad
3
Recruitment center
Name of recruitment center
Omm_Albanin Hospital
Full name of responsible person
Maryam Lotfi
Street address
Corner of Behjat 16, Ayatollah Behjat Avenue, Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
After Doktora Cross, Daneshgah Avenue, Taghi Abad Square
City
Mashhad
Grant name
گرانت پژوهشی سال 1391 خانم سهیلا کربندی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of 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
Soheila Karbandi
Position
Master
Other areas of specialty/work
Street address
Mashhad Nursing and Midwifery Faculty, Ebn-e Sina Avenue, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
karbandis@mums.ac.ir; nms.it@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
Hasan Boskabadi
Position
Neonatal specialist, associate professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmad Abad Boulevard, Mashhad
City
Mashhad
Postal code
9176699199
Phone
+98 51 3801 2592
Fax
+98 51 3845 3239
Email
BoskabadiH@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Lotfi
Position
Student of Master degree in Neonatal Intensive Care Nursing
Other areas of specialty/work
Street address
Mashhad Nursing and Mid wifery Faculty, Ebn-e Sina Avenue, Mashhad
City
Mashhad
Postal code
9137913199
Phone
+98 51 1859 1511
Fax
+98 51 1859 7313
Email
lotfim4@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)