Comparison of three methods of foot massage, kangaroo care and standard care on bilirubin level and physiological indicators of term neonates with physiological jaundice
Comparison of three care methods on the bilirubin level of full-term infants with physiological jaundice
Design
The clinical trial consisted of two intervention groups, one control group, parallel group trial, single -blind and randomized on 84 term neonates with physiological jaundice. infants are assigned to groups based on a randomization sequence that will be generated in advance, which is unpredictable. To assign samples to 3 groups, the block randomization method with random number generator software will be used. This will be done with software called Sealed Envelope.
Settings and conduct
This study will be performed in Shohada Hospital in Qom. After the phototherapy of each of the three groups, their bilirubin levels are measured and recorded, then SPSS version 22 software is used to interpret the data and the variables are interpreted. Only data analyzers will not know how the samples are placed in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no underlying, congenital and infectious diseases; term infants; birth weight over 2,500 grams; exclusive breastfeeding.
Exclusion criteria: Infant parents' unwillingness to participate in the study; The presence of problems in the soles of the feet
Intervention groups
First intervention group: Babies is placed on the bed lying on his back, and researcher holds the baby's heel and massages the relevant area in a controlled manner. Second intervention group: In kangaroo care group babies with the KMC method, the mother with kangaroo care clothes is placed in a semi-sitting position, and the naked baby will be placed between the mother's breasts. Control group: In this group there is no intervention.
Main outcome variables
bilirubin level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051142N3
Registration date:2022-08-02, 1401/05/11
Registration timing:prospective
Last update:2022-08-02, 1401/05/11
Update count:0
Registration date
2022-08-02, 1401/05/11
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2023-01-30, 1401/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of foot massage, kangaroo care and standard care on bilirubin level and physiological indicators of term neonates with physiological jaundice
Public title
Comparison of three methods of foot massage, kangaroo care and standard care on bilirubin level and physiological indicators
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No underlying, congenital and infectious disease
Term infants (gestational age equal to or greater than 37 weeks)
Birth weight over 2,500 grams
Exclusive breastfeeding
Exclusion criteria:
Infant parents' unwillingness to participate in the study
The presence of problems in the soles of the feet (edema, tissue damage, skin infection, skin rashes, fractures)
Need for blood transfusion
Age
From 1 day old to 21 days old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Infants are assigned to two intervention groups and one control group based on the randomization sequence that will be generated in advance, which is unpredictable and its arrangement is completely random. To allocate the samples, the block randomization method with the size of 3 blocks will be used, so that by using the software for generating random numbers in the block method, a randomization sequence will be generated according to the sample size required for the three groups. First, all the modes in which the 3 letters A, B and C can be put together in blocks of 3 are generated, then a block is randomly selected by placing it among the blocks and the layout pattern in that block will be used to allocate infants. Finally this block will be placed in the main container and another block will be selected again. Blocks of 3 will all be in the same container. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak university of medical sciences
Street address
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2022-07-02, 1401/04/11
Ethics committee reference number
IR.ARAKMU.REC.1401.077
Health conditions studied
1
Description of health condition studied
Physiological jaundice
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bilirubin level
Timepoint
Every 24 hours
Method of measurement
The baby's bilirubin is taken by capillary inside the capillary tube and sent to the hospital laboratory and measured by photometric method according to the routine of the newborn department and is continuously collected and recorded in the form.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Babies in the reflexology group receive massage in the respective specific area, in such a way that the baby is placed on the bed in a quiet and bright room lying on his back and completely relaxed, and the researcher washes his hands to prevent infection and after Warming up, first apply olive oil from Ladan Talai company made in Iran to reduce friction and then test the olive oil on the child's forearm (in order to rule out a possible allergy to olive oil) and start massaging the specific area. researcher holds the baby's heel with his left hand and massages the relevant area with his right thumb in a controlled and dedicated manner. The frequency of massage for each baby for the reflexology intervention group will be once a day for 15 minutes (30 minutes in total for both legs of the baby).
Category
Other
2
Description
Intervention group2: In the babies of the kangaroo care group by the KMC method, the mother with the kangaroo care clothes is placed on the folding bed in a semi-sitting position (40-60 degrees) or lying down and the naked baby , wearing only a diaper and a hat, will be placed between the mother's breasts with the help of a nurse. This KMC method will last for 30 minutes, so that it will be done at least five times a day (every 3 hours) in the morning, evening and night shifts during breastfeeding.
Category
Other
3
Description
Control group: Like the two intervention groups, they are treated with phototherapy. In this group there is no intervention (reflexology, KMC).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Mahbobeh Sajadi
Street address
Tohid boulevard, Northern Hekmat Ave, Qom city, Iran
City
Qom
Province
Ghoum
Postal code
3819693345
Phone
+98 25 3110 0000
Email
golmehrsherafati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3493 4634
Email
golmehrsherafati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
University complex of the Great Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098 86341735057
Email
golmehrsherafati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
since the winter of 2023
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
Control of bilirubin level and physiological indicators of full-term infants with physiological jaundice
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences