Protocol summary
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Study aim
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1) Determining the effect of massage on hyperbilirubinemia in newborns
2) Comparison of the average bilirubin on the first day in the control and intervention groups
3 Comparison of the average bilirubin on the second day in the control and intervention groups
4) Comparison of the average bilirubin on the third day in the control and intervention groups
5) Comparison of the average weight of hospitalized infants in the control and intervention groups
6) Comparing the stool frequency of infants in the control and intervention groups
7) Comparison of hospitalization time of infants in two control and intervention groups
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Design
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A clinical trial with a control group, double-blind, non-expert, randomized in pairs and odd
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Settings and conduct
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The location of the project of Tehran Bahrami Hospital
In this study, babies are divided into two groups, control and intervention. The control group is treated with phototherapy only for the treatment of hyperbilirubinemia. In the intervention group, massage is performed twice a day at certain times, 30 minutes after feeding for 15 minutes, once by the student and once by the mother for 3 days. In this study, 25 people are considered as the control group and 25 people as the intervention group. In these children, bilirubin, baby weight, frequency of urination and defecation and temperature are checked daily.
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Participants/Inclusion and exclusion criteria
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1) The weight of children should be between 2.5-4 kg
2) Pathological jaundice in these babies is more than 12mg/dl.
3) Gestational age more equal to 37 weeks
4) Babies more than 48 hours
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Intervention groups
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In the intervention group, massage is performed 2 times a day at specific times 30 minutes after breastfeeding for 15 minutes once by the student and once by the mother for 3 days.
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Main outcome variables
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bilirubin
stool frequency
Length of hospitalization
Weight
General information
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Reason for update
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Update in the start and end date of the expected and actual recruitment
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110420006243N4
Registration date:
2022-12-16, 1401/09/25
Registration timing:
prospective
Last update:
2024-10-28, 1403/08/07
Update count:
1
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Registration date
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2022-12-16, 1401/09/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-12-17, 1401/09/26
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Expected recruitment end date
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2023-02-20, 1401/12/01
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Actual recruitment start date
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2022-12-22, 1401/10/01
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Actual recruitment end date
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2023-02-20, 1401/12/01
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Trial completion date
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2023-02-24, 1401/12/05
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Scientific title
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effect of massage on neonatal hyperbilirubinemia
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Public title
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effect of massage on neonatal jaundice
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
hyperbilirubinemia more than 12 mg/dl
weight between 2/5-4 kg
gestational age more than 37
Exclusion criteria:
Babies less than 48 hours
A baby who is dehydration, does not feed well, is lethargic.
A baby with sepsis, seizures, hypoglycemia
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Age
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From 3 days old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Data analyser
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the control group, massage is performed without any purpose in addition to phototherapy, which made the participant unaware of the type of participation in the project. The massage is performed once by a doctor and once by the mother, which causes the researcher to be unaware. A data analyst also has no knowledge of the plan.
In the test group, targeted massage is performed with a special method in addition to phototherapy.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-08, 1400/12/17
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Ethics committee reference number
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IR.SHAHED.REC.1400.210
Health conditions studied
1
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Description of health condition studied
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hyperbilirubinemia
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ICD-10 code
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P59.9
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ICD-10 code description
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Neonatal jaundice, unspecified
Primary outcomes
1
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Description
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The amount of total bilirubin on different days
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Timepoint
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1) Measurement of bilirubin in the newborn's blood upon entering the study, then on the first, second, and third days after the intervention.
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Method of measurement
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by laboratory by photometric means using 2 and 4 dichloroaniline
Secondary outcomes
1
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Description
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Comparison of the average weight of hospitalized infants in the control and intervention groups
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Timepoint
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When the baby enters the plan and on the first, second and third days after the intervention
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Method of measurement
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by means of a digital scale and under the same conditions
2
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Description
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Comparison of infant stool frequency in the control and intervention groups
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Timepoint
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per day
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Method of measurement
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Number of diapers changed per day
3
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Description
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Comparison of hospitalization time of infants in two control and intervention groups
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Timepoint
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Record the number of days of hospitalization
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Method of measurement
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With the help of the date of arrival and departure
Intervention groups
1
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Description
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Intervention group :The intervention group is the group that, in addition to receiving phototherapy, received massage in this group. The massage is done with bare hands without any substance. The massage method is sub-designed: first the hands are washed and dried. The hands warm up the hands and bring them closer to the baby's body temperature. First, we start the massage from the face area and the thumb pad area around the eyes and cheeks with a very calm and low pressure, this work continues in the same way until the chest area. will continue. Then, the massage of the upper and lower limbs continues with a little more pressure than the previous areas. Finally, the baby's back is covered with the pads of the thumbs from the neck to the baby's buttocks. The massage method is the same for all the babies in the intervention group.
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Category
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Treatment - Other
2
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Description
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Control group: The control group in this study includes babies who only received phototherapy and no intervention was done for them
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahed University
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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After the design, the data is collected in an Excel file and archived after the publication of the article and analysis
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When the data will become available and for how long
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6 months after the project
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To whom data/document is available
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Pediatrician professors of universities
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Under which criteria data/document could be used
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The data can be used for university teaching or to validate the plan or meta-analysis for the research subject if the legal conditions of the person are met.
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From where data/document is obtainable
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To the mentioned address and the person responsible for the plan
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What processes are involved for a request to access data/document
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Writing a written letter and the reason for requesting the data after approval by the responsible person and with her decision
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Comments
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