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effect of massage on neonatal hyperbilirubinemia

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History
# Registration date Revision Id
2 2023-03-30, 1402/01/10 318769
1 2022-12-16, 1401/09/25 249227
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  • Protocol summary

    The location of the project of Tehran Bahrami Hospital and Shahid Mustafa Khomeini 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, 20 people are considered as the control group and 20 people as the intervention group. In these children, bilirubin, baby weight, frequency of urination and defecation and temperature are checked daily.
    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.
    محل انجام طرح بیمارستان بهرامی تهران و بیمارستان شهید مصطفی خمینی در این مطالعه نوزاد به دو گروه شاهد و مداخله شده تقسیم میشوند. گروه شاهد فقط برای درمان هایپربیلیروبینمی تحت درمان فتوتراپی قرار میگیرند.در گروه مداخله ماساژ به صورت 2 بار روزانه در ساعاتی مشخص 30 دقیقه پس از شیرخوردن به مدت 15 دقیقه یکبار توسط دانشجو و یکبار توسط مادر به مدت 3 روز انجام میشود . در این مطالعه 20 نفر به عنوان گروه شاهد و 20 نفر به عنوان گروه مداخله شده مد نظر هستند. در این کودکان به صورت روزانه بیلی روبین،وزن نوزاد،دفعات ادرار و مدفوع و درجه حرارت چک میشود.
    محل انجام طرح بیمارستان بهرامی تهران در این مطالعه نوزاد به دو گروه شاهد و مداخله شده تقسیم میشوند. گروه شاهد فقط برای درمان هایپربیلیروبینمی تحت درمان فتوتراپی قرار میگیرند.در گروه مداخله ماساژ به صورت 2 بار روزانه در ساعاتی مشخص 30 دقیقه پس از شیرخوردن به مدت 15 دقیقه یکبار توسط دانشجو و یکبار توسط مادر به مدت 3 روز انجام میشود . در این مطالعه 25 نفر به عنوان گروه شاهد و 25 نفر به عنوان گروه مداخله شده مد نظر هستند. در این کودکان به صورت روزانه بیلی روبین،وزن نوزاد،دفعات ادرار و مدفوع و درجه حرارت چک میشود.

  • General information

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    50
    2022-12-07, 1401/09/16
    2022-12-17, 1401/09/26
    2022-12-15, 1401/09/24
    2023-02-20, 1401/12/01
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    2022-12-22, 1401/10/01
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    2023-02-20, 1401/12/01
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    2023-02-24, 1401/12/05
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    Update in the start and end date of the expected and actual recruitment
    empty
    تغییر در تاریخ پایان بیمارگیری مورد انتظار و تحقق یافته

  • Recruitment centers

    #1
    Name of recruitment center - English: Bahrami hospital , shahid Mostafa KHomeini hospital
    Name of recruitment center - Persian: بیمارستان بهرامی ،بیمارستان شهید مصطفی خمینی
    Full name of responsible person - English: Mohammadjavad Arabzadeh
    Full name of responsible person - Persian: محمدجواد عربزاده
    Street address - English: Shohada square ,Montazeri street, Memarian alley, block5, unit 5
    Street address - Persian: میدان شهدا،خیابان منتظری،بن بست معماریان،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 3379 3089
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:
    Name of recruitment center - English: Bahrami hospital
    Name of recruitment center - Persian: بیمارستان بهرامی
    Full name of responsible person - English: Mohammadjavad Arabzadeh
    Full name of responsible person - Persian: محمدجواد عربزاده
    Street address - English: Imam Hossein Square - Damavand St. - Shahid Kiyani St., Qasim Abad Station, Bahrami Children's Hospital
    Street address - Persian: میدان امام حسین-خیابان دماوند -خیابان شهید کیانی ایستگاه قاسم آباد بیمارستان فوق تخصصی کودکان بهرامی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 7301 3000
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:
    #2
    Name of recruitment center - English: shahid Mostafa KHomeini hospital
    Name of recruitment center - Persian: بیمارستان شهید مصطفی خمینی
    Full name of responsible person - English: Mohammadjavad Arabzadeh
    Full name of responsible person - Persian: محمدجواد عربزاده
    Street address - English: Valiasr Square, Keshavarz Blvd., Palestine St., Italy St., plate 9
    Street address - Persian: ميدان وليعصر ، بلوار كشاورز ، خيابان فلسطين ، خيابان ايتاليا ، پلاك 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1416643491
    Phone: +98 21 8896 6130
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: The university of Shahed
    Name of organization / entity - Persian: دانشکده پزشکی دانشگاه شاهد
    Full name of responsible person - English: Mohammadjavad Arabzadeh
    Full name of responsible person - Persian: محمدجواد عربزاده
    Street address - English: Block 5, unit 5, Shahada Square, Montazeri Street, Memarian Block
    Street address - Persian: میدان شهدا،خیابان منتظری،بن بست معماریان،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 3379 3089
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Afshin Magd
    Full name of responsible person - Persian: افشین مجد
    Street address - English: Valiasr Square, Keshavarz Blvd., Palestine St., Italy St., plate 9
    Street address - Persian: ميدان وليعصر ، بلوار كشاورز ، خيابان فلسطين ، خيابان ايتاليا ، پلاك 9
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1416643491
    Phone: +98 21 8896 6130
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ُShahada Square, Montazeri St., Block 5, Unit 5
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک 5واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 3379 3089
    Mobile: +98 912 387 9087
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ُShahada Square, Montazeri St., Block 5, Unit 5
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک 5واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 8896 9437
    Mobile: +98 912 387 9087
    Fax:
    Email: dr.shrafati@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 5, Plate 5, Montazeri Street, Shahada Square
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 3379 3989
    Mobile: +98 912 387 9087
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 5, Plate 5, Montazeri Street, Shahada Square
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 8896 9437
    Mobile: +98 912 387 9087
    Fax:
    Email: dr.shrafati@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: professor assistant
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 5, Plate 5, Montazeri Street, Shahada Square
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 3379 3089
    Mobile: +98 912 387 9087
    Fax:
    Email: mohammadjavad.arabzadeh123@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shiva Rafati
    Full name of responsible person - Persian: شیوا رفعتی
    Position - English: professor assistant
    Position - Persian: استادیار
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Unit 5, Plate 5, Montazeri Street, Shahada Square
    Street address - Persian: میدان شهدا،خیابان منتظری،پلاک5،واحد5
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1714716653
    Phone: +98 21 8896 9437
    Mobile: +98 912 387 9087
    Fax:
    Email: dr.shrafati@yahoo.com
    Web page address:

Protocol summary

Study aim
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
Design
A clinical trial with a control group, double-blind, non-expert, randomized in pairs and odd
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
bilirubin stool frequency Length of hospitalization Weight

General information

Reason for update
Update in the start and end date of the expected and actual recruitment
Acronym
IRCT registration information
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
Registration date
2022-12-16, 1401/09/25
Registrant information
Name
Shiva Rafati
Name of organization / entity
Shahed university
Country
Iran (Islamic Republic of)
Phone
+98 21 8896 9437
Email address
rafati@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-17, 1401/09/26
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
2022-12-22, 1401/10/01
Actual recruitment end date
2023-02-20, 1401/12/01
Trial completion date
2023-02-24, 1401/12/05
Scientific title
effect of massage on neonatal hyperbilirubinemia
Public title
effect of massage on neonatal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of shahed university of medical sciences
Street address
Tehran, Shahid Montazeri Street, Memarian Block, Block 5, Unit 5
City
tehran
Province
Tehran
Postal code
1714716653
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.SHAHED.REC.1400.210

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
The amount of total bilirubin on different days
Timepoint
1) Measurement of bilirubin in the newborn's blood upon entering the study, then on the first, second, and third days after the intervention.
Method of measurement
by laboratory by photometric means using 2 and 4 dichloroaniline

Secondary outcomes

1

Description
Comparison of the average weight of hospitalized infants in the control and intervention groups
Timepoint
When the baby enters the plan and on the first, second and third days after the intervention
Method of measurement
by means of a digital scale and under the same conditions

2

Description
Comparison of infant stool frequency in the control and intervention groups
Timepoint
per day
Method of measurement
Number of diapers changed per day

3

Description
Comparison of hospitalization time of infants in two control and intervention groups
Timepoint
Record the number of days of hospitalization
Method of measurement
With the help of the date of arrival and departure

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
Control group: The control group in this study includes babies who only received phototherapy and no intervention was done for them
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahrami hospital
Full name of responsible person
Mohammadjavad Arabzadeh
Street address
Imam Hossein Square - Damavand St. - Shahid Kiyani St., Qasim Abad Station, Bahrami Children's Hospital
City
Tehran
Province
Tehran
Postal code
1714716653
Phone
+98 21 7301 3000
Email
mohammadjavad.arabzadeh123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Afshin Magd
Street address
Valiasr Square, Keshavarz Blvd., Palestine St., Italy St., plate 9
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 6130
Email
mohammadjavad.arabzadeh123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
10
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
Shahed University
Full name of responsible person
Shiva Rafati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
ُShahada Square, Montazeri St., Block 5, Unit 5
City
Tehran
Province
Tehran
Postal code
1714716653
Phone
+98 21 8896 9437
Email
dr.shrafati@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Shiva Rafati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 5, Plate 5, Montazeri Street, Shahada Square
City
Tehran
Province
Tehran
Postal code
1714716653
Phone
+98 21 8896 9437
Email
dr.shrafati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Shiva Rafati
Position
professor assistant
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Unit 5, Plate 5, Montazeri Street, Shahada Square
City
Tehran
Province
Tehran
Postal code
1714716653
Phone
+98 21 8896 9437
Email
dr.shrafati@yahoo.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
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After the design, the data is collected in an Excel file and archived after the publication of the article and analysis
When the data will become available and for how long
6 months after the project
To whom data/document is available
Pediatrician professors of universities
Under which criteria data/document could be used
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.
From where data/document is obtainable
To the mentioned address and the person responsible for the plan
What processes are involved for a request to access data/document
Writing a written letter and the reason for requesting the data after approval by the responsible person and with her decision
Comments
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