The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Primary Purpose
Hyperbilirubinemia, Neonatal
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Baby massage
Sponsored by
About this trial
This is an interventional supportive care trial for Hyperbilirubinemia, Neonatal focused on measuring infant, baby massage, hyperbilirubinemia, bilirubin
Eligibility Criteria
Inclusion Criteria:
- Born between 37-42 gestational weeks
- Birth weight between 2500-4000gr
- 1st and 5th Apgar score between 7-10
- Needing phototherapy treatment
- Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
- Orally fed
- No health problems other than indirect hyperbilirubinemia
- Newborns who has stable vital signs
Exclusion Criteria:
- ABO blood incompatibility or Rh incompatibility
- Diagnosed with direct hyperbilirubinemia
- Newborns who has skin anomaly
- Needing fluid replacement
- Newborns with gastrointestinal disorders
Sites / Locations
- Istanbul University Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Massage Group
Control Group
Arm Description
The incubator temperature was adjusted between 28-30 C, and it was administered while the baby was awake and one hour after feeding. Before the massage, the hands were washed and warmed. Just before each phototherapy application, 10-minute baby massage was performed by the researcher.Then phototherapy was applied.
Just received phototherapy twice a day
Outcomes
Primary Outcome Measures
Bilirubin levels
decreasing bilirubin levels within intervention times
Secondary Outcome Measures
Stool frequency
increasing stool frequency within intervention times
Full Information
NCT ID
NCT05356273
First Posted
April 25, 2022
Last Updated
September 26, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05356273
Brief Title
The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Official Title
The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Background: It has been reported in the current literature that massage has various positive physiological effects on the newborn. Also baby massage; It increases the collection and excretion of waste products such as bilirubin by accelerating the flow of blood, lymph and tissue fluids. Our aim is to investigate the effect of infant massage on hyperbilirubinemia in newborns receiving phototherapy.
Method: The population of the study consisted of babies who were hospitalized in Istanbul Haseki Training and Research Hospital Neonatal Intensive Care Unit between October 2021 and January 2022 and needed phototherapy. Transcutaneous bilirubin device and data collection form were used to obtain the data. 61 newborns who met the study criteria were randomly divided into experimental (n=30) and control (n=31) groups. Phototherapy was applied to all babies twice a day. In addition to phototherapy, infant massage was applied to the experimental group for 10 minutes just before the phototherapy. Bilirubin level measurements were made 2 hours after the end of phototherapy for both groups. Diaper changes for both groups were carried out 8 times a day, every 3 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal
Keywords
infant, baby massage, hyperbilirubinemia, bilirubin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Massage Group
Arm Type
Experimental
Arm Description
The incubator temperature was adjusted between 28-30 C, and it was administered while the baby was awake and one hour after feeding. Before the massage, the hands were washed and warmed. Just before each phototherapy application, 10-minute baby massage was performed by the researcher.Then phototherapy was applied.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Just received phototherapy twice a day
Intervention Type
Procedure
Intervention Name(s)
Baby massage
Intervention Description
Starting from the baby's face first, then the abdomen and chest, back, upper extremities and finally the lower extremities were massaged with semi-circular movements, respectively.
Primary Outcome Measure Information:
Title
Bilirubin levels
Description
decreasing bilirubin levels within intervention times
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Stool frequency
Description
increasing stool frequency within intervention times
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Born between 37-42 gestational weeks
Birth weight between 2500-4000gr
1st and 5th Apgar score between 7-10
Needing phototherapy treatment
Diagnosed with indirect hyperbilirubinemia 24 hours or more after birth
Orally fed
No health problems other than indirect hyperbilirubinemia
Newborns who has stable vital signs
Exclusion Criteria:
ABO blood incompatibility or Rh incompatibility
Diagnosed with direct hyperbilirubinemia
Newborns who has skin anomaly
Needing fluid replacement
Newborns with gastrointestinal disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Dogan
Organizational Affiliation
Researcher Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28179382
Citation
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Citation
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The Effect of Massage on the Bilirubin Level in Term Infants Receiving Phototherapy
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