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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
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hyperbilirubinemia, Neonatal focused on measuring infant, baby massage, hyperbilirubinemia, bilirubin

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

First Posted
April 25, 2022
Last Updated
September 26, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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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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