Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy

February 18, 2022 updated by: Zohour Ibrahim Mahmoud Rashwan, Alexandria University

Effect of Massaging on Bilirubin Level Among Full Term Neonates With Hyperbilirubinemia Under Phototherapy.

This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy.

Hypothesis

Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were randomly assigned to two equal groups.

The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.

The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 56321
        • Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Full-term
  • receive enteral feeding (breast, bottle, or mixed feeding, gavage)
  • Newly admitted

Exclusion Criteria:

  • Required exchange transfusion
  • Required mechanical ventilation
  • Has acute phase of circulatory insufficiency
  • Hemolytic disease
  • Neurological disorders
  • Congenital anomalies
  • Neonatal sepsis Diarrhea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The intervention group
received all basic routine care in addition to regular position change and gentle body massage
Other: Gentle Body message
The intervention group received gentle body massage twice/day and position change from supine to lateral every two hours under the phototherapy for three consecutive days in addition to routine NICU care.
ACTIVE_COMPARATOR: The control group
received the conventional NICU care
Other: Routine NICU Care
received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilirubin level
Time Frame: After 3 days
The researchers recorded the neonates' Bilirubin level from the laboratory results
After 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of the consumed milk
Time Frame: After 3 days
The researchers calculated the percentage of the consumed milk by dividing the actual amount sucked by the neonate on the prescribed amount and multiplied by 100
After 3 days
Frequency of stool
Time Frame: After 3 days
The researchers counted number of neonates' stool passage per day
After 3 days
daily weight
Time Frame: After 3 days
The researchers measured the neonates' weight daily using the same scale
After 3 days
Length of hospital stay
Time Frame: After 10 days
the researchers obtained the neonates' length of hospital stay from admission to discharge
After 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 20, 2021

Primary Completion (ACTUAL)

December 17, 2021

Study Completion (ACTUAL)

December 18, 2021

Study Registration Dates

First Submitted

February 18, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170301221

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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