Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy

Not Applicable

Completed

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Other: Gentle Body message; Other: Routine NICU Care

• Registration Number: NCT05260138
• Lead Sponsor: Alexandria University

Brief Summary

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.

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 Timeline

• Study Start: 2021-08-20
• Primary Completion: 2021-12-17
• Study Completion: 2021-12-18
• Status Verified: 2022-02
• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The intervention group	Gentle Body message	received all basic routine care in addition to regular position change and gentle body massage
The control group	Routine NICU Care	received the conventional NICU care

Primary Outcome Measures

Name	Time	Method
Bilirubin level	After 3 days	The researchers recorded the neonates' Bilirubin level from the laboratory results

Secondary Outcome Measures

Name	Time	Method
Percentage of the consumed milk	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
Length of hospital stay	After 10 days	the researchers obtained the neonates' length of hospital stay from admission to discharge
Frequency of stool	After 3 days	The researchers counted number of neonates' stool passage per day
daily weight	After 3 days	The researchers measured the neonates' weight daily using the same scale

Trial Locations

Locations (1)

Faculty of Nursing; 🇪🇬 Alexandria, Egypt