Comparing the Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia

NCT06595368 | Completed

• 1 other identifier: KafrelsheikhU3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of Vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (4)

• Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet

  Total serum bilirubin level monitoring sheet: it includes 2 tests of total serum bilirubin level \& indirect serum bilirubin tests. The daily measurement will be done, its primary purpose is to evaluate the effect of Vimala massage and hydrotherapy on newborns with Jaundice undergoing phototherapy. Bilirubin will be measured using microassay.

  Daily measurement from first day of neonate's admission to day 5 of admission

• Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet

  Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight

  Daily measurement from first day of neonate's admission to day 5 of admission

• Change from baseline of neonate's number of diaper exchange to monitor the frequency of defection and amount of stool on Bilirubin excretion monitoring sheet

  Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool

  Daily measurement from first day of neonate's admission to day 5 of admission

• Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet

  Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount

  Daily measurement from first day of neonate's admission to day 5 of admission

Secondary Outcomes (1)

• Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool

  through 5 days from admission

Study Arms (3)

Control Group

NO INTERVENTION

Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.

Study group I (Vimala group)

EXPERIMENTAL

Consisted of 30 neonates who will receive Vimala massage.

Procedure: Vimala massage

Study group II (Hydrotherapy)

ACTIVE COMPARATOR

Consisted of 30 neonates who will receive hydrotherapy.

Procedure: Hydrotherapy

Interventions

Vimala massage PROCEDURE

The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.

Study group I (Vimala group)

Hydrotherapy PROCEDURE

Hydrotherapy will be applied two times per day before feeding, each lasting 5-10 min.

Study group II (Hydrotherapy)

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute Apgar score of seven or above. Furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal

You may not qualify if:

• major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of pediatric nursing

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: July 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: January 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)