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

A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia

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

Study Overview

• Status: Completed
• Conditions: Neonatal Jaundice
• Intervention / Treatment: Procedure: Vimala massage; Procedure: Hydrotherapy

Detailed Description

The researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. Neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. One subject for the control group, one for the study group (I), then the other for study group (II), and so on, distributed the participants into three equivalent groups as fellow:

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

Study Group (I): Consisted of 30 neonates who will receive Vimala massage. 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 (II): Consisted of 30 neonates who will receive hydrotherapy. It will be applied two times per day before feeding, each lasting 5-10 min.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr el-Sheikh
    • Kafr Ash Shaykh, Kafr el-Sheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.
Experimental: Study group I (Vimala group); Consisted of 30 neonates who will receive Vimala massage.	Procedure: Vimala massage; The massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift.
Active Comparator: Study group II (Hydrotherapy); Consisted of 30 neonates who will receive hydrotherapy.	Procedure: Hydrotherapy; Hydrotherapy will be applied two times per day before feeding, each lasting 5-10 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool	Clinical efficacy monitoring tool was developed by researchers after a review of relevant literature to assess the effectiveness of Vimala massage and Hydrotherapy in accelerating the regression time of jaundice.	through 5 days from admission

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice, Neonatal; Jaundice; Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
• Other Study ID Numbers: KafrelsheikhU3

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