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

Kafrelsheikh University90 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neonatal Jaundice

Interventions

Vimala massagePROCEDURE

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

HydrotherapyPROCEDURE

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

Eligibility

Sex: ALLMin age: 37 WeeksMax age: 42 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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

Time frame: 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

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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