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

Not Applicable

Recruiting

• Conditions: Neonatal Jaundice
• Interventions: Procedure: Vimala massage; Procedure: Hydrotherapy

• Registration Number: NCT06595368
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

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 Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group I (Vimala group)	Vimala massage	Consisted of 30 neonates who will receive Vimala massage.
Study group II (Hydrotherapy)	Hydrotherapy	Consisted of 30 neonates who will receive hydrotherapy.

Primary Outcome Measures

Name	Time	Method
Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet	Daily measurement from first day of neonate's admission to day 5 of admission	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.
Change from baseline of neonate's weight on Bilirubin excretion monitoring sheet	Daily measurement from first day of neonate's admission to day 5 of admission	Bilirubin excretion monitoring sheet: it includes daily measurement of the neonate's weight
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	Daily measurement from first day of neonate's admission to day 5 of admission	Bilirubin excretion monitoring sheet: it includes daily monitoring of infant's diaper exchange to monitor the frequency of defection and amount of stool
Change from baseline of neonate's total feeding amount on Bilirubin excretion monitoring sheet	Daily measurement from first day of neonate's admission to day 5 of admission	Bilirubin excretion monitoring sheet: it includes daily monitoring of neonate's total feeding amount

Secondary Outcome Measures

Name	Time	Method
Estimate the time of jaundice regression and duration of phototherapy on Clinical efficacy monitoring tool	through 5 days from admission	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.

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafr el-Sheikh, Egypt