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Completed

NCT Number: NCT06595368

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

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

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Key information

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

hydrotherapy

Procedure

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

Primary outcomes

  1. Change from baseline of Total serum bilirubin level on Total serum bilirubin level monitoring sheet

    Time frame: 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.

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

    Time frame: 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

  3. 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

    Time frame: 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

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

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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