Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt
NCT Number: NCT06595368
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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Notify Me37 week–42 week
All sexes
Interventional
Not applicable
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33516, Egypt
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.
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
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 will be applied two times per day before feeding, each lasting 5-10 min.
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.
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
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
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
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.
Kafrelsheikh University
Other
A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia
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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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