Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
Study NCT ID:
NCT06595368
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2024-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparing the Effect of Vimala Massage Versus Hydrotherapy on the Clinical Outcomes of Neonatal Hyperbilirubinemia
Sponsor:
Kafrelsheikh University
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial Comparing the Efficacy of Vimala Massage Versus Hydrotherapy on Clinical Outcomes in Neonatal Hyperbilirubinemia
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: