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

Kafrelsheikh University

Status: Enrolling

Conditions: Neonatal Jaundice

Treatments: Procedure: Hydrotherapy; Procedure: Vimala massage

Study type: Interventional

Funder types: Other

Identifiers

NCT06595368

KafrelsheikhU3

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control Group

No Intervention group

Description:

Consisted of 30 newborns who will receive conventional hospital care with no additional interventions.

Study group I (Vimala group)

Experimental group

Description:

Consisted of 30 neonates who will receive Vimala massage.

Treatment:

Procedure: Vimala massage

Study group II (Hydrotherapy)

Active Comparator group

Description:

Consisted of 30 neonates who will receive hydrotherapy.

Treatment:

Procedure: Hydrotherapy