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

NCT ID: NCT06595368

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-01-30

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.

Conditions

Neonatal Jaundice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group I (Vimala group)

Consisted of 30 neonates who will receive Vimala massage.

Group Type: EXPERIMENTAL

Vimala massage

Intervention Type: 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.

Study group II (Hydrotherapy)

Consisted of 30 neonates who will receive hydrotherapy.

Group Type: ACTIVE_COMPARATOR

Hydrotherapy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

Hydrotherapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 37 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Eman Wardany Abdelaal Mohamed

assistant professor of pediatric nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt

Countries

Egypt

Other Identifiers

KafrelsheikhU3

Identifier Type: -

Identifier Source: org_study_id