NCT07388732

Brief Summary

Hyperbilirubinemia is a common condition in term newborns and is often treated with phototherapy. It is thought that abdominal massage may increase bowel movements, thereby increasing the frequency of defecation and supporting bilirubin excretion. This randomized controlled trial aimed to evaluate the effect of abdominal massage, applied once or twice daily using the Vimala technique, on transcutaneous bilirubin levels and defecation frequency in hyperbilirubinemia-affected term newborns receiving phototherapy in the neonatal intensive care unit. The study was conducted in the neonatal intensive care unit of a university hospital between February 29, 2020, and August 17, 2023. A total of 35 newborns meeting the inclusion criteria were randomly divided into three groups. Group Massage-1 received 10 minutes of abdominal massage once daily before feeding for three days (n=12). Group Massage-2 received massage twice daily for the same duration (n=10). The control group received routine care (n=13).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 29, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

January 28, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

Infant massageNewbornPhototherapyJaundiceHyperbilirubinemiaBilirubin

Outcome Measures

Primary Outcomes (2)

  • A transcutaneous bilirubin levels

    6 hours after phototherapy

  • Defecation

    Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.

Study Arms (3)

Massage-1 Group

EXPERIMENTAL

Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days.

Other: Massage once a day for 3 days.

Massage-2 Group

EXPERIMENTAL

Babies in the Massage-2 group received a 10-minute abdominal massage twice a day before feeding for three days.

Other: Massage twice a day for 3 days.

Control Group

NO INTERVENTION

Interventions

The Vimala Massage Application, before massaging, hands were washed and lubricated. The massage began with a patting motion on the newborn's abdomen, followed by clockwise circular movements and semicircles. The massage was then performed in the shapes of an I, inverted L, and U along the abdomen. Finally, a walking movement was performed with the fingertips from the right to the left side of the abdomen. Each movement was repeated six times.

Massage-1 Group

The Vimala Massage Application, before massaging, hands were washed and lubricated. The massage began with a patting motion on the newborn's abdomen, followed by clockwise circular movements and semicircles. The massage was then performed in the shapes of an I, inverted L, and U along the abdomen. Finally, a walking movement was performed with the fingertips from the right to the left side of the abdomen. Each movement was repeated six times.

Massage-2 Group

Eligibility Criteria

Age2 Days - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Term newborns (37-42 weeks gestation)
  • days postpartum
  • Diagnosed with hyperbilirubinemia
  • Receiving phototherapy
  • Fully orally fed.

You may not qualify if:

  • Newborns with ABO incompatibility or Rh incompatibility.
  • Diagnosed with direct hyperbilirubinemia.
  • Genetic/metabolic diseases
  • Infections within 24 hours
  • With a need for fluid replacement
  • Having skin anomalies
  • Having abdominal disorders and surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kütahya Health Sciences University

Kütahya, Province, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Jaundice, NeonatalJaundiceHyperbilirubinemia

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Newborns meeting the sampling criteria were assigned to experimental and control groups using a simple random number table. The study was single-blind because the researchers knew which group the newborns in the sample were in. However, the statistical analysis was double-blind because the statistics for the data were performed by a different person.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

February 29, 2020

Primary Completion

August 17, 2023

Study Completion

January 14, 2025

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations