ClinicalTrials.gg
CompletedNCT07388732Updated Feb 5, 2026

The Effect of Abdominal Massage on Jaundice and Defecation in Newborn Babies

An interventional study of Massage once a day for 3 days. and Massage twice a day for 3 days. in Hyper Bilirubinemia, Phototherapy and Jaundice, Neonatal, sponsored by Kutahya Health Sciences University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 10 Days. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 years 10 months after the study started (first participant enrolled Feb 2020, registered Jan 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
2 Days to 10 Days
Sex
All
01

Study 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).

02

Conditions studied

  • Hyper Bilirubinemia
  • Phototherapy
  • Jaundice, Neonatal

Keywords

  • Infant massage
  • Newborn
  • Phototherapy
  • Jaundice
  • Hyperbilirubinemia
  • Bilirubin
03

In context

Jaundice, Neonatal

110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.

This study's enrollment of 35 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.

Browse Jaundice, Neonatal studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Days to 10 Days
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Term newborns (37-42 weeks gestation)
  • 2-10 days postpartum
  • Diagnosed with hyperbilirubinemia
  • Receiving phototherapy
  • Fully orally fed.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Massage-1 Group

    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.

  • Experimental
    Massage-2 Group

    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.

  • No intervention
    Control Group

Interventions

  • OtherMassage once a day for 3 days.

    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.

  • OtherMassage twice a day for 3 days.

    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.

06

What researchers measure

Primary outcomes

  1. A transcutaneous bilirubin levels

    Time frame: 6 hours after phototherapy

  2. Defecation

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

07

Study locations

1 site
  • Kütahya Health Sciences University
    Kütahya, Province 43000, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Aug 2023, 41 months.

Of 35 non-industry interventional studies with no phase under Jaundice, Neonatal, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's 41 months is above that.

Counting every sponsor, half of 45 studies reached it within 11 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2026
First posted
Feb 5, 2026
StartActual
Feb 29, 2020
Primary completionActual
Aug 17, 2023
CompletionActual
Jan 14, 2025
Last update
Feb 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07388732
Responsible party
Sponsor
First posted
Feb 5, 2026
Start date
Feb 29, 2020
Primary completion
Aug 17, 2023
Completion
Jan 14, 2025
Last update
Feb 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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