CompletedNot Applicable

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

Turkey (Türkiye)35 participantsStarted 2020-02-29

Plain-language 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).

Who can participate

Age range

2 Days – 10 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

A transcutaneous bilirubin levels

Timeframe: 6 hours after phototherapy

Defecation

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

Trial details

NCT IDNCT07388732

SponsorKutahya Health Sciences University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-17

View on ClinicalTrials.gov More Hyper Bilirubinemia trials