Hyper BilirubinemiaNCT07388732
The Effect of Abdominal Massage on Jaundice and Defecation in Newborn Babies
A study testing Massage once a day for 3 days. and Massage twice a day for 3 days. in people with Hyper Bilirubinemia and Phototherapy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 days
- Conditions the study is for
- Hyper Bilirubinemia, Phototherapy, Jaundice, Neonatal
- What is being tested?
- Massage once a day for 3 days. and Massage twice a day for 3 days.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Feb 2020to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term newborns (37-42 weeks gestation)
- 2-10 days postpartum
- Diagnosed with hyperbilirubinemia
- Receiving phototherapy
- Fully orally fed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University
Kütahya, Province, 43000
About this study
Official title: Effects of Abdominal Massage Applied Once and Twice Daily in Phototherapy-Treated Term Newborns on Bilirubin Levels and Defecation: Randomized Controlled Trial
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).
- Conditions
- Hyper Bilirubinemia, Phototherapy, Jaundice, Neonatal
- Being tested
- Massage once a day for 3 days., Massage twice a day for 3 days.
- Keywords
- Infant massage, Newborn, Phototherapy, Jaundice, Hyperbilirubinemia, Bilirubin
- Medical subject headings
- Jaundice, Neonatal, Jaundice, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage once a day for 3 days.Other
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 twice a day for 3 days.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Massage-1 Group | Experimental | Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days. Receives: 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. Receives: Other: Massage twice a day for 3 days. |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
A transcutaneous bilirubin levels
Measured: 6 hours after phototherapy
Defecation
Measured: Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start29 Feb 2020
- Primary completion17 Aug 2023
- Study completion14 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyper BilirubinemiaStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388732
- Sponsor's protocol ID
- 2019/137
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Massage Applied Once and Twice Daily in Phototherapy-Treated Term Newborns on Bilirubin Levels and Defecation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07388732
- Acronym / sponsor ID
- 2019/137
- Conditions
- Hyper Bilirubinemia, Phototherapy, Jaundice, Neonatal
- Keywords
- Infant massage, Newborn, Phototherapy, Jaundice, Hyperbilirubinemia, Bilirubin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 29 Feb 2020 (actual)
- Primary completion
- 17 Aug 2023 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Massage-1 Group | Experimental | Other: Massage once a day for 3 days.Babies in Massage-1 received a 10-minute abdominal massage once a day before feeding for three days. |
| Massage-2 Group | Experimental | Other: Massage twice a day for 3 days.Babies in the Massage-2 group received a 10-minute abdominal massage twice a day before feeding for three days. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 2 to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Term newborns (37-42 weeks gestation)
- 2-10 days postpartum
- Diagnosed with hyperbilirubinemia
- Receiving phototherapy
- Fully orally fed.
Key exclusion criteria (7 listed)
- Newborns with ABO incompatibility or Rh incompatibility.
- Diagnosed with direct hyperbilirubinemia.
- Genetic/metabolic diseases
- Infections within 24 hours
- With a need for fluid replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage 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. | Other | Massage-1 Group |
| Massage 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. | Other | Massage-2 Group |
Primary outcome
A transcutaneous bilirubin levels
Time frame: 6 hours after phototherapy
Defecation
Time frame: Diapers were changed a total of 8 times a day. Defecation outcome was assessed in 24-hour intervals for 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Hyper Bilirubinemia
Active, not recruiting
Cycled Phototherapy
Hyper Bilirubinemia, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage once a day for 3 days. and Massage twice a day for 3 days. in people with Hyper Bilirubinemia and Phototherapy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A transcutaneous bilirubin levels (time frame: 6 hours after phototherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.