Hyperbilirubinemia, NeonatalNCT06630689
Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort
A study testing Dry Full Body Massage and Oil Full Body Massage in people with Hyperbilirubinemia, Neonatal, run by meral güven at 1 site in Turkey (Türkiye).
Trial summary
The need for infant massage may come to the forefront as a part of routine care in the neonatal intensive care unit to reduce high bilirubin levels in newborns and to reduce the need for phototherapy treatment. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Hyperbilirubinemia, Neonatal
- What is being tested?
- Dry Full Body Massage and Oil Full Body Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 31 Aug 2024
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being a term (37-42 weeks) newborn.
- The newborn's postnatal age is between 1st and 28th days
- The 1st and 5th Apgar score is between 7-10
- The newborn is fed orally
- The newborn's birth weight is 2500 grams and above
- Phototherapy treatment is terminated and followed up
Show all 10Show fewer
- Receiving nutritional support for hyperbilirubinemia
- No health problems other than hyperbilirubinemia
- Stable general health status
- Parents' willingness and volunteering to participate in the study constitute the inclusion criteria for the study.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The need for infant massage may come to the forefront as a part of routine care in the neonatal intensive care unit to reduce high bilirubin levels in newborns and to reduce the need for phototherapy treatment. This study was planned to investigate the effects of oily and dry neonatal massage on hyperbilirubinemia and comfort.
Read the detailed description
Hyperbilirubinemia is a common disease affecting newborns. It is a self-limiting condition, but if not properly monitored and managed, it can cause permanent neurological disorders. Hyperbilirubinemia affects approximately 8-11% of newborns and accounts for 75% of hospitalizations in the first weeks of life. Physiological jaundice occurs in newborns within the first 24-72 hours after birth; it is at its highest level on days 3-4, begins to decrease on days 5-7 and disappears completely on days 10-14, and in premature babies, it occurs after 48 hours and can take up to 4 weeks to completely resolve. Jaundice that occurs within the first 24 hours is pathological jaundice. High bilirubin levels can cause kernicterus, which can lead to serious neurological damage if not diagnosed and treated early. This condition has a 75% probability of death in infants and can cause neurological sequelae in 80% of survivors. Different treatment methods are used to reduce bilirubin levels. Frequently used methods are; exchange transfusion, phototherapy and drug therapy. Phototherapy is one of the most frequently used methods in the treatment of hyperbilirubinemia. Phototherapy has many complications such as damage to the retina and reproductive organs, dehydration in the body, skin rashes, watery stools and bronze baby syndrome. Recently, research has been conducted on different treatment approaches and new applications to manage neonatal hyperbilirubinemia and shorten the hospitalization period. It has been stated that massage and bath applications reduce bilirubin levels in newborns. Massage is the systematic manual stimulation of the soft tissues of the body with movements such as friction, pressing, rolling and touching for therapeutic purposes. Massage, which is one of the oldest healing applications and can be easily applied together with traditional treatments, is the most natural and instinctive tools.Massage in newborns is accepted as a new care method with positive effects.Neonatal massage is not a mechanical routine, but a simple, cheap and effective technique to support newborn development and to ensure that parents establish eye contact with their babies. Massage is a new, easy to apply and alternative method that can be used to reduce bilirubin levels in newborns. Baby massage can help to remove bilirubin from the body by increasing lymph and blood circulation. Massage stimulates bowel movements and causes early defecation. Increased intestinal peristalsis reduces the enterohepatic circulation of bilirubin and accelerates its excretion from the body. Studies have shown that massage significantly increases the frequency of defecation in babies. Baby massage can significantly increase the number of stools by significantly increasing the intestinal stimulation of babies with vagal activity and thus help to remove bilirubin from the body. In the findings of many studies; it has been reported that baby massage is a method that helps to remove bilirubin from the body.
- Conditions
- Hyperbilirubinemia, Neonatal
- Being tested
- Dry Full Body Massage, Oil Full Body Massage
- Keywords
- hyperbilirubinemia, massage, comfort, newborn
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Full Body MassageOther
Applying massage after phototherapy
Oil Full Body MassageOther
Oil Full Body Massage
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Babies in the control group will receive treatment and care according to neonatal intensive care unit procedures. No intervention will be applied. |
| Dry Full Body Massage Group | Experimental | Unlike the control group, dry whole body massage was applied to the babies who were followed up after completing the phototherapy treatment process. Receives: Other: Dry Full Body Massage |
| Oil Full Body Massage Group | Experimental | Unlike the control group, the babies in this group received a full body oil massage. The full body oil massage was applied using pure baby olive oil. Receives: Other: Oil Full Body Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Comfort Behavior Scale (COMFORTneo)
The Newborn Comfort Behavior Scale, developed to determine sedation, need for comfort, pain or distress in infants followed in the NICU, is a five-point Likert-type scale. The five-point Likert-type scale consists of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. In infants receiving mechanical ventilation, the "Respiratory Response" element is taken into account, and in those not receiving mechanical ventilation, the "Crying" element is taken into account.
Measured: 9 months
Numerical Assessment Scales
Numerical Assessment Scales are based on the observation of the researcher. Each item in the scale is scored from 1 to 5 and evaluated over a total score. The lowest score on the scale should be 6 and the highest score should be 30. If the total score obtained from the scale is between 9-13, it means that the newborn is comfortable, and if it is between 14-30, it means that the newborn is in pain or distress and therefore not comfortable.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbilirubinemia, NeonatalStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consisted of 3 groups: control group, dry whole body massage group and oily whole body massage group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- meral güven
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, meral güven, Igdir University
- Investigators
- meral güven, Principal investigator, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630689
- Sponsor's protocol ID
- IU-SBF-MG-01
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't prefer
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oil and Dry Neonatal Massage on Hyperbilirubinemia and Comfort
- ClinicalTrials.gov ID
- NCT06630689
- Acronym / sponsor ID
- IU-SBF-MG-01
- Conditions
- Hyperbilirubinemia, Neonatal
- Keywords
- hyperbilirubinemia, massage, comfort, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- meral güvenUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 8 Oct 2024 (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.
The need for infant massage may come to the forefront as a part of routine care in the neonatal intensive care unit to reduce high bilirubin levels in newborns and to reduce the need for phototherapy treatment. This study was planned to investigate the effects of oily and dry neonatal massage on hyperbilirubinemia and comfort.
Detailed description
Hyperbilirubinemia is a common disease affecting newborns. It is a self-limiting condition, but if not properly monitored and managed, it can cause permanent neurological disorders. Hyperbilirubinemia affects approximately 8-11% of newborns and accounts for 75% of hospitalizations in the first weeks of life. Physiological jaundice occurs in newborns within the first 24-72 hours after birth; it is at its highest level on days 3-4, begins to decrease on days 5-7 and disappears completely on days 10-14, and in premature babies, it occurs after 48 hours and can take up to 4 weeks to completely resolve. Jaundice that occurs within the first 24 hours is pathological jaundice. High bilirubin levels can cause kernicterus, which can lead to serious neurological damage if not diagnosed and treated early. This condition has a 75% probability of death in infants and can cause neurological sequelae in 80% of survivors. Different treatment methods are used to reduce bilirubin levels. Frequently used methods are; exchange transfusion, phototherapy and drug therapy. Phototherapy is one of the most frequently used methods in the treatment of hyperbilirubinemia. Phototherapy has many complications such as damage to the retina and reproductive organs, dehydration in the body, skin rashes, watery stools and bronze baby syndrome. Recently, research has been conducted on different treatment approaches and new applications to manage neonatal hyperbilirubinemia and shorten the hospitalization period. It has been stated that massage and bath applications reduce bilirubin levels in newborns. Massage is the systematic manual stimulation of the soft tissues of the body with movements such as friction, pressing, rolling and touching for therapeutic purposes. Massage, which is one of the oldest healing applications and can be easily applied together with traditional treatments, is the most natural and instinctive tools.Massage in newborns is accepted as a new care method with positive effects.Neonatal massage is not a mechanical routine, but a simple, cheap and effective technique to support newborn development and to ensure that parents establish eye contact with their babies. Massage is a new, easy to apply and alternative method that can be used to reduce bilirubin levels in newborns. Baby massage can help to remove bilirubin from the body by increasing lymph and blood circulation. Massage stimulates bowel movements and causes early defecation. Increased intestinal peristalsis reduces the enterohepatic circulation of bilirubin and accelerates its excretion from the body. Studies have shown that massage significantly increases the frequency of defecation in babies. Baby massage can significantly increase the number of stools by significantly increasing the intestinal stimulation of babies with vagal activity and thus help to remove bilirubin from the body. In the findings of many studies; it has been reported that baby massage is a method that helps to remove bilirubin from the body.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The study consisted of 3 groups: control group, dry whole body massage group and oily whole body massage group.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Babies in the control group will receive treatment and care according to neonatal intensive care unit procedures. No intervention will be applied. |
| Dry Full Body Massage Group | Experimental | Other: Dry Full Body MassageUnlike the control group, dry whole body massage was applied to the babies who were followed up after completing the phototherapy treatment process. |
| Oil Full Body Massage Group | Experimental | Other: Oil Full Body MassageUnlike the control group, the babies in this group received a full body oil massage. The full body oil massage was applied using pure baby olive oil. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Being a term (37-42 weeks) newborn.
- The newborn's postnatal age is between 1st and 28th days
- The 1st and 5th Apgar score is between 7-10
- The newborn is fed orally
- The newborn's birth weight is 2500 grams and above
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Dry Full Body MassageApplying massage after phototherapy | Other | Dry Full Body Massage Group |
| Oil Full Body MassageOil Full Body Massage | Other | Oil Full Body Massage Group |
Primary outcome
Newborn Comfort Behavior Scale (COMFORTneo)
Time frame: 9 months
The Newborn Comfort Behavior Scale, developed to determine sedation, need for comfort, pain or distress in infants followed in the NICU, is a five-point Likert-type scale. The five-point Likert-type scale consists of six parameters including alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. In infants receiving mechanical ventilation, the "Respiratory Response" element is taken into account, and in those not receiving mechanical ventilation, the "Crying" element is taken into account.
Numerical Assessment Scales
Time frame: 9 months
Numerical Assessment Scales are based on the observation of the researcher. Each item in the scale is scored from 1 to 5 and evaluated over a total score. The lowest score on the scale should be 6 and the highest score should be 30. If the total score obtained from the scale is between 9-13, it means that the newborn is comfortable, and if it is between 14-30, it means that the newborn is in pain or distress and therefore not comfortable.
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 15 Oct 2024.
- Individual participant dataSharing planned: No. I don't prefer
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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.
meral güven principal investigator
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Full Body Massage and Oil Full Body Massage in people with Hyperbilirubinemia, Neonatal, run by meral güven 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 10 inclusion and 1 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 15 Oct 2024. 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?
Newborn Comfort Behavior Scale (COMFORTneo) (time frame: 9 months). 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 15 Oct 2024.