- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409194
The Effect of Acupressure on Hyperbilirubinemia in Newborns: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
One of the most common problems encountered in the neonatal period is neonatal jaundice, which develops due to an increase in indirect bilirubin (Özdemir and Yılmaz, 2019). Jaundice (hyperbilirubinemia) is defined as the yellowing of the skin and the whites of the eyes due to the accumulation of bilirubin in the skin and mucous membranes of newborns (Kılıç and Yılmaz, 2021). Jaundice is a common condition seen in 60% of term infants and more than 80% of preterm infants (Muniyappa and Kelley, 2020). Hyperbilirubinemia (HB), which is frequently seen in newborns, especially in the indirect form, is a mild health problem in most cases (Olcar, 2019; Yılmaz, 2019). HB in newborns usually progresses cephalocaudally (from head to toe); it starts in the face and spreads to the body as serum bilirubin levels increase (Turkish Neonatology Association [TND], 2022). Symptoms such as lethargy and feeding difficulties may occur in infants with severe HB. If not treated promptly, serious neurological complications such as kernicterus may occur. Early diagnosis, close monitoring, and treatment are vital to prevent potential damage in newborns (Muniyappa and Kelley, 2020).
Various treatment methods have been developed to reduce bilirubin levels. Among these methods, the most commonly used are blood exchange, phototherapy, and drug treatments (Garg et al., 2019; Kılıç and Yılmaz, 2021). To support neonatal HB treatment, studies evaluating the effectiveness of non-pharmacological and complementary applications, in addition to pharmacological methods, have also been conducted (Öztürk, 2025; Coşkun and Karakoç., 2025; Wu et al., 2022).
Acupressure is a complementary treatment method that aims to control symptoms by applying pressure to specific points on the meridians (İskender and Çalışkan, 2020). During the application, sensitive pressure is applied to specific points on the body using the hands and fingers, and in some cases, special tools; this aims to regulate energy flow and support the body's natural healing processes (Dincer et al., 2022; Harris et al., 2020). These stimuli, applied through touch, can activate receptors in the skin of infants with HB and be transmitted to the brain centers via reflex pathways. This can stimulate the parasympathetic nervous system and the vagus nerve, accelerating bowel movements, contributing to the regulation of the digestive system, and helping to expel meconium more quickly (Roth and Sullivan, 2006). In this regard, it is crucial to correctly identify the appropriate acupressure points during the treatment process (Bayraktar, 2023).
The application of acupressure has been used in various clinical settings in the neonatal and pediatric populations, and its effects on different physiological outcomes have been investigated. The effects of acupressure on pain (Altıntaş, 2023; Oğul, 2023; Özkan and Balcı, 2018), infantile colic (Özgören, 2021), and chemotherapy-induced nausea and vomiting (Balcı, 2018) in the pediatric group have been examined in various studies. However, it has been determined that studies evaluating the effect of acupressure on HB in newborns (Wu et al., 2022) are quite limited. Therefore, the aim of this study is to evaluate the effect of acupressure applied to newborns on HB. In this context, the potential contributions of acupressure to reducing serum bilirubin levels and supporting the treatment process will be examined, and it is aimed that the findings will provide scientific evidence regarding the effectiveness of acupressure as a complementary approach in the management of hyperbilirubinemia and guide clinical practice.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Van, Turkey (Türkiye), 65100
- Van Yüzüncü Yil University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Gestational age ≥38 weeks
- Diagnosed with neonatal hyperbilirubinemia
- Hospitalized in the neonatal unit for at least 24 hours
- Birth weight ≥2500 g
- Written informed consent obtained from parents
Exclusion Criteria:
- Preterm newborns
- Congenital metabolic disease or congenital anomalies
- Hemodynamically unstable newborns
- Newborns whose parents did not provide consent
- Newborns with any condition preventing acupressure application
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Acupressure Group
Newborns assigned to the intervention group receive standard acupressure at predetermined acupuncture points (ST36 - Zusanli and KI1 - Yongquan) by a trained practitioner 0 and 12 hours after birth.
Each session lasts approximately 4 minutes.
Total serum bilirubin levels are measured 24 hours after birth.
All newborns continue to receive routine newborn care and feeding according to the unit protocol.
|
Acupressure intervention
|
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No Intervention: Control Group
Newborns assigned to the control group receive routine neonatal care and feeding according to unit protocol without any acupressure intervention.
Total serum bilirubin levels are measured at the 24th hour of life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Serum Bilirubin Level
Time Frame: 24 hours after birth
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Measurement of total serum bilirubin level to evaluate the effect of acupressure on neonatal hyperbilirubinemia.
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24 hours after birth
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Veysel CAN, MD, PhD, Yuzuncu Yil University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/05-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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