Kuşadası State Hospital
Aydin, Kuşadası, 09400, Turkey (Türkiye)
NCT Number: NCT07610811
Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns.
This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy.
A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention.
The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.
Trial opening soon.
Get Notified2 day–10 day
All sexes
Interventional
Not applicable
Aydin, Kuşadası, 09400, Turkey (Türkiye)
Neonatal hyperbilirubinemia is one of the most common conditions requiring hospitalization in the early neonatal period. Although phototherapy is the standard treatment, it may be associated with potential short- and long-term adverse effects, including dehydration, thermoregulation disturbances, and increased stress responses. Therefore, there is growing interest in complementary, non-invasive interventions that may enhance treatment effectiveness and improve neonatal outcomes.
Massage therapy and foot reflexology are commonly used complementary interventions in neonatal care. These interventions are thought to stimulate the gastrointestinal system, increase bowel movements, and facilitate bilirubin excretion. In addition, they may contribute to improved physiological stability and reduced stress levels through tactile stimulation.
This study is designed as a randomized controlled trial to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters, and stress levels in neonates receiving phototherapy. Physiological parameters include heart rate, respiratory rate, oxygen saturation, and body temperature.
The study will be conducted in a neonatal intensive care unit and will include 105 neonates diagnosed with indirect hyperbilirubinemia. Participants will be randomly assigned to one of three groups: foot reflexology group, body massage group, and control group. Interventions will be administered prior to phototherapy sessions.
Data will be collected using standardized tools, including a Neonatal Information Form, Neonatal Follow-up Form, and a validated Neonatal Stress Scale. Outcome measures will be assessed before and after the interventions.
The findings of this study are expected to provide evidence on the effectiveness of complementary non-pharmacological interventions in reducing bilirubin levels, improving physiological stability, and decreasing stress in neonates. These results may contribute to the integration of evidence-based complementary practices into neonatal care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Phototherapy will be provided using a standard phototherapy device according to the neonatal intensive care unit's routine clinical protocol for the management of neonatal indirect hyperbilirubinemia.
Time frame: Immediately before and immediately after each phototherapy session.
Total serum bilirubin level will be measured to evaluate the effect of foot reflexology and body massage on bilirubin reduction in neonates receiving phototherapy.
Time frame: Immediately before and immediately after each phototherapy session.
Heart rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as beats per minute.
Time frame: Immediately before and immediately after each phototherapy session.
Respiratory rate will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as breaths per minute.
Time frame: Immediately before and immediately after each phototherapy session.
Oxygen saturation will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported as percentage oxygen saturation.
Time frame: Immediately before and immediately after each phototherapy session.
Body temperature will be assessed immediately before and immediately after each phototherapy session. The outcome will be reported in degrees Celsius.
Time frame: Immediately before and immediately after each phototherapy/intervention session.
Neonatal stress level will be evaluated using the Newborn Stress Scale developed by Ceylan and Bolışık. This observational scale includes eight domains: facial expression, body color, respiration, activity level, consolability, muscle tone, extremities, and posture. Each domain reflects observable behavioral or physiological stress responses in the newborn, such as changes in facial expression, skin color, breathing pattern, motor activity, ability to be consoled, muscle tension, limb movements, and body posture. Items are scored from 0 to 2, with higher scores indicating a higher level of neonatal stress. The outcome will be reported as the total scale score.
Contact information is provided by the study sponsor or research team.
ayten taspinar, Professor
CONTACT
yagmur karadas, PhD
CONTACT
Aydin Adnan Menderes University
Other
Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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