Foot Reflexology and Massage in Neonates Receiving Phototherapy

Official title

Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

• Behavioral Foot Reflexology
  Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
• Behavioral Body Massage
  Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
• Device Phototherapy Device
  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.

Primary outcome measures

• Total Serum Bilirubin Level [Time frame: Immediately before and immediately after each phototherapy session.]

Secondary outcome measures (5)

• Heart rate [Time frame: Immediately before and immediately after each phototherapy session.]
• Respiratory Rate [Time frame: Immediately before and immediately after each phototherapy session.]
• Oxygen Saturation [Time frame: Immediately before and immediately after each phototherapy session.]
• Body Temperature [Time frame: Immediately before and immediately after each phototherapy session.]
• Neonatal Stress Level [Time frame: Immediately before and immediately after each phototherapy/intervention session.]

Eligibility criteria

Inclusion criteria

• Neonates whose parents/legal guardians have signed the informed consent form and agreed to participate in the study
• Neonates born between 34 and 41 weeks of gestation
• Birth weight of 2500 g or above
• Not mechanically ventilated
• No nasogastric tube
• Stable vital signs
• No elevated acute phase reactants during phototherapy treatment
• Indirect bilirubin level between 12 and 28 mg/dL at admission to the neonatal intensive care unit
• Not receiving antibiotic treatment during the study
• Aged between 2 and 10 days
• No health problems other than indirect hyperbilirubinemia.

Exclusion criteria

• Presence of any neurological anomaly
• Presence of any congenital anomaly
• Jaundice due to ABO incompatibility
• Jaundice due to Rh incompatibility
• Presence of dermal anomalies
• Diagnosis of hyperbilirubinemia within the first 24 hours after birth
• Diagnosis of direct hyperbilirubinemia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Kuşadası State Hospital — Aydin

Identifiers

NCT: NCT07610811 · 2025/008

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗