Foot Reflexology and Massage in Neonates Receiving Phototherapy

Aydin Adnan Menderes University

Status: Not yet enrolling

Conditions: Neonatal Hyperbilirubinemia

Treatments: Behavioral: Body Massage; Device: Phototherapy Device; Behavioral: Foot Reflexology

Study type: Interventional

Funder types: Other

Identifiers

NCT07610811

2025/008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 2 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Foot Reflexology Group

Experimental group

Description:

Neonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions.

Treatment:

Behavioral: Foot Reflexology

Body Massage Group

Experimental group

Description:

Neonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions.

Treatment:

Behavioral: Body Massage

Control Group

Active Comparator group

Description:

Neonates in this group will receive standard phototherapy care only without any additional intervention.

Treatment:

Device: Phototherapy Device