Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

Hypoxic-ischemic encephalopathy (HIE) is a major cause of neonatal morbidity and mortality, and therapeutic hypothermia (TH) is the standard treatment to reduce neurological injury. However, during TH, the management of pain, distress, and comfort remains challenging, and evidence regarding optimal supportive care strategies is limited. Pharmacological approaches may have potential adverse effects, highlighting the need for safe and effective non-pharmacological interventions.

Foot reflexology is a complementary therapy based on the stimulation of specific points on the feet, which is thought to promote autonomic regulation, improve circulation, and enhance relaxation. In neonatal populations, existing studies on reflexology and similar tactile interventions have primarily focused on procedural pain and short-term outcomes. Evidence regarding sustained comfort and physiological regulation, particularly in critically ill neonates undergoing therapeutic hypothermia, remains scarce.

This study is designed as a randomized controlled trial to evaluate the effect of foot reflexology on comfort and physiological parameters in neonates with HIE undergoing TH. Participants will be randomly assigned to either an intervention group receiving foot reflexology in addition to routine care or a control group receiving routine care alone.

The reflexology intervention will be applied in a standardized manner during the hypothermia period by a trained practitioner. The protocol is structured to ensure consistency, safety, and compatibility with intensive care conditions.

Comfort will be assessed using the COMFORTneo scale, a validated and reliable tool for evaluating prolonged pain and distress in neonates. In addition, physiological parameters including heart rate, respiratory rate, oxygen saturation, mean arterial pressure, and body temperature will be monitored to assess physiological stability.

The primary objective of this study is to determine whether foot reflexology improves comfort levels in neonates undergoing TH. Secondary objectives include evaluating its effects on physiological parameters and assessing the safety of the intervention in this vulnerable population.

The findings of this study are expected to contribute to the evidence base for non-pharmacological supportive care in neonatal intensive care units and may support the integration of reflexology into clinical practice if proven effective and safe.

Inclusion criteria

• Gestational age ≥36 weeks
• Therapeutic hypothermia initiated within the first 6 hours after birth for hypoxic-ischemic encephalopathy
• Moderate or severe hypoxic-ischemic encephalopathy according to the modified Sarnat classification
• Evidence of perinatal hypoxia, including umbilical cord or early postnatal blood gas pH ≤7.00 or base excess ≤-16 mmol/L within the first hour of life, or a 10-minute Apgar score <5 or ongoing resuscitation
• Not receiving invasive mechanical ventilation
• Clinically stable for the intervention as determined by the attending neonatologist
• Written informed consent obtained from a parent or legal guardian

Exclusion criteria

• Invasive mechanical ventilation
• Major congenital anomaly
• Severe intracranial hemorrhage
• Multiple organ failure
• Skin lesion, trauma, or vascular access involving the lower extremities that could interfere with foot reflexology
• Active resuscitation
• Severe hemodynamic instability
• Uncontrolled seizures or neurological deterioration compromising intervention safety
• Any clinical event or device/airway/vascular access concern preventing safe administration of the intervention