Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

Istanbul Nisantasi University84 enrolled

Overview

This randomized controlled trial aims to evaluate the effect of foot reflexology on comfort levels and physiological parameters in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia. Neonates in the intervention group will receive standardized foot reflexology sessions in addition to routine care, while the control group will receive routine care alone. Comfort will be assessed using the COMFORTneo scale, and physiological parameters will be monitored throughout the intervention period.

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.

Interventions

Foot reflexologyOTHER

A standardized foot reflexology protocol was administered three times daily at approximately 8-hour intervals for 72 hours. Each session lasted 15 minutes, with equal time allocated to both feet, resulting in nine sessions and a cumulative intervention time of 135 minutes per participant. The intervention targeted four protocol-defined foot areas: the head/brain, solar plexus, spine, and diaphragm zones. Light-to-moderate pressure was applied, while abrupt, forceful, or painful pressure was avoided. No oil, lotion, or warming material was used. All sessions were performed by the same trained and certified researcher under continuous clinical monitoring and predefined safety stopping criteria.

Standard careOTHER

Standard therapeutic hypothermia and routine neonatal intensive care without additional tactile stimulation.

Eligibility

Sex: ALLMin age: 0 Days

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

COMFORTneo score

COMFORTneo was used to assess pain and distress in neonates. The scale consists of six behavioral items scored from 1 to 5, yielding a total score ranging from 6 to 30. Higher scores indicate greater pain or distress. COMFORTneo assessments were performed at baseline (T0), 24 hours (T1), 48 hours (T2), and 72 hours (T3) by an outcome assessor blinded to group allocation.

Time frame: Baseline, 24 hours, 48 hours, and 72 hours

Secondary Outcomes

Heart rate

Heart rate (beats/min) was recorded immediately before and immediately after one designated foot reflexology session per day for three consecutive days. For each participant, the three pre-session values and the three post-session values were summarized as participant-level means for analysis.