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.

Inclusion Criteria:

• Diagnosed with hypoxic-ischemic encephalopathy
• Undergoing therapeutic hypothermia
• Hemodynamically stable neonates

Exclusion Criteria:

• Major congenital anomalies
• Hemodynamic instability
• Skin integrity problems preventing foot reflexology

Reasons for Non-Disclosure of IPD The sharing of Individual Participant Data (IPD) is primarily restricted due to ethical and legal obligations regarding participant confidentiality. In clinical studies involving vulnerable populations, such as neonates undergoing Therapeutic Hypothermia, protecting the identity of subjects is paramount.

Key reasons include:

Privacy and Data Protection: Strict adherence to data protection regulations (e.g., GDPR, KVKK) prevents the public sharing of raw data that could lead to the de-identification of participants.

Ethical Constraints: The informed consent obtained from legal guardians often specifies that data will only be used for the primary research purpose and shared only with authorized regulatory bodies, not the general public.

Institutional Policies: Hospital and university ethics committees may prohibit the open-access sharing of sensitive clinical data to prevent potential misuse or misinterpretation of raw biological and physiological pa