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COMPLETED
NCT07549789
NA

Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

Sponsor: Istanbul Nisantasi University

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Foot Reflexology on Comfort and Physiological Parameters in Neonates With Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

0 Days - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-02-03

Completion Date

2026-08-27

Last Updated

2026-09-23

Healthy Volunteers

No

Interventions

OTHER

Foot reflexology

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.

OTHER

Standard care

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

Locations (1)

Gaziantep Anka Hospital

Gaziantep, Gaziantep, Turkey (Türkiye)