MedTrace Logo

Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

NCT07549789 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • Effect of Reflexology
  • Hypoxic-Ischemic Encephalopathy, Neonatal
  • Foot Reflexology
  • Therapeutic Hypothermia

Interventions

OTHER

Foot reflexology

A standardized foot reflexology protocol will be applied for 7 minutes (3.5 minutes per foot) once daily for three consecutive days during therapeutic hypothermia. The technique includes thumb walking and rotational pressure targeting specific reflex zones. The intervention is administered under controlled thermal conditions to avoid physiological instability.

OTHER

Standard care

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

Sponsors & Collaborators

  • Istanbul Nisantasi University

    lead OTHER

Principal Investigators

  • Alev S Sivaslı, PhD · istanbul nişantaşı üniversitesi

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Minutes
Max Age
3 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-01-31
Completion
2027-03-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07549789 on ClinicalTrials.gov