Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

NCT07549789 | Not Yet Recruiting

• 1 other identifier: 06.02.2025/SBETKK2025-02
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Foot reflexology; therapeutic hypothermia; Hypoxic-Ischemic Encephalopathy; ComfortNeo

Outcome Measures

Primary Outcomes (6)

• ComfortNeo score

  The COMFORTneo scale is a clinically validated tool specifically designed to assess prolonged pain and distress in preterm and term neonates within the NICU. It is a modification of the original COMFORT scale, optimized for newborn physiology. The scale evaluates six behavioral parameters, each scored from 1 to 5: Alertness: State of sleep or wakefulness. Calmness/Agitation: Level of anxiety or peacefulness. Respiratory Response/Crying: Quality of breathing or crying intensity. Physical Movement: Frequency and vigor of body activity. Muscle Tone: Level of bodily tension or relaxation. Facial Tension: Presence of grimacing or tension. Total scores range from 6 to 30. A cutoff score of 14 or higher typically indicates significant distress, requiring clinical intervention. It is ideal for monitoring sedation and comfort in neonates undergoing Therapeutic Hypothermia.

  From baseline up to 72 hours after intervention

• Outcome

  Heart Rate

  Immediately before and within 10 minutes after each session for 3 consecutive days

• Outcome

  Respiratory Rate

  Immediately before and within 10 minutes after each session for 3 consecutive days

• Outcome

  Oxygen Saturation

  Immediately before and within 10 minutes after each session for 3 consecutive days

• Outcome

  Mean Arterial Pressure

  Immediately before and within 10 minutes after each session for 3 consecutive days

• Outcome

  Body Temperature

  Immediately before and within 10 minutes after each session for 3 consecutive days

Study Arms (2)

Foot Reflexology

EXPERIMENTAL

Foot reflexology will be applied in addition to standard care during therapeutic hypothermia. Each session will last approximately 7 minutes (3.5 minutes per foot) and will be performed once daily for three consecutive days by a trained healthcare professional using standardized techniques.

Other: Foot reflexology

Standard Care

ACTIVE COMPARATOR

Participants will receive standard therapeutic hypothermia and routine neonatal intensive care without any additional tactile stimulation or reflexology.

Other: Standard care

Interventions

Foot reflexology OTHER

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.

Foot Reflexology

Standard care OTHER

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

Standard Care

Eligibility Criteria

• Age: 30 Minutes - 3 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Nisantasi University: lead

Study Sites (1)

Nisantasi University

Istanbul, Sarıyer, 27590, Turkey (Türkiye)

Location

Related Links

• Official resource for the COMFORTneo pain assessment scale.

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alev S Sivaslı, PhD

  istanbul nişantaşı üniversitesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alev S Sivaslı, PhD

CONTACT

+905076661069; aesivasli@gmail.com

Ercan S Sivaslı, Professor

CONTACT

+90 5343420027; esivasli@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the intervention group or the control group using a parallel-group design with a 1:1 allocation ratio. The intervention group will receive standardized foot reflexology in addition to routine neonatal intensive care, while the control group will receive routine care only. The study follows a parallel assignment model in which both groups are observed over the same therapeutic hypothermia period. The intervention is administered repeatedly to evaluate both immediate and cumulative effects on comfort and physiological parameters. Outcome measures are collected at predefined time points across the study period to allow comparison between groups and over time. Blinding will be applied at the level of outcome assessment to minimize bias.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)