Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

NCT07549789 | Completed

• 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 (1)

• 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.

  Baseline, 24 hours, 48 hours, and 72 hours

Secondary Outcomes (5)

• Heart rate

  Immediately before and immediately after one designated session per day for 3 consecutive days

• Respiratory rate

  Immediately before and immediately after one designated session per day for 3 consecutive days

• Rectal temperature

  Immediately before and immediately after one designated session per day for 3 consecutive days

• Mean arterial pressure (MAP)

  Immediately before and immediately after one designated session per day for 3 consecutive days

• Oxygen saturation (SpO₂)

  Immediately before and immediately after one designated session per day for 3 consecutive days

Study Arms (2)

Foot Reflexology

EXPERIMENTAL

Participants in this arm received standardized foot reflexology in addition to standard care during therapeutic hypothermia. Foot reflexology 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 a total of nine sessions and a cumulative intervention time of 135 minutes per participant. All sessions were performed by the same trained and certified researcher under continuous clinical monitoring and predefined safety stopping criteria.

Other: Foot reflexology

Standard Care

ACTIVE COMPARATOR

Participants in this arm received standard therapeutic hypothermia and routine neonatal intensive care without any additional tactile intervention or foot reflexology.

Other: Standard care

Interventions

Foot reflexology OTHER

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.

Foot Reflexology

Standard care OTHER

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

Standard Care

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Nisantasi University: lead

Study Sites (1)

Gaziantep Anka Hospital

Gaziantep, Gaziantep, 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor who performed the COMFORTneo assessments was blinded to group allocation. Due to the nature of the intervention, the reflexology provider could not be blinded. Group codes were masked during data analysis.
• 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: February 3, 2025
• Primary Completion: August 27, 2026
• Study Completion: August 27, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)