Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy (foot massage)

April 17, 2026 updated by: Alev Sivasli, Istanbul Nisantasi University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ercan S Sivaslı, Professor
  • Phone Number: +90 5343420027
  • Email: esivasli@yahoo.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foot Reflexology
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
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.
Active Comparator: Standard Care
Participants will receive standard therapeutic hypothermia and routine neonatal intensive care without any additional tactile stimulation or reflexology.
Other: Standard care
Standard therapeutic hypothermia and routine neonatal intensive care without additional tactile stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ComfortNeo score
Time Frame: From baseline up to 72 hours after intervention

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
Time Frame: Immediately before and within 10 minutes after each session for 3 consecutive days
Heart Rate
Immediately before and within 10 minutes after each session for 3 consecutive days
Outcome
Time Frame: Immediately before and within 10 minutes after each session for 3 consecutive days
Respiratory Rate
Immediately before and within 10 minutes after each session for 3 consecutive days
Outcome
Time Frame: Immediately before and within 10 minutes after each session for 3 consecutive days
Oxygen Saturation
Immediately before and within 10 minutes after each session for 3 consecutive days
Outcome
Time Frame: Immediately before and within 10 minutes after each session for 3 consecutive days
Mean Arterial Pressure
Immediately before and within 10 minutes after each session for 3 consecutive days
Outcome
Time Frame: Immediately before and within 10 minutes after each session for 3 consecutive days
Body Temperature
Immediately before and within 10 minutes after each session for 3 consecutive days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Nisantasi University

Investigators

  • Principal Investigator: Alev S Sivaslı, PhD, istanbul nişantaşı üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06.02.2025/SBETKK2025-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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