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Foot Reflexology in Neonates With Hypoxic-Ischemic Encephalopathy

ConditionsEffect of ReflexologyHypoxic-Ischemic Encephalopathy, NeonatalFoot ReflexologyTherapeutic Hypothermia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-3
SponsorIstanbul Nisantasi University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with hypoxic-ischemic encephalopathy

Undergoing therapeutic hypothermia

Hemodynamically stable neonates

Disqualifiers

Major congenital anomalies

Hemodynamic instability

Skin integrity problems preventing foot reflexology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Foot reflexology

    Other intervention

    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.

  • Standard care

    Other intervention

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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Foot ReflexologyExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From baseline up to 72 hours after intervention
2

Outcome

Heart Rate

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

Outcome

Respiratory Rate

Time frame
Immediately before and within 10 minutes after each session for 3 consecutive days
4

Outcome

Oxygen Saturation

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Nisantasi University

Lead sponsor

Source ClinicalTrials.gov

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