Effect of Reflexology, Foot Reflexology, Hypoxic-Ischemic Encephalopathy, Neonatal, Therapeutic Hypothermia
Conditions
Keywords
Foot reflexology, therapeutic hypothermia, Hypoxic-Ischemic Encephalopathy, ComfortNeo
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.
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.
Interventions
OTHERFoot 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.
OTHERStandard care
Standard therapeutic hypothermia and routine neonatal intensive care without additional tactile stimulation.
Sponsors
Istanbul Nisantasi University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 3 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ComfortNeo score | 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. |
| Outcome | Immediately before and within 10 minutes after each session for 3 consecutive days | Heart Rate |
Countries
Turkey (Türkiye)
Contacts
CONTACTAlev S Sivaslı, PhD
CONTACTErcan S Sivaslı, Professor
PRINCIPAL_INVESTIGATORAlev S Sivaslı, PhD
istanbul nişantaşı üniversitesi
Outcome results
None listed