Effect of Foot Reflexology on Comfort and Physiological Parameters in Neonates With Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- COMFORTneo score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 0 Days 至 3 Hours（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Foot Reflexology
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.
干预措施: Foot reflexology (Other)
Standard Care
Participants in this arm received standard therapeutic hypothermia and routine neonatal intensive care without any additional tactile intervention or foot reflexology.
干预措施: Standard care (Other)
结局指标
主要结局
COMFORTneo score
时间窗: Baseline, 24 hours, 48 hours, and 72 hours
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.
次要结局
- 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)
研究者
Alev Sivasli
Assistant Professor
Istanbul Nisantasi University