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临床试验/NCT07610811
NCT07610811招募中不适用

Effects of Foot Reflexology and Massage on Total Serum Bilirubin, Physiological Parameters, and Stress in Neonates Receiving Phototherapy: A Randomized Controlled Trial

Aydin Adnan Menderes University2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2026年5月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
105
试验地点
2
主要终点
Total Serum Bilirubin Level

研究概览

简要总结

Neonatal hyperbilirubinemia is a common condition in newborns and is frequently treated with phototherapy. In addition to standard treatment, non-pharmacological interventions such as massage and foot reflexology may help reduce bilirubin levels and improve physiological stability and stress in newborns.

This randomized controlled trial aims to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature), and stress levels in neonates receiving phototherapy.

A total of 105 newborns will be randomly assigned to three groups: foot reflexology, body massage, and control group. Interventions will be applied before phototherapy sessions, and outcomes will be measured before and after the intervention.

The findings of this study are expected to provide evidence for the use of non-invasive complementary methods in reducing bilirubin levels and improving clinical outcomes in newborns.

详细描述

Neonatal hyperbilirubinemia is one of the most common conditions requiring hospitalization in the early neonatal period. Although phototherapy is the standard treatment, it may be associated with potential short- and long-term adverse effects, including dehydration, thermoregulation disturbances, and increased stress responses. Therefore, there is growing interest in complementary, non-invasive interventions that may enhance treatment effectiveness and improve neonatal outcomes.

Massage therapy and foot reflexology are commonly used complementary interventions in neonatal care. These interventions are thought to stimulate the gastrointestinal system, increase bowel movements, and facilitate bilirubin excretion. In addition, they may contribute to improved physiological stability and reduced stress levels through tactile stimulation.

This study is designed as a randomized controlled trial to evaluate the effects of foot reflexology and body massage on total serum bilirubin levels, physiological parameters, and stress levels in neonates receiving phototherapy. Physiological parameters include heart rate, respiratory rate, oxygen saturation, and body temperature.

The study will be conducted in a neonatal intensive care unit and will include 105 neonates diagnosed with indirect hyperbilirubinemia. Participants will be randomly assigned to one of three groups: foot reflexology group, body massage group, and control group. Interventions will be administered prior to phototherapy sessions.

Data will be collected using standardized tools, including a Neonatal Information Form, Neonatal Follow-up Form, and a validated Neonatal Stress Scale. Outcome measures will be assessed before and after the interventions.

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
None

入排标准

年龄范围
2 Days 至 10 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Neonates whose parents/legal guardians have signed the informed consent form and agreed to participate in the study
  • •Neonates born between 34 and 41 weeks of gestation
  • •Birth weight of 2500 g or above
  • •Not mechanically ventilated
  • •No nasogastric tube
  • •Stable vital signs
  • •No elevated acute phase reactants during phototherapy treatment
  • •Indirect bilirubin level between 12 and 28 mg/dL at admission to the neonatal intensive care unit
  • •Not receiving antibiotic treatment during the study
  • •Aged between 2 and 10 days
  • •No health problems other than indirect hyperbilirubinemia.

排除标准

  • •Presence of any neurological anomaly
  • •Presence of any congenital anomaly
  • •Jaundice due to ABO incompatibility
  • •Jaundice due to Rh incompatibility
  • •Presence of dermal anomalies
  • •Diagnosis of hyperbilirubinemia within the first 24 hours after birth
  • •Diagnosis of direct hyperbilirubinemia

研究组 & 干预措施

Control Group

Active Comparator

Neonates in this group will receive standard phototherapy care only without any additional intervention.

干预措施: Phototherapy Device (Device)

Body Massage Group

Experimental

Neonates in this group will receive body massage in addition to standard phototherapy care prior to phototherapy sessions.

干预措施: Body Massage (Behavioral)

Foot Reflexology Group

Experimental

Neonates in this group will receive foot reflexology in addition to standard phototherapy care prior to phototherapy sessions.

干预措施: Foot Reflexology (Behavioral)

结局指标

主要结局

Total Serum Bilirubin Level

时间窗: Immediately before and immediately after each phototherapy session.

Total serum bilirubin level will be measured to evaluate the effect of foot reflexology and body massage on bilirubin reduction in neonates receiving phototherapy.

次要结局

  • Heart rate(Immediately before and immediately after each phototherapy session.)
  • Respiratory Rate(Immediately before and immediately after each phototherapy session.)
  • Oxygen Saturation(Immediately before and immediately after each phototherapy session.)
  • Body Temperature(Immediately before and immediately after each phototherapy session.)
  • Neonatal Stress Level(Immediately before and immediately after each phototherapy/intervention session.)

研究者

发起方
Aydin Adnan Menderes University
申办方类型
Other
责任方
Principal Investigator
主要研究者

yagmur karadas

Principal Investigator

Aydin Adnan Menderes University

研究点 (2)

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