Набор скоро начнётся NCT07610811

Foot Reflexology and Massage in Neonates Receiving Phototherapy

Без фазы С лечением Neonatal Hyperbilirubinemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Foot Reflexology, Body Massage, Phototherapy Device.
Кому может быть актуально: Состояния в реестре: Neonatal Hyperbilirubinemia. Базовые параметры: 2 Days — 10 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

The findings of this study are expected to provide evidence on the effectiveness of complementary non-pharmacological interventions in reducing bilirubin levels, improving physiological stability, and decreasing stress in neonates. These results may contribute to the integration of evidence-based complementary practices into neonatal care.

Вмешательства

Поведенческое Foot Reflexology
Foot reflexology will be applied using gentle pressure techniques on specific reflex points of the feet prior to phototherapy sessions.
Поведенческое Body Massage
Body massage will be applied using gentle and systematic touch techniques prior to phototherapy sessions.
Устройство Phototherapy Device
Phototherapy will be provided using a standard phototherapy device according to the neonatal intensive care unit's routine clinical protocol for the management of neonatal indirect hyperbilirubinemia.

Первичные конечные точки

Total Serum Bilirubin Level [Срок оценки: Immediately before and immediately after each phototherapy session.]

Вторичные конечные точки (5)

Heart rate [Срок оценки: Immediately before and immediately after each phototherapy session.]
Respiratory Rate [Срок оценки: Immediately before and immediately after each phototherapy session.]
Oxygen Saturation [Срок оценки: Immediately before and immediately after each phototherapy session.]
Body Temperature [Срок оценки: Immediately before and immediately after each phototherapy session.]
Neonatal Stress Level [Срок оценки: Immediately before and immediately after each phototherapy/intervention session.]

Критерии участия

Критерии включения

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.