Набор скоро начнётся NCT07651592

MOTHER3SENSE Study

Без фазы С лечением Neonatal Pain Stress, Psychological

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: Maternal Voice, Maternal Touch, Maternal Scent.
Кому может быть актуально: Состояния в реестре: Neonatal Pain, Stress, Psychological. Базовые параметры: 0 Days — 28 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 Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions

Обзор

This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.

Подробное описание

Painful procedures are frequently performed in newborns during routine clinical care and may lead to physiological and behavioral stress responses. Non-pharmacological interventions are recommended as safe and effective approaches for reducing procedural pain and stress in newborns. Maternal sensory stimuli, including maternal voice, touch, and scent, may provide comfort and support neonatal regulation during painful procedures.

This randomized controlled trial aims to compare the effects of maternal voice, maternal touch, and maternal scent on pain and stress responses in newborns undergoing a routine heel lance procedure. Eligible newborns will be randomly assigned to one of four groups: maternal voice, maternal touch, maternal scent, or control.

The assigned intervention will be applied according to a standardized protocol before, during, and after the heel lance procedure. Pain and stress responses will be assessed at three time points: before the procedure, during the procedure, and after the procedure. Behavioral and physiological indicators will be used to evaluate neonatal pain and stress responses.

The primary objective of the study is to determine and compare the effectiveness of maternal voice, touch, and scent in reducing procedural pain and stress in newborns. The findings may contribute to evidence-based, family-centered, and non-pharmacological pain management practices in neonatal care.

Вмешательства

Другое Maternal Voice
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
Другое Maternal Touch
The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
Другое Maternal Scent
The newborn will be exposed to maternal breast milk scent during the procedure.

Первичные конечные точки

Neonatal Infant Pain Scale [Срок оценки: Before the procedure, during the procedure, and immediately after the procedure]

Вторичные конечные точки (1)

Newborn stress scale [Срок оценки: Before the procedure, during the procedure, and immediately after the procedure]

Критерии участия

Критерии включения

Term newborns born between 37 and 42 weeks of gestation
Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases
Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment
Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)
Mothers willing to participate in the study
Written informed consent provided by the parent or legal guardian
Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)