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Набор по приглашению NCT06699745

Comparison of the Effects of Music and White Noise in Children Performed Endoscopy

Без фазы С лечением School Age Children Endoscopy, Gastrointestinal

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: Music intervention, white noise intervention.
Кому может быть актуально
Состояния в реестре: School Age Children, Endoscopy, Gastrointestinal. Базовые параметры: 6 лет — 12 лет · 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 →
Официальное название

Comparison of the Effects of Music and White Noise on Fear, Anxiety and Pain Levels in Children Performed Endoscopy

Обзор

The study was planned as a randomized controlled experimental study to compare the effects of music and white noise on fear, anxiety and pain levels before, during and after the procedure in school-age children (6-12 years old) who will undergo endoscopy. Hypothesis 0 (H0): There is no difference in fear, anxiety, pain, parental anxiety and pulse, respiration and oxygen saturation values between children exposed to music and white noise. Hypothesis 1 (H1): Children who were exposed to music and white noise had lower fear scores than children who were not exposed to any application. Hypothesis 2 (H2): Children who were exposed to music and white noise had lower anxiety scores than children who were not exposed to any application. Hypothesis 3 (H3): Children who were exposed to music and white noise had lower pain scores than children who were not exposed to any application. Hypothesis 4 (H4): Children who were exposed to music and white noise had lower pulse value scores than children who were not exposed to any application. Hypothesis 5 (H5): Children who were exposed to music and white noise had lower respiratory rate scores than children who were not exposed to any application. Hypothesis 6 (H6): Children who were exposed to music and white noise had higher oxygen saturation value scores than children who were not exposed to any application. Hypothesis 7 (H7): Parents of children who were exposed to music and white noise had lower parental anxiety than parents of children who were not exposed to any treatment. There are music group, white noise and control group in the study.

Подробное описание

The independent variables of the study are age, gender, music and white noise application.

The dependent variables are; Children's Fear Scale (CFS) scores used to measure children's fear, Children's Anxiety Scale-State (CAS-D) scores used to measure anxiety, The Faces Pain Scale Revised (FPS-R) scores used to measure pain status, pulse, respiratory rate and oxygen saturation values and Beck Anxiety Inventory scores obtained from parents.

Вмешательства

  • Поведенческое Music intervention
    In studies, white noise was used as a sedative in infants. It was not used in older children. In school-age children, white noise will be used to reduce fear, anxiety and pain during the endoscopy procedure.
  • Поведенческое white noise intervention
    White noise will be played at a decibel level appropriate for the children in the group.

Первичные конечные точки

  • Child fear scale [Срок оценки: six months]
  • Child anxiety scale-state [Срок оценки: six months]
  • The Faces Pain Scale - Revised [Срок оценки: six months]
Вторичные конечные точки (4)
  • Beck Anxiety Inventory [Срок оценки: six months]
  • pulse value [Срок оценки: six months]
  • respiratory value [Срок оценки: six months]
  • oxygen saturation value [Срок оценки: six months]

Критерии участия

Критерии включения

  • School age (6-12 years old) child,
  • Have not had an endoscopy procedure before,
  • Have not had a surgical procedure before,
  • Have been requested to have an endoscopy by a physician,
  • Be able to communicate,
  • Have no hearing or speech problems,
  • Agree to participate in the study,
  • Have not used analgesics for 6 hours before the procedure,
  • The child can count from 1 to 10,
  • Have the ability to order numbers (knowing that numbers are big or small (e.g. 6 is less than 7, 4 is greater than 2, etc.).

Критерии исключения

  • Not being of school age (under 6 years old, over 12 years old),
  • Having had an endoscopy procedure before,
  • Having had a surgical procedure before,
  • Not being able to communicate,
  • Having hearing and speech problems,
  • Not agreeing to participate in the study,
  • Having used analgesics up to 6 hours before the procedure,
  • The child not having the ability to sort and count numbers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Istanbul University-Cerrahpasa — Istanbul

Идентификаторы

NCT: NCT06699745 · IUC-LEE-BIY-26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗