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Набор скоро начнётся NCT06858267

The Impact of Meditation on Anxiety and Post-Operative Pain in Pediatric Patients Undergoing Urological Surgery

Без фазы С лечением Pediatric Kidney Disease

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: PeSSKi questionnaire survey, Meditation Video.
Кому может быть актуально
Состояния в реестре: Pediatric Kidney Disease. Базовые параметры: 6 лет — 18 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

1. The aim of this study is to assess anxiety in pediatric patients preoperatively, perioperatively, and postoperatively and whether meditation reduces anxiety in the days before, during, and after the surgery. 2. The second aim of this study is to see if longitudinal meditation is associated with decreased postoperative pain by examining whether the group prescribed meditation has reduced pain medication intake, measured by the frequency of liquid analgesic medicine intake.

Подробное описание

Up to 70% of pediatric patients experience preoperative and perioperative anxiety. The anxiety level of their parents or guardians also affects the anxiety levels of pediatric patients themselves. Anxiety levels often peak during the time of anesthesia induction, suggesting the unfamiliar physical environment plays a role in increasing anxiety levels. Pediatric anxiety often manifests in various ways such as strong emotions, physical noncompliance, and regression. Pre-operative anxiety has been shown to increase the risk of cardiovascular events during the operation, increase difficulty gaining access to intubation, and increase anesthetic requirements. The effects of pre-operative anxiety do not end once the operation is complete. Rather, there have been suggestions that preoperative anxiety has a positive association with postoperative pain and prolonged hospital stay. Thirteen percent of pediatric surgical patients have postoperative pain that interferes with their daily activities or sleep patterns. In addition, 25-63% of pediatric patients who undergo urological surgeries experience moderate to severe pain on postoperative day 1 and the pain decreases but persists for 2 days on average. Therefore, it is worthwhile to explore noninvasive and adaptable methods to decrease preoperative anxiety among the patient and their guardians'.

Mindfulness is turning one's awareness of past and future events inward to focus on the present time. The practice provides an opportunity for people to reflect on their current internal conditions in a space and time that is not pressured, which can improve their ability to healthily and effectively respond to those conditions. One such study proposed that trait mindfulness and perceived anxiety have an inverse relationship. While another showed those with higher levels of trait mindfulness have increased resistance to stress and psychological flexibility. By embracing the entire spectrum of emotions one may encounter in the present or about a future event, people may be able to feel relief instead of increased anxiety or worry.

Вмешательства

  • Поведенческое PeSSKi questionnaire survey
    The control group will only receive the questionnaire without meditation. The PeSSKi questionnaire survey will be receive in 4 time point, First questionnaire will sent via email after the appointment for the surgery is scheduled. The second PeSSKi questionnaire survey will share via email at halfway point to the surgery. The third questionnaire survey will be done immediately before the day of surgery in person to assess how anxious the patient is. The final questionnaire survey will be done 1
  • Поведенческое Meditation Video
    The experimental group pediatric patients selected for this study and their parents will be receiving meditation and PeSSKi (Perceived Stress Scale for Kids) questionnaire. The ideal meditation schedule will be 3-5 meditations per week for 5 minutes beginning 3 weeks before surgery. This will provide a dose-response relationship of meditation to anxiety and postoperative pain for data analysis. The Patient and their parents will open the link, enter their assigned number, and follow the guided m

Первичные конечные точки

  • Preoperative Meditation may decrease preoperative anxiety among the patient and their guardians. And to see if longitudinal meditation is associated with decreased postoperative pain by examining frequency of liquid analgesic medicine intake. [Срок оценки: Active participation in the study will last for about one month, this includes three weeks pre-operatively and one week post-operatively. Total duration of the project is approximately two years.]

Критерии участия

Критерии включения

  • Age 6-18
  • Pediatric urology patients at Children's Healthcare of Georgia in Augusta, GA; scheduled for any urological surgery
  • Otherwise, healthy patients
  • Must record any medical history and medications
  • Must record prior attempts of meditation therapy
  • Children must provide assent

Критерии исключения

  • History of any prior surgeries
  • History of anxiety or anxiety-related disorders
  • Diagnosis of developmental delay

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
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • Augusta University — Augusta

Идентификаторы

NCT: NCT06858267 · 2254633

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗