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Набор скоро начнётся NCT07349667

Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting

Без фазы С лечением Arthritis, Juvenile Arthritis, Juvenile Idiopathic Lupus Erythematosus, Systemic Dermatomyositis, Juvenile

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: Hypnotherapy.
Кому может быть актуально
Состояния в реестре: Arthritis, Juvenile, Arthritis, Juvenile Idiopathic, Lupus Erythematosus, Systemic, Dermatomyositis, Juvenile. 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
Дания
Следующий шаг
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Официальное название

Hypnotherapy for Needle-related Procedural Pain and Anxiety Management in a Pediatric Setting: A Randomized Controlled Trial

Обзор

The proposed study aims to evaluate the effectiveness of hypnotherapy as a non-pharmacological intervention for managing pain and anxiety during needle-related medical procedures in children aged 5 to 17 years. This research addresses a significant gap in pediatric healthcare, where painful procedures often induce distress and long-term anxiety, leading to avoidance of necessary medical care. Conventional pain management strategies primarily rely on pharmacological methods, which may pose risks and side effects. Thus, exploring safe and effective alternatives, such as hypnotherapy, is crucial.The target group for this randomized controlled trial includes children scheduled for painful procedures, such as injections or blood sampling. Participants will be randomly assigned to either the hypnotherapy group, receiving tailored sessions conducted by trained hypnotherapists, or the standard of care group, which will involve conventional pain management techniques. The study will assess primary outcomes, including anxiety levels and pain perception, before, during, and after the procedures using validated scales. Key activities of the project include conducting individualized hypnotherapy sessions, monitoring anxiety and pain levels through structured assessments, and analyzing the data to determine the effectiveness and feasibility of hypnotherapy. Secondary objectives will explore potential long-term benefits and safety concerns associated with hypnotherapy. If successful, this study could significantly enhance pediatric pain management practices, reduce reliance on pharmacological interventions, and improve the overall healthcare experience for children. The findings may also inform broader healthcare policies regarding non-pharmacological pain management strategies in pediatric settings.

Вмешательства

  • Другое Hypnotherapy
    The hypnotherapy session will be individualized to the particular child. The nurse performing the hypnotherapy session will ask the child a few basic questions about his/her favorite place or activity. If the child do not have any suggestions the nurse will suggest an age-appropriate activity to daydream about, such as making a snowman for a six year-old or skiing for an adolescent, and then suggest a hypnotic "daydream" about that place or activity. Most inductions for older children (ages appr

Первичные конечные точки

  • Level of anxiety before, during and after the medical procedure and pain intensity before, during and after the medical procedure. [Срок оценки: pre-procedure, periprocedurally and immediately after the procedure]
Вторичные конечные точки (4)
  • Generalized anxiety. [Срок оценки: Immediately after the procedure]
  • Adverse events related to hypnotherapy [Срок оценки: Immediately after the procedure]
  • The time spend on the total procedure [Срок оценки: from start to end of procedure]
  • Heartrate [Срок оценки: pre-procedure, periprocedurally and immediately after the procedure]

Критерии участия

Критерии включения

  • Children aged 6 to 18 years
  • Scheduled for a painful medical procedure (injections or blood sampling)
  • Informed consent obtained from parents or legal guardians

Критерии исключения

  • Children with a history of psychiatric disorders or cognitive impairment
  • Children unable to understand and participate in hypnotherapy sessions
  • Any contraindication to hypnotherapy
  • Children with diagnosed cancer

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
Организация здравоохранения

Центры проведения

Дания · 1 центр
  • Aarhus University Hospital — Aarhus

Идентификаторы

NCT: NCT07349667 · 0097327

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗