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Идёт набор NCT06468111

Dog-Assisted Therapy in Children During Blood or Dental Extraction.

Без фазы С лечением Emotional Stress

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: Animal Assisted Therapy.
Кому может быть актуально
Состояния в реестре: Emotional Stress. Базовые параметры: 3 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
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Efficacy Study of Dog-Assisted Therapy in Children During Blood or Dental Extraction: Extra-can Project

Обзор

The purpose of the present study is to evaluate the efficacy of Animal Assisted Therapy (AAT) during blood extraction or dental procedures in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member. These objectives will be accomplished through a randomized open label two-arm controlled study of AAT for children who need a blood or dental extraction.

Подробное описание

INTRODUCTION: Venous puncture for routine blood sampling can be distressing for many children, leading to heightened anxiety both before and during the procedure. Dental anxiety affects around 9% of European children and adolescents, potentially persisting into adulthood and resulting in dental avoidance behaviors. Animal-assisted therapy (AAT) is viewed as a distraction technique that could play a vital role in managing pain and distress for children. AAT is a planned, structured therapeutic intervention with specific goals, facilitated by healthcare professionals.

OBJECTIVES: Evaluate the efficacy of AAT during blood or dental extraction in a Primary Care Pediatric Service. Determine the improvement in facilitating the task of venipuncture or dental extraction for nursing or dental professionals. Estimate the reduction in the child's emotional stress during these procedures with the support of a therapy dog. Evaluate the emotional stress in the accompanying family member.

METHODOLOGY: Randomized two-arm clinical trial (control group and intervention group) involving children aged 3 to 8 requiring blood analysis or dental extraction in a Primary Health Care Center. Patients will be randomly assigned to the control and intervention groups. Sample size calculations suggest 60 patients in each group to detect statistically significant differences. The control group follows standard protocols, while the intervention group includes AAT with 10 minutes of pre-procedure interaction with the therapy dog, extraction performed with the therapy dog, and 5 minutes of post-procedure interaction. Personnel includes nurses or dentists, a pediatrician, and an AAT technician. Response variables include various scales measuring anxiety and distress, while control variables encompass age, gender, pathologies, extraction type, and pet ownership.

EXPECTED RESULTS: The implementation of AAT as an emotional support intervention, utilizing a therapy dog for distraction, is anticipated to improve symptomatology in the intervention group by reducing fear and anxiety post-procedure.

Вмешательства

  • Поведенческое Animal Assisted Therapy
    Blood and dental extraction will be performed according to the usual protocol of the health center in both groups; with the additional assistance of the therapy dog in experimental group.

Первичные конечные точки

  • Observation Scale of Behavioral Distress (OSBD) registered at baseline, during and immediately after the intervention [Срок оценки: This scale registered behaviors in continuous 15-second intervals at baseline, during and immediately after the intervention]
Вторичные конечные точки (2)
  • State-Trait Anxiety Inventory Questionnaire (STAI) registered at baseline and immediately after the intervention [Срок оценки: This questionnaire will be administered at baseline and immediately after the intervention, post-extraction.]
  • Wong-Baker Faces Scale registered at baseline and immediately after the intervention [Срок оценки: This scale will be administered at baseline and immediately after the intervention, post-extraction.]

Критерии участия

Критерии включения

  • Age between 3 and 12 years old.
  • Need a blood or dental extraction.
  • Willing to participate in the study on a voluntary basis.
  • Delivery of the information sheet and signature the informed consent.

Критерии исключения

  • If in the initial interview they declared having allergy or fear of dogs.
  • Have aggression disorder towards dogs.
  • Not want to participate in the study.

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

Испания · 1 центр
  • Centre d'Atenció Primària Primer de Maig — Lleida

Идентификаторы

NCT: NCT06468111 · DMP ID: 2163

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗