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临床试验/NCT02284100
NCT02284100已完成不适用

Animal-assisted Therapy in Pediatric Surgery: Cardiovascular, Neurological and Endocrinological Responses to Stress and Pain in the Immediate Post-operative Period

Fondazione IRCCS Policlinico San Matteo di Pavia0 个研究点目标入组 40 人开始时间: 2013年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Neurological impact

研究概览

简要总结

The relationship between human beings and animals, especially dogs, has existed for thousands of years. Historically, animals have held an important role in this relationship as they provide company, stimulus and motivation. Animals are excellent company, since their visitation they do not discriminate or segregate any person, that is, they are free of prejudice.

In spite of the long-lasting presence of companion animals in human life, the idea that interaction with animals may exert a positive effect on human health is rather recent.

The American Veterinary Medical Association classifies therapeutic animal assisted interventions (AAI) into three categories: animal assisted activities (AAA) that utilize companion animals; animal assisted therapy (AAT) that utilizes therapy animals and service animal programs (SAP) that utilize service animals. AAT in particular, is a goal-directed intervention in which an animal that meets specific criteria is an integral part of the treatment process. AAT is technically defined as the use of trained animals by trained health professionals to facilitate specific, measurable goals for individual patients for whom there is documentation of progress .

Interest in AAT has been fueled by studies supporting the many health benefits. AAT has proven a useful adjunct in a variety of settings including mental health facilities, nursing homes and hospitals where most studies have been performed with adult patients with variable interventions, goals, patient characteristic and patient needs. In these studies, AAT resulted in significant reductions in anxiety, agitation and fear. In children, AAT dogs decreased distress during painful medical procedures, promoted calmness in children with post-traumatic stress disorders and increased attention and positive behaviors in children with pervasive developmental disorders.

Surgical procedures and hospitalization can be stressful for both children and their parents and they are associated with pain, helplessness, fear and boredom. AAT has been shown to facilitate a child's ability to cope with hospitalization, but to date, no studies on AAT benefits in pediatric surgery have been reported.

The purpose of this study was to better understand the effects of an AAT program on neurological, cardiovascular and endocrinological responses to stress and pain in the immediate post-operative period in children undergoing surgical procedures.

详细描述

Interest in animal-assisted therapy has been fueled by studies supporting the many health benefits in the adult and pediatric age. The purpose of this study was to study the impact of an AAT program on cardiovascular, neurological and endocrinological responses to stress and pain in the immediate post-operative period following pediatric surgery.

Forty immunocompetent children undergoing surgical procedures (including orchidopexy, inguinal or umbilical hernia repair, circumcision, varicocele treatment) were sequentially enrolled.

This was a randomised open-label, controlled, pilot study. The different arms consisted of an experimental group with a AAT session after a surgical procedure and a control group with standard care after surgery.

The study variables were determined in each patient independently of the assigned group, before and after the experimental intervention, by a researcher unblinded to the patient's group.

The outcomes of the study were to define the impact of AAT on neurological, cardiovascular and endocrinological signs, in response to stress and pain in children undergoing surgical procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • immunocompetent children (both genders)
  • aged 3 to 17 years
  • undergoing surgical procedures (including orchidopexy, inguinal or umbilical hernia repair, circumcision, varicocele treatment)

排除标准

  • allergy or fear of dogs
  • previous AAT experience
  • immunodeficiency
  • chronic illness
  • obesity and use of any medications.

结局指标

主要结局

Neurological impact

时间窗: Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours

Neurological impact assessed by the difference in prevalence of beta (\>14 Hz) electroencephalogram (EEG) activity between intervention and control group.

次要结局

  • Autonomic impact(Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours)
  • Cardiac impact(Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours)
  • Respiratory impact(Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours)
  • Cerebral oxygenation(Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pelizzo Gloria

Professor

Fondazione IRCCS Policlinico San Matteo di Pavia

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