Surgery Clinical Trial
Official title:
Animal-assisted Therapy in Pediatric Surgery: Cardiovascular, Neurological and Endocrinological Responses to Stress and Pain in the Immediate Post-operative Period
Verified date | November 2014 |
Source | IRCCS Policlinico S. Matteo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 17 Years |
Eligibility |
Inclusion Criteria: - immunocompetent children (both genders) - aged 3 to 17 years - undergoing surgical procedures (including orchidopexy, inguinal or umbilical hernia repair, circumcision, varicocele treatment) Exclusion Criteria: - allergy or fear of dogs - previous AAT experience - immunodeficiency - chronic illness - obesity and use of any medications. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
IRCCS Policlinico S. Matteo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Endocrinological impact | Endocrinological impact assessed by the difference in salivary cortisol levels between intervention and control group. | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
Primary | Neurological impact | Neurological impact assessed by the difference in prevalence of beta (>14 Hz) electroencephalogram (EEG) activity between intervention and control group. | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
Secondary | Autonomic impact | Autonomic impact assessed by the difference in blood pressure (BP) between intervention and control group | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
Secondary | Cardiac impact | Cardiac impact assessed by the difference in heart rate between intervention and control group | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
Secondary | Respiratory impact | Respiratory impact assessed by the difference in oxygen saturation (SpO2) between intervention and control group | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
Secondary | Cerebral oxygenation | Cerebral oxygenation assessed by the difference in prefrontal oxygenation (HbO2) between intervention and control group | Partecipants will be followed for the duration of immediate postoperative period, an expected average of 4 hours | No |
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