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
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.
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.
As outcome measures the investigators considered:
- for neurological impact, the difference in the prevalence of beta (>14 Hz)
electroencephalogram (EEG) activity between intervention and control group (20-23);
- for autonomic impact, the difference in blood pressure (BP) between intervention and
control group;
- for cardiac impact, the difference in heart rate (HR) between intervention and control
group;
- for respiratory impact, the difference in oxygen saturation (SpO2) between intervention
and control group;
- for cerebral oxygenation, the difference in prefrontal oxygenation (HbO2) with
near-infrared spectroscopy (NIRS) between intervention and control group;
- for endocrinological impact, the difference in salivary cortisol levels, between
intervention and control group. The Wong-Baker Faces pain scale (FPS) was used to
measure the child's self-reported pain.
At admission, auxological examination of the children included measurement of height, weight
and body mass index. Height measurement was performed with patients in an upright position,
without shoes, with their heels together, arms extended down the sides of the body and head
positioned parallel to the floor. Weight was measured with the children barefooted and
wearing light clothes, standing upright in the centre of the scale platform with their arms
extended down the sides of the body. BMI was calculated as body weight in kilograms divided
by body height squared in meters.
EEG activity, cerebral prefrontal oxygenation, heart rate, blood pressure, oxygen
saturation, salivary cortisol levels, faces pain scale were considered as indicators of
neurological, cardiovascular and endocrinological response to stress and pain.
Data collection was performed in the following phases:
- for all parameters, post-operatively baseline (T1), two hours after surgery at
re-admission to the Unit. Pre dog-intervention in the AAT-group;
- for all parameters, in the twenty minutes following T1 (T2). During the
dog-intervention in the AAT-group. For the STAND-group, the child was asked to sit
quietly;
- only for salivary cortisol levels, between 11 pm and midnight (T3, the time when
cortisol is normally at its lowest)
Vitals signs
HR, BP, SpO2, HbO2 were monitored (Dräger Primus ®) and recorded as follows:
- T1 (every 5 minutes, for 10 minutes. Mean values were used for the statistical
analysis);
- T2 (every 5 minutes, for 20 minutes. Mean values were used for the statistical
analysis).
Endocrinological parameters Salivary cortisol levels were measured at T1, after T2 and T3.
The saliva samples were collected using a standardized salivette and frozen at -20° until
analysis in the laboratory. After thawing, salivary fluids were centrifugated to precipitate
mucins and cortisol was assayed in the supernatant with a solid-phase radioimmunoassay,
wherein 125-I labeled cortisol competes for a fixed time with cortisol in the biological
sample (The Coat-A-Count Cortisol, Siemens, Los Angeles, CA).
Pain response The faces pain scale was used to measure the child's self-reported pain at T1
and at the end of T2. This scale consisted of 6 cartoon faces with varying expressions
ranging from very happy to very sad. The child rated the pain intensity on a scale, with
point 0 being no pain and point 10 being the worst pain.
Analgesic treatment in the first 12 hours post-intervention was recorded.
Electroencephalogram Regarding the AAT-group patients, an EEG recording was obtained when
the child was awake, 2 hours after surgery and before and during AAT intervention. In the
STAND-group patients, and EEG recording was made 2 hours after surgery.
Any change in the normal physiological structure of the EEG, correlating the effect of the
anaesthesia, post-operative stress of AAT intervention was recorded and monitored.
In both cases, the protocol included an EEG recording tasting about 20 minutes, while awake,
with open and closed eyes.
Parental permission was obtained through a written and oral informed consent. Written assent
by the patient was also obtained in children eight years of age and older before enrolment.
Statistical analysis A desired sample size of 20 patients per group for a total of 40
subjects was determined based on 80% power alpha=0.10 (pilot study), using a 2-tailed test,
to detect an effect size of 0.8 for the primary endpoint measured on a continuous scale, and
an absolute difference in prevalence of the primary endpoint of 31 to 34% for the expected
prevalence in the control group of 5 and 10% respectively.
Continuous variables were described as the mean and standard deviation (SD) or median and
quartiles and categorical variables as counts and percentages. The prevalence of EEG beta
activity was compared with the Fisher exact test. To test the effects of AAT on vital signs
and on endocrinological parameters over time in the two groups, regression models for
repeated measures were used, including a main effect for group and time, as well as their
interaction. Distribution of pain scores at the end of the session in the two groups was
compared with the Fisher exact test. A 2-sided p-value<0.05 was considered statistically
significant. All statistical analyses were performed using Stata 13.1 (StataCorp, College
Station, Texas, USA).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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