Ignite Creation Date:
2024-05-06 @ 3:24 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02284100
Status:
COMPLETED
Last Update Posted:
2014-11-06
First Post:
2014-10-29
Brief Title:
Animal-assisted Therapy in Pediatric Surgery Post-operative Benefits
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
Official Title:
Animal-assisted Therapy in Pediatric Surgery Cardiovascular Neurological and Endocrinological Responses to Stress and Pain in the Immediate Post-operative Period
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 childs 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
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 childs 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
Detailed Description:
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 patients 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 childs 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 childs 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 alpha010 pilot study using a 2-tailed test to detect an effect size of 08 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-value005 was considered statistically significant All statistical analyses were performed using Stata 131 StataCorp College Station Texas USA
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 patients 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 childs 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 childs 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 alpha010 pilot study using a 2-tailed test to detect an effect size of 08 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-value005 was considered statistically significant All statistical analyses were performed using Stata 131 StataCorp College Station Texas USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None