Animal-assisted Therapy in Pediatric Surgery: Post-operative Benefits

NCT02284100 | Completed DMC

• 1 other identifier: 20130005132
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Endocrinological impact

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

Study Arms (2)

animal assisted therapy group

EXPERIMENTAL

the dog was present during post-operative awakening (2 hours after surgery)

Behavioral: animal assisted therapy

standard group

NO INTERVENTION

children had standard post-operative medical care

Interventions

animal assisted therapy BEHAVIORAL

For the AAT session, a 7 year old Golden Retriever was employed as the therapy animal. Prior to the study, the dog underwent rigorous screening although she had previous experience in Animal Assisted Interventions and was already trained and prepared prior for this type of work. The dog was fully vaccinated, bathed regularly, screened for enteric pathogens, and treated for internal and external parasites on a monthly basis. The dog and handler met hospital policy for participating in animal-assisted therapy, including documentation of the dog's current vaccinations, controllability and temperament. The welfare of the dog was monitored and certificated by a dedicated veterinary during and at the end of the all sessions.

animal assisted therapy group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Related Publications (1)

• Calcaterra V, Veggiotti P, Palestrini C, De Giorgis V, Raschetti R, Tumminelli M, Mencherini S, Papotti F, Klersy C, Albertini R, Ostuni S, Pelizzo G. Post-operative benefits of animal-assisted therapy in pediatric surgery: a randomised study. PLoS One. 2015 Jun 3;10(6):e0125813. doi: 10.1371/journal.pone.0125813. eCollection 2015.

  PMID: 26039494 DERIVED

MeSH Terms

Interventions

Animal Assisted Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gloria Pelizzo, Prof

  Fondazione IRCCS Policlinico S. Matteo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 5, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 6, 2014

Record last verified: 2014-11