Animal Assisted Therapy in a Pediatric Setting (AAT)

The Effectiveness of Animal Assisted Therapy for Children Hospitalized in a Pediatric Setting

The primary purpose for this study is to determine if children who receive Occupational Therapy while they are an inpatient in the hospital will be more motivated to participate in therapy as well as increase the amount of time they will work during that particular session when a therapy dog is present during their sessions. The investigators will also be collecting data regarding a child's heart rate and blood pressure prior to the session starting and ending to determine if having a therapy dog present also helps relax a child.

Study Overview

• Status: Completed
• Conditions: Stroke; Behavior Problems; Feeding Disorder; Developmental Delays; Cancers; Global Developmental Delay; Seizures Disorders; Developmental Delay in Feeding
• Intervention / Treatment: Behavioral: Animal Assisted Therapy

Detailed Description

The primary objective of this study is to evaluate if a patient in the pediatric acute care setting receiving Occupational Therapy (OT) services in adjunct with animal assisted therapy (AAT) are more motivated to actively participate in the therapy session for a longer period of time.

Methods:

Thirty inpatients will be recruited to participate in this study. This study will utilize a randomized crossover study design where the patients act as their own control. The treatment period for hospitalized patients will include an on off pattern of incorporating AAT into their OT session. Patients' participation of therapy will be assessed with a participation scale (see Figure 2) and the OT session time. Patients will be evaluated for OT and the therapist will determine goals based on functional status and needs of the particular patient. Goals will be determined by providing a functional evaluation based upon Occupational Therapists clinical observation, developmental standards and current functional level of the patient.

Patients who are potential candidates for this study will be hospitalized at Children's Hospitals and Clinics of Minnesota on the St. Paul campus. All inpatients stated to have decreased functional skills that have been referred by a physician to OT will be invited to participate this study.

Patients have a difficult time participating in various therapies due to emotional stress, anxiety, and feeling uncomfortable with the hospital environment. Limited studies have demonstrated the value of AAT used in conjunction with OT for children, regardless of diagnosis within the hospital setting. Results of this study can justify the use of this valuable therapy not only for the selected population, but also for other disciplines such as physical and speech therapy.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • St. Paul, Minnesota, United States, 55102
      • Children's Hopsitals and Clinics of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inpatient Occupational Therapy Referrals
• Ages 0-21 years

Exclusion Criteria:

• Patients who are uncomfortable with dogs
• Patients who exhibits violent behavior
• Animal Allergies
• Patients are unable to work with a dog
• Patients who exhibit severe cognitive delays

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Animal Assisted Therapy Visit 1; Standard OT Therapy with Animal Assisted Therapy at Visit 1 and Not at Visit 2	Behavioral: Animal Assisted Therapy; There will be a therapy dog and dog trainer present working with the patient for the AAT arm.; Other Names: Group 1 and Group 2
Experimental: Animal Assisted Therapy at Visit 2; Standard OT Therapy with Animal Assisted Therapy at Visit 2 and not Visit 1	Behavioral: Animal Assisted Therapy; There will be a therapy dog and dog trainer present working with the patient for the AAT arm.; Other Names: Group 1 and Group 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OT Participation scale	The patients response to therapy can be measures using the following behavior domains (cognition, fine motor, activities and daily living, feeding skills, active range of motion/activities, and functional Transfers).	4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs (Blood Pressure and heart rate)	Heart rate and blood pressure will be measured to assess if AAT minimizes stress and anxiety.	4 days

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota
• Investigators: Principal Investigator: Nicole Iammatteo, OT, Children's Hospitals and Clinics of Minnesota

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 14, 2014
• Last Update Submitted That Met QC Criteria: February 13, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Occupational Therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Disease; Problem Behavior; Feeding and Eating Disorders; Seizures
• Other Study ID Numbers: AAT-IRB#1011-089