Animal Assisted Therapy in a Pediatric Setting (AAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier:
NCT01441674
First received: January 28, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Developmental Delays
Global Developmental Delay
Stroke
Cancers
Seizures Disorders
Behavior Problems
Feeding Disorder
Developmental Delay in Feeding
Behavioral: Animal Assisted Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Animal Assisted Therapy for Children Hospitalized in a Pediatric Setting

Resource links provided by NLM:


Further study details as provided by Children's Hospitals and Clinics of Minnesota:

Primary Outcome Measures:
  • OT Participation scale [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Vital Signs (Blood Pressure and heart rate) [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
    Heart rate and blood pressure will be measured to assess if AAT minimizes stress and anxiety.


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Group 1 and Group 2

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441674

Locations
United States, Minnesota
Children's Hopsitals and Clinics of Minnesota
St. Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Children's Hospitals and Clinics of Minnesota
Investigators
Principal Investigator: Nicole Iammatteo, OT Children's Hospitals and Clinics of Minnesota
  More Information

No publications provided

Responsible Party: Children's Hospitals and Clinics of Minnesota
ClinicalTrials.gov Identifier: NCT01441674     History of Changes
Other Study ID Numbers: AAT-IRB#1011-089
Study First Received: January 28, 2011
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospitals and Clinics of Minnesota:
Occupational Therapy

Additional relevant MeSH terms:
Disease
Epilepsy
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 01, 2014