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AAT: Animal Assisted Therapy in a Pediatric Setting

Sponsor
Children's Hospitals and Clinics of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT01441674
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
35
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Animal Assisted Therapy
 Phase 1/Phase 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effectiveness of Animal Assisted Therapy for Children Hospitalized in a Pediatric Setting
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. OT Participation scale [4 days]

      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

    1. Vital Signs (Blood Pressure and heart rate) [4 days]

      Heart rate and blood pressure will be measured to assess if AAT minimizes stress and anxiety.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospitals and Clinics of Minnesota
    ClinicalTrials.gov Identifier:
    NCT01441674
    Other Study ID Numbers:
    • AAT-IRB#1011-089
    First Posted:
    Sep 28, 2011
    Last Update Posted:
    Feb 14, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Children's Hospitals and Clinics of Minnesota
    Occupational Therapy
    Additional relevant MeSH terms:
    Seizures
    Epilepsy
    Disease
    Problem Behavior
    Feeding and Eating Disorders

    Study Results

    No Results Posted as of Feb 14, 2014