Animal Assisted Therapy in a Pediatric Setting

Stroke Clinical Trial

— AAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441674
• Other study ID #: AAT-IRB#1011-089
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 28, 2011
• Last updated: February 13, 2014
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Behavior Problems
• Cancers
• Developmental Delay in Feeding
• Developmental Delays
• Disease
• Epilepsy
• Feeding Disorder
• Global Developmental Delay
• Seizures Disorders
• Stroke

Intervention

Behavioral:
• Animal Assisted Therapy
There will be a therapy dog and dog trainer present working with the patient for the AAT arm.

Locations

Country	Name	City	State
United States	Children's Hopsitals and Clinics of Minnesota	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes