Clinical trial NCT01441674: Animal Assisted Therapy in a Pediatric Setting
Official title: The Effectiveness of Animal Assisted Therapy for Children Hospitalized in a Pediatric Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Developmental Delays
Global Developmental Delay
Stroke
Cancers
Seizures Disorders
Behavior Problems
Feeding Disorder
Developmental Delay in Feeding
Keywords: Occupational Therapy
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: OT Participation scale
timeFrame: 4 days
Secondary outcomes:
measure: Vital Signs (Blood Pressure and heart rate)
timeFrame: 4 days
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Children's Hopsitals and Clinics of Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Nicole Iammatteo, OT
role: PRINCIPAL_INVESTIGATOR
References: