Clinical trial NCT03017027: Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
Official title: Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Stress
Keywords: human-animal interaction
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 53
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by comparing responses between TDV and non-TDV control groups.


Eligibility criteria: Inclusion Criteria:

* understand English
* alert and oriented to person, place, and time
* able to complete study instruments
* able to provide saliva specimens, and
* consent from parent/legal guardian, and
* assent from child.

Exclusion Criteria:

* currently taking hormone replacement, or steroidal antiinflammatory medications
* in contact precautions at facility
* diagnosed with Addison's or Cushing's disease, and
* fears, phobias, or allergies to dogs.

Primary outcomes:
measure: Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale
timeFrame: immediately before session, immediately after session
measure: Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
timeFrame: immediately before session, immediately after session
measure: Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
timeFrame: immediately before session, immediately after session
measure: Change in biological stress response as assessed by salivary cortisol levels
timeFrame: immediately before session, immediately after session
measure: Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels
timeFrame: immediately before session, immediately after session
measure: Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels
timeFrame: immediately before session, immediately after session
Secondary outcomes:
measure: Attachment level to pets as assessed by the Pet Attitude Scale (PAS)
timeFrame: immediately before session
measure: Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)
timeFrame: immediately after session
measure: Human-Animal Interaction as assessed by the HAIS observer questionnaire
timeFrame: immediately after session
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sandra M Branson, PhD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References: