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Clinical Trials/NCT03017027
NCT03017027
Completed
N/A

Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial

The University of Texas Health Science Center, Houston1 site in 1 country53 target enrollmentMarch 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosocial Stress
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
53
Locations
1
Primary Endpoint
Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2015
End Date
January 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sandra M Branson

Assistant Professor

The University of Texas Health Science Center, Houston

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.

Outcomes

Primary Outcomes

Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale

Time Frame: immediately before session, immediately after session

State anxiety will be measured using the State Anxiety Inventory for Children (STAI-C), a widely used instrument with upper elementary or junior high school aged children. The instrument is composed of 20 statements that ask about how one feels at a particular moment in time with three responses from "very to not". Scores range from 20 to 80 and higher scores indicate a higher state of anxiety. Internal consistency has been demonstrated; researchers have reported acceptable reliability coefficients in hospitalized children ages 7-11 years old with Cronbach's α of .94.

Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)

Time Frame: immediately before session, immediately after session

The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely"). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.

Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)

Time Frame: immediately before session, immediately after session

The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely"). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.

Change in biological stress response as assessed by salivary cortisol levels

Time Frame: immediately before session, immediately after session

Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.

Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels

Time Frame: immediately before session, immediately after session

Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.

Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels

Time Frame: immediately before session, immediately after session

Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.

Secondary Outcomes

  • Attachment level to pets as assessed by the Pet Attitude Scale (PAS)(immediately before session)
  • Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)(immediately after session)
  • Human-Animal Interaction as assessed by the HAIS observer questionnaire(immediately after session)

Study Sites (1)

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