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

Study Overview
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Brief Summary
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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.

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

Conditions
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Psychosocial Stress

Intervention / Treatment
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* Behavioral: Therapy dog visitation (TDV)
* Behavioral: non-TDV control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy dog visitation (TDV)<br>The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted. | Behavioral: Therapy dog visitation (TDV)<br>* The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.<br>|
| Other: non-TDV control<br>Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep. | Behavioral: non-TDV control<br>* Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale | 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. | immediately before session, immediately after session | 
| Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C) | 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. | immediately before session, immediately after session | 
| Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C) | 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. | immediately before session, immediately after session | 
| Change in biological stress response as assessed by salivary cortisol levels | 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. | immediately before session, immediately after session | 
| Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels | 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. | immediately before session, immediately after session | 
| Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels | 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. | immediately before session, immediately after session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attachment level to pets as assessed by the Pet Attitude Scale (PAS) | Attachment to pets will be measured using the Pet Attitude Scale (PAS)Questionnaire.The PAS is an 18 item paper and pencil instrument with 7 Likert response statements which measures the favorableness of attitudes towards pets. Higher scores indicate more positive attitudes towards pets. Evidence of PAS-M is demonstrated with a Cronbach's alpha of .93. | immediately before session | 
| Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS) | The Human-Animal Interaction Scale (HAIS) is a newly developed questionnaire designed to measure behavioral interactions between animal and human which predict beneficial effects to humans (Fournier, Letson, Laitalia, & Krog, 2015). The HAIS is a 26 item Likert Scale with 5 Likert response statements ranging from not at all to a great deal and is completed by the participant after the TDV. | immediately after session | 
| Human-Animal Interaction as assessed by the HAIS observer questionnaire | The HAIS observer questionnaire is a 24 item instrument completed by the research staff who quantifies behaviors with a percent or range in respect to the behavior observed. | immediately after session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human-animal interaction