Biobehavioral Effects of Therapy Dog Visitation in Elderly Intensive Care Unit Patients: A Pilot and Feasibility Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses.

Official Title
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Biobehavioral Effects of Therapy Dog Visitation in Elderly Intensive Care Unit Patients: A Pilot and Feasibility Study

Conditions
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Psychosocial Stress

Intervention / Treatment
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* Behavioral: Therapy dog visitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥50 years old able to provide consent and understand English able to complete study instruments Exclusion Criteria: currently taking hormone replacement or steroidal anti-inflammatory medications, in contact precautions at facility, diagnosed with Addison's or Cushing's disease fears or phobias to dogs, or allergies to dogs.

Ages Eligible for Study
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Minimum Age: 50 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<br>The TDV will consist of a 10-minute visit from the same Faithful Paws animal handler and her dog. Each therapy dog meets obedience, temperament, and health standards appropriate to therapy dog visitation in hospital settings. The dog will be leashed and under control of the animal handler and the TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Visual and tactile contact with the dog will be promoted by the animal handler. Per hospital protocol, the patient will be assisted in washing his/her hands before and after the TDV and the dog will be placed on the bed or remain at the bedside in close proximity allowing petting. A clean sheet will be placed over the patient when the dog is placed on the bed. The research staff will collect data before and after each arm of the study. | Behavioral: Therapy dog visitation<br>* The TDV will consist of a 10-minute visit from the same Faithful Paws animal handler and her dog. Each therapy dog meets obedience, temperament, and health standards appropriate to therapy dog visitation in hospital settings. The dog will be leashed and under control of the animal handler and the TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Visual and tactile contact with the dog will be promoted by the animal handler. Per hospital protocol, the patient will be assisted in washing his/her hands before and after the TDV and the dog will be placed on the bed or remain at the bedside in close proximity allowing petting. A clean sheet will be placed over the patient when the dog is placed on the bed. The research staff will collect data before and after each arm of the study.<br>|
| No Intervention: Control<br>Usual care in the intensive care unit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in stress as assessed by the Stress-Visual Analog Scale | Stress will be measured using the Stress-Visual Analog Scale which is a tool used in intensive care unit (ICU) settings that consists of a small, unmarked 100mm ruler with endpoints labeled none and as bad as it could be. Participants indicate how stressed they feel on the ruler, which yields a single subjective stress score between 0 and 100. The Stress visual analogue scale (VAS) demonstrates acceptable validity between the VAS and the Hospital Anxiety and Depression (HADS) total score with correlations of r = 0.65. | immediately before TDV, immediately after TDV | 
| Change in Anxiety as assessed by the Faces Anxiety Scale | Anxiety will be measured using the FACES Anxiety Scale, a brief single-item, five-point self-report scale commonly used in the ICU consisting of 5 faces representing an increased level of anxiety, where the first item represents a no anxiety face (Elkman & Friesen; 1975). The FACES Anxiety Scale is a commonly used instrument in the ICU and proposed by the American Association of Critical-Care Nurses and demonstrates acceptable criterion validity between the FACES Anxiety Scale and State Anxiety Inventory total score in ventilated and non-ventilated ICU patients with correlations of r =.70; p<0005. | immediately before TDV, immediately after TDV | 
| Change in Mood as assessed by the Positive and Negative Affect Schedule | Measures for mood (positive/negative affect) will be measured using the Positive and Negative Affect Schedule (PANAS). The PANAS is an established 20-item instrument that uses a 5-point Likert scale and includes single words that express negative and positive moods. The instructions on the instrument would be revised to state, indicate how you feel right now rather than indicate how you felt in the last week. Sample answers include excited, scared, nervous, and enthusiastic, etc. (Craword & Henry, 2004). | immediately before TDV, immediately after TDV | 
| Change in biological stress response as assessed by salivary cortisol levels | Saliva samples will be assayed using standardized enzyme immunoassay (EIA) kits (Salimetrics, State Park: PA). For cortisol, intra-assay coefficient of variation (CV) ranges between 4%-7% and inter-assay CV ranges between 3%-11%. Sensitivity of the EIA kit is .0007 μg/mL. | immediately before TDV, immediately after TDV | 
| Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels | Saliva samples will be assayed using standardized enzyme immunoassay (EIA) kits (Salimetrics, State Park: PA). For CRP, intra-assay CV ranges between 1.9%-5.9% and inter-assay CV ranges between 3.7%-11.2%. Sensitivity of the EIA kit is 10 pg/mL. | immediately before TDV, immediately after TDV | 
| Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels | Saliva samples will be assayed using standardized enzyme immunoassay (EIA) kits (Salimetrics, State Park: PA). For IL-1β, intra-assay CV ranges between 2-3% and inter-assay CV is 4.5%. Sensitivity of the EIA kit is 0.6 pg/mL. | immediately before TDV, immediately after TDV | 

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 considered a reliable instrument in the elderly with a Cronbach's alpha of 0.73. | immediately before TDV | 
| 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 TDV | 
| 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 TDV | 

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