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Clinical Trials/NCT02997852
NCT02997852
Completed
N/A

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

The University of Texas Health Science Center, Houston1 site in 1 country15 target enrollmentJuly 25, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychosocial Stress
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
15
Locations
1
Primary Endpoint
Change in stress as assessed by the Stress-Visual Analog Scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 25, 2016
End Date
February 26, 2018
Last Updated
7 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

  • ≥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.

Outcomes

Primary Outcomes

Change in stress as assessed by the Stress-Visual Analog Scale

Time Frame: immediately before TDV, immediately after TDV

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.

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

Time Frame: immediately before TDV, immediately after TDV

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.

Change in biological stress response as assessed by salivary cortisol levels

Time Frame: immediately before TDV, immediately after TDV

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.

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

Time Frame: immediately before TDV, immediately after TDV

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.

Change in Anxiety as assessed by the Faces Anxiety Scale

Time Frame: immediately before TDV, immediately after TDV

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.

Change in Mood as assessed by the Positive and Negative Affect Schedule

Time Frame: immediately before TDV, immediately after TDV

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).

Secondary Outcomes

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

Study Sites (1)

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