- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997852
Biobehavioral Effects of Therapy Dog Visitation in Elderly Intensive Care Unit Patients: A Pilot and Feasibility Study
November 1, 2018 updated by: Sandra M Branson, The University of Texas Health Science Center, Houston
The purpose of this study is to assess the preliminary efficacy of a 10-minute therapy dog visitation (TDV) in reducing biobehavioral stress responses.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Therapy dog visitation
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.
|
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.
|
No Intervention: Control
Usual care in the intensive care unit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately before TDV, immediately after TDV
|
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.
|
immediately before TDV, immediately after TDV
|
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).
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immediately before TDV, immediately after TDV
|
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.
|
immediately before TDV, immediately after TDV
|
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.
|
immediately before TDV, immediately after TDV
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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.
|
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)
Time Frame: immediately before TDV
|
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)
Time Frame: immediately after TDV
|
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.
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immediately after TDV
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Human-Animal Interaction as assessed by the HAIS observer questionnaire
Time Frame: immediately after TDV
|
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.
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immediately after TDV
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sandra M Branson, PhD, MSN, RN, The University of Texas Health Science Center, Houston
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2016
Primary Completion (Actual)
February 26, 2018
Study Completion (Actual)
February 26, 2018
Study Registration Dates
First Submitted
December 15, 2016
First Submitted That Met QC Criteria
December 15, 2016
First Posted (Estimate)
December 20, 2016
Study Record Updates
Last Update Posted (Actual)
November 5, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SN-15-0169
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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