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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 50 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Psychosocial Stress

Being tested

Therapy dog visitation

Keywords

human-animal interaction

Medical subject headings

Human-Animal Interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Therapy dog visitationBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: immediately before TDV, immediately after TDV

2. 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.

   Measured: immediately before TDV, immediately after TDV

3. 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).

   Measured: immediately before TDV, immediately after TDV

4. 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.

   Measured: immediately before TDV, immediately after TDV

5. 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.

   Measured: immediately before TDV, immediately after TDV

6. 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.

   Measured: immediately before TDV, immediately after TDV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted20 Dec 2016 (estimated)
2. Study start25 Jul 2016
3. Primary completion26 Feb 2018
4. Study completion26 Feb 2018

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Psychosocial StressStudies of the same condition, open and under way.
• More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.