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

NCT02997852 | Completed

• 1 other identifier: HSC-SN-15-0169
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosocial Stress

Keywords

human-animal interaction

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Attachment level to pets as assessed by the Pet Attitude Scale (PAS)

  immediately before TDV

• Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)

  immediately after TDV

• Human-Animal Interaction as assessed by the HAIS observer questionnaire

  immediately after TDV

Study Arms (2)

Therapy dog visitation

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care in the intensive care unit.

Interventions

Therapy dog visitation BEHAVIORAL

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.

Therapy dog visitation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years old
• able to provide consent and understand English
• able to complete study instruments

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Human-Animal Interaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sandra M Branson, PhD, MSN, RN

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 20, 2016
• Study Start: July 25, 2016
• Primary Completion: February 26, 2018
• Study Completion: February 26, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

US (1)