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Completed

NCT Number: NCT02997852

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

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • The Methodist Hospital Research Institute

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2016
Registry last updated
Nov 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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