Animal-Assisted Therapy for Hospitalized Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Animal-assisted Therapy
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring animal-assisted therapy, dog hospital visit, heart failure
Eligibility Criteria
Inclusion Criteria:
- diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
- age between 18 and 80 years
- ability to read, write, and speak English
- mental status: alert and oriented to person, place, and time
- SVR greater than 1200 dyne · sec · cm-5 at least once within 12 hours from the start of data collection
Exclusion Criteria:
- SVR less than 1200 dyne · sec · cm-5
- allergies to dogs
- immunosuppression, defined as a white blood cell count of less than 4500 cells/mm3
- infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm3
- body temperature greater than 38ºC
- decreased level of consciousness
Sites / Locations
- UCLA Medical Center
Outcomes
Primary Outcome Measures
Blood pressure
heart rate
pulmonary artery pressure
pulmonary capillary wedge pressure
right atrial pressure
cardiac index
systemic vascular resistance
plasma levels of epinephrine
plasma levels of norepinephrine
state anxiety
Secondary Outcome Measures
Full Information
NCT ID
NCT00391456
First Posted
October 23, 2006
Last Updated
June 1, 2016
Sponsor
University of California, Los Angeles
Collaborators
Pet Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT00391456
Brief Title
Animal-Assisted Therapy for Hospitalized Heart Failure Patients
Official Title
Use of Animal-Assisted Therapy to Decrease Cardiopulmonary Pressures, Neurohormone Levels, and State Anxiety in Patients Hospitalized With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of California, Los Angeles
Collaborators
Pet Care Trust
4. Oversight
5. Study Description
Brief Summary
Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
The purpose of this study was to determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Detailed Description
Context: Effects of complementary therapies on heart failure, a leading cause of hospitalization, are unknown. Animal-assisted therapy improves physiological and psychosocial variables in healthy and hypertensive subjects.
Objectives: To determine whether a 12-minute hospital visit with a therapy dog improves hemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalized with heart failure.
Design, Setting, Participants: A 3-group (volunteer-dog team, volunteer only, and control) randomized repeated-measures experimental design was used in 76 adult patients with advanced heart failure hospitalized between November 2001 and July 2004. Longitudinal analysis was used to model differences among the 3 groups at 3 time points.
Interventions: One group received a 12-minute visit from a volunteer with a therapy dog, another group received a 12-minute visit from a volunteer, and the control group received usual care, at rest. Data were collected at baseline, 8 minutes after the intervention started, and 16 minutes (4 minutes after intervention ended).
Main Outcome Measures: Blood pressure, heart rate, pulmonary artery pressure, pulmonary capillary wedge pressure, right atrial pressure, cardiac index, systemic vascular resistance, plasma levels of epinephrine and norepinephrine, and state anxiety.
Results: Compared with the control group, patients visited by a volunteer-dog team showed significantly greater decreases in pulmonary artery pressure during (5.34, P = .003) and after (5.78, P = .001) the intervention, pulmonary capillary wedge pressure during (3.09, P = .02) and after (4.31, P = .002) the intervention, and epinephrine (17.54, P = .04) and norepinephrine (240.14, P = .02) levels during the intervention. After the intervention, patients visited by the volunteer-dog team showed the greatest decrease in state anxiety over patients visited by a volunteer only (6.65, P = .003) and the control group (9.13, P < .0001).
Conclusions: Animal-assisted therapy improves cardiopulmonary pressures, neurohormone levels, and anxiety in patients hospitalized with heart failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
animal-assisted therapy, dog hospital visit, heart failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Animal-assisted Therapy
Primary Outcome Measure Information:
Title
Blood pressure
Title
heart rate
Title
pulmonary artery pressure
Title
pulmonary capillary wedge pressure
Title
right atrial pressure
Title
cardiac index
Title
systemic vascular resistance
Title
plasma levels of epinephrine
Title
plasma levels of norepinephrine
Title
state anxiety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
age between 18 and 80 years
ability to read, write, and speak English
mental status: alert and oriented to person, place, and time
SVR greater than 1200 dyne · sec · cm-5 at least once within 12 hours from the start of data collection
Exclusion Criteria:
SVR less than 1200 dyne · sec · cm-5
allergies to dogs
immunosuppression, defined as a white blood cell count of less than 4500 cells/mm3
infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm3
body temperature greater than 38ºC
decreased level of consciousness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathie Cole, RN, MSN
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Gawlinski, RN, DNSc
Organizational Affiliation
UCLA Medical Center & School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
Citation
Cole K, Gawlinski A, Steers N. Animal assisted therapy decreases hemodynamics, plasma epinephrine and state anxiety in hospitalized heart failure patients. Circulation 112(17 Supplement II):527, 2005.
Results Reference
result
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Animal-Assisted Therapy for Hospitalized Heart Failure Patients
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