Animal-Assisted Therapy for Hospitalized Heart Failure Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2006 by University of California, Los Angeles.
Recruitment status was Active, not recruiting

Sponsor:

Collaborator:

Pet Care Trust

Information provided by:

University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00391456

First received: October 23, 2006

Last updated: NA

Last verified: October 2006

History: No changes posted

Purpose

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.

Condition	Intervention
Heart Failure	Behavioral: Animal-assisted Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Use of Animal-Assisted Therapy to Decrease Cardiopulmonary Pressures, Neurohormone Levels, and State Anxiety in Patients Hospitalized With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Heart Failure

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

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

Estimated Enrollment:	76
Study Start Date:	November 2001
Estimated Study Completion Date:	July 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391456

Locations

United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Pet Care Trust

Investigators

Principal Investigator:	Kathie Cole, RN, MSN	University of California, Los Angeles
Principal Investigator:	Anna Gawlinski, RN, DNSc	UCLA Medical Center & School of Nursing

More Information

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00391456 History of Changes
Other Study ID Numbers:	#01061809, ISRCTN26749623
Study First Received:	October 23, 2006
Last Updated:	October 23, 2006
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:

animal-assisted therapy
dog hospital visit
heart failure

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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