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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 02, 2014