NCT00391456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2001

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

First QC Date

October 23, 2006

Last Update Submit

June 1, 2016

Conditions

Keywords

animal-assisted therapydog hospital visitheart failure

Outcome Measures

Primary Outcomes (10)

  • 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

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Heart Failure

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kathie Cole, RN, MSN

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
  • Anna Gawlinski, RN, DNSc

    UCLA Medical Center & School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 24, 2006

Study Start

November 1, 2001

Study Completion

July 1, 2004

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations