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CompletedNCT00391456Updated Jun 3, 2016

Animal-Assisted Therapy for Hospitalized Heart Failure Patients

An interventional study of Animal-assisted Therapy in Heart Failure, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-03.

Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • animal-assisted therapy
  • dog hospital visit
  • heart failure
03

In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's enrollment of 76 is close to the median of 72 across 3,790 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 69 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
76 participants

Interventions

  • BehavioralAnimal-assisted Therapy
06

What researchers measure

Primary outcomes

  1. Blood pressure

  2. heart rate

  3. pulmonary artery pressure

  4. pulmonary capillary wedge pressure

  5. right atrial pressure

  6. cardiac index

  7. systemic vascular resistance

  8. plasma levels of epinephrine

  9. plasma levels of norepinephrine

  10. state anxiety

07

Study locations

1 site
  • UCLA Medical Center
    Los Angeles, California 90095, United States
08

References and documents

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.
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2001 and a completion of Jul 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2006
First posted
Oct 24, 2006
Start
Nov 2001
Completion
Jul 2004
Last update
Jun 3, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Jun 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00391456
Collaborators
Pet Care Trust
First posted
Oct 24, 2006
Start date
Nov 2001
Completion
Jul 2004
Last update
Jun 3, 2016

Study contacts

Kathie Cole, RN, MSN
principal investigator · University of California, Los Angeles
Anna Gawlinski, RN, DNSc
principal investigator · UCLA Medical Center & School of Nursing
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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