Condition category
Circulatory System
Date applied
11/10/2006
Date assigned
13/10/2006
Last edited
30/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anna Gawlinski

ORCID ID

Contact details

UCLA School of Nursing
10833 Le Conte Ave.
Los Angeles
90095
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00391456

Protocol/serial number

Grant number: 01061809

Study information

Scientific title

Acronym

AAT

Study hypothesis

To determine whether a 12-minute hospital visit with a therapy dog improves haemodynamics, lowers neurohormone levels, and decreases state anxiety in patients hospitalised with heart failure.

Ethics approval

University of California and Los Angeles Institutional Review Board (UCLA IRB) approved November 2001.

Study design

A three group, randomised, repeated-measures experimental design.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

Group one: 12-minute visit from a volunteer with a therapy dog
Group two: 12-minute visit from a volunteer
Group three: control group, received usual care

Data were collected at baseline, eight minutes after the intervention started, and 16 minutes (four minutes after intervention ended).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Haemodynamics
2. Neurohormonal levels
3. State anxiety

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/11/2001

Overall trial end date

31/07/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of heart failure requiring medical management with an indwelling pulmonary artery catheter
2. Age between 18 and 80 years
3. Ability to read, write, and speak English
4. Orientation status of alert and oriented to person, place, and time
5. Systemic Vascular Resistance (SVR) greater than 1200 dyne/sec/cm^-5 at least once within 12 hours from the start of data collection

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

76

Participant exclusion criteria

1. SVR less than 1200 dyne/sec/cm^-5
2. Allergies to dogs
3. Immunosuppression, defined as a white blood cell count of less than 4500 cells/mm^3
4. Infection as determined by an elevated white blood cell count exceeding 11,000 cells/mm^3
5. Body temperature greater than 38 degrees Celsius
6. Decreased level of consciousness

Recruitment start date

01/11/2001

Recruitment end date

31/07/2004

Locations

Countries of recruitment

United States of America

Trial participating centre

UCLA School of Nursing
Los Angeles
90095
United States of America

Sponsor information

Organisation

Pet Care Trust Foundation (USA)

Sponsor details

The Southern Building
805 15th Street
9th Floor
Washington
DC
20005
United States of America

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Pet Care Trust Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17962502

Publication citations

  1. Results

    Cole KM, Gawlinski A, Steers N, Kotlerman J, Animal-assisted therapy in patients hospitalized with heart failure., Am. J. Crit. Care, 2007, 16, 6, 575-85; quiz 586; discussion 587-8.

Additional files

Editorial Notes