Use of Animal-Assisted Therapy to decrease cardiopulmonary pressures, neurohormone levels, and state anxiety in patients hospitalised with heart failure
| ISRCTN | ISRCTN26749623 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26749623 |
| ClinicalTrials.gov (NCT) | NCT00391456 |
| Protocol serial number | Grant number: 01061809 |
| Sponsor | Pet Care Trust Foundation (USA) |
| Funder | Pet Care Trust Foundation (USA) |
- Submission date
- 11/10/2006
- Registration date
- 13/10/2006
- Last edited
- 30/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Anna Gawlinski
Scientific
Scientific
UCLA School of Nursing
10833 Le Conte Ave.
Los Angeles
90095
United States of America
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A three group, randomised, repeated-measures experimental design. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | AAT |
| Study objectives | 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(s) | University of California and Los Angeles Institutional Review Board (UCLA IRB) approved November 2001. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Haemodynamics |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Not Specified |
| Target sample size at registration | 76 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2001 |
| Date of final enrolment | 31/07/2004 |
Locations
Countries of recruitment
- United States of America
Study participating centre
UCLA School of Nursing
Los Angeles
90095
United States of America
90095
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2007 | Yes | No |
