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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02363608
Other study ID # 15-010
Secondary ID
Status Completed
Phase N/A
First received February 5, 2015
Last updated January 12, 2017
Start date January 2015

Study information

Verified date January 2017
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to describe the effects of canine-assisted activity visits on patients and staff in a hospital setting. The Caring Canines program uses dogs who have been trained to be obedient, calm and comforting. It involves a visit by a volunteer (called the dog's handler) and the volunteer's dog that has been trained and tested to have a good personality and to follow commands. A visit typically lasts about 10-15 minutes with the patient interacting with the dog while the dog is supervised by the handler. Memorial Sloan Kettering currently has Caring Canine dogs visit patients but the investigators don't yet know the impact of these visits on patients and staff. The investigators would like to see how the Caring Canine visits impact a patients' mood, including anxiety, stress, and sense of well-being. Two groups of patients will take part in this study - the first group will receive standard post surgery care and will not receive a visit from the Caring Canines program and the second group will receive daily visits (Tuesday -Friday) from the Caring Canines program while they are on M15. The purpose of this study is to look at differences in well-being between patients who have the visits with the dogs and patients who do not.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

Patients

- Age greater than 21

- Admitted to M15 following a Monday or Tuesday surgery

- Ability to speak and read English.

Staff

- Age greater than 21

- Works at least one day shift a week on M15

- Ability to speak and read English

Exclusion Criteria:

Patients

- Self reported allergy to dogs

- Medical need to be in an isolation room

- Medical need to be in a Protective Environment room .

Staff

- Self reported allergy to dogs

Study Design


Related Conditions & MeSH terms


Intervention

Other:
standard post surgery care

Behavioral:
Caring Canine program
The therapy dogs who visit at MSKCC. A visit by a therapy dog typically lasts about 10-15 minutes with the patient interacting with the therapy dog while the dog is supervised by the handler.
baseline and post assessment
The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary change from baseline in the follow-up PHQ-4 scores The PHQ-4 is an ultra-brief self-report questionnaire that consists of a 2-item depression scale and a 2 item anxiety scale. Among the control and intervention groups to assess psychological effects of the program. Responses on the pain scale will assess physiological effects, and responses on the open-ended questions will identify patient-perceived benefits of the program 1 year
Primary difference in baseline and follow-up ProQOL scores (For Staff) (Compassion Satisfaction score and Burnout score) to assess change in work satisfaction due to the program, and responses on the qualitative questions will address staff-perceived benefits of the program. 1 year
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