Hospitalized PatientsNCT02959632
Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center
A study testing Animal Assisted Therapy in people with Hospitalized Patients, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of hospitalized patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hospitalized Patients
- What is being tested?
- Animal Assisted Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to St Mary's or Methodist Hospital and subsequently referred for AAT.
- Subjects undergoing Animal Assisted Therapy as part of their standard care.
- Patients 18-80 years of age.
- Patients who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.
- Care team members of the study participants.
- 18-80 years of age.
- Who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.
Who cannot join
- Patients with diagnoses of bipolar disorder, schizophrenia or dementia.
- Unable to give consent.
- Pregnant women (as verbalized by participant).
- Care team members of the study participants who do not want to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center: A Pilot Study
The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of hospitalized patients.
Read the detailed description
Animal Assisted Therapy is being provided by the Caring Canines program and is formally available to patients by referrals. In this study, we would like to capture why patients are being referred and to measure the influence of AAT on the symptoms and feelings of patients.
- Conditions
- Hospitalized Patients
- Being tested
- Animal Assisted Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal Assisted TherapyBehavioural
Animal Assisted Therapy is the program where a pet, usually dog will visit and interact with the patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving AAT | Experimental | Hospitalized patients receiving Animal Assisted Therapy (AAT).
Animal Assisted Therapy (Pet Visit) will be provided to the hospitalized patients. Receives: Behavioral: Animal Assisted Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients scoring improvement of symptoms using the VAS (visual analogue scale)
We will record the number of patients scoring improvement of symptoms using the VAS (visual analogue scale).
Measured: Baseline to 45 minutes
Secondary outcomes (1)
Number of patients scoring improvement of feelings using the VAS (visual analogue scale)
We will record the number of patients scoring improvement of feelings using the VAS (visual analogue scale).
Measured: Baseline to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jul 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Ying (Christina) Chen, Mayo Clinic
- Investigators
- Brent A Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959632
- Sponsor's protocol ID
- 16-007730
- Status last verified
- Jan 2021
- First submitted
- 4 Nov 2016
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Animal Assisted Therapy Intervention for Hospitalized Patients in a Tertiary Care Center: A Pilot Study
- ClinicalTrials.gov ID
- NCT02959632
- Acronym / sponsor ID
- 16-007730
- Conditions
- Hospitalized Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the common symptoms leading to an Animal Assisted Therapy consult, and to measure its (AAT) influence on the symptoms and feelings of hospitalized patients.
Detailed description
Animal Assisted Therapy is being provided by the Caring Canines program and is formally available to patients by referrals. In this study, we would like to capture why patients are being referred and to measure the influence of AAT on the symptoms and feelings of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving AAT | Experimental | Behavioral: Animal Assisted TherapyHospitalized patients receiving Animal Assisted Therapy (AAT). Animal Assisted Therapy (Pet Visit) will be provided to the hospitalized patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients admitted to St Mary's or Methodist Hospital and subsequently referred for AAT.
- Subjects undergoing Animal Assisted Therapy as part of their standard care.
- Patients 18-80 years of age.
- Patients who are able to read and answer pre and post intervention survey questionnaire and satisfaction survey.
- Care team members of the study participants.
Key exclusion criteria (4 listed)
- Patients with diagnoses of bipolar disorder, schizophrenia or dementia.
- Unable to give consent.
- Pregnant women (as verbalized by participant).
- Care team members of the study participants who do not want to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal Assisted TherapyAnimal Assisted Therapy is the program where a pet, usually dog will visit and interact with the patients. | Behavioural | Patients receiving AAT |
Primary outcome
Number of patients scoring improvement of symptoms using the VAS (visual analogue scale)
Time frame: Baseline to 45 minutes
We will record the number of patients scoring improvement of symptoms using the VAS (visual analogue scale).
1 secondary outcome
Number of patients scoring improvement of feelings using the VAS (visual analogue scale)
Time frame: Baseline to 45 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brent A Bauer, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal Assisted Therapy in people with Hospitalized Patients, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients scoring improvement of symptoms using the VAS (visual analogue scale) (time frame: Baseline to 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.