AnxietyNCT04942678
The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
An observational study of Anxiety and Emotional Regulation, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Emotional Regulation
- What is being tested?
- 10-minute visit with therapy dog and child life specialist handler
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2021to 26 Jul 2021
- Phase
- Observational
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients will be recruited at both Norton Children's Hospital Emergency Department and Norton Children's Medical Center Emergency department.
Who may be able to join
- Children with a SUD score of 30 or higher indicated by the caregiver
Who cannot join
- Active infection: abscesses, fever, respiratory issues, vomiting
- Patients presenting for burn care, dog bite, ESI triage category 1 or 2, or transferred from outside facilities
- Sterile procedures
- Oncology patients / patients with known neutropenia in past medical history
- Parent/caregiver or patient fear of dogs
- Parent/caregiver or patient allergy to dogs
- Dog bite injury
- Already underwent procedure during their visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Norton Children's Hospital
Louisville, Kentucky, 40202
About this study
The purpose of this study is to assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.
- Conditions
- Anxiety, Emotional Regulation
- Being tested
- 10-minute visit with therapy dog and child life specialist handler
- Keywords
- Pediatric Emergency Medicine, Therapy Animals, Animal Assisted Therapy, Anxiety, Emotional Regulation
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-minute visit with therapy dog and child life specialist handlerBehavioural
A visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes. Parents and patients will be asked to sanitize their hand prior to the visit. The child life specialist will be instructed to have ad lib conversation with the family. The dog will remain on a leash during the visit. The patient will be free to pet the therapy dog if they wish.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients ages 4-7 years old in the Pediatric Emergency Department | Patients will receive a 10-minute visit with therapy dog and child life handler Receives: Behavioral: 10-minute visit with therapy dog and child life specialist handler | |
| Pediatric patients ages 8-12 years old in the Pediatric Emergency Department | Patients will receive a 10-minute visit with therapy dog and child life handler Receives: Behavioral: 10-minute visit with therapy dog and child life specialist handler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit
To determine the change in emotional management in children aged 4-12 years after a visit from a therapy dog and child life specialist handler, as measured by an observed CEMS score (Children's Emotional Management Scale) before and after the visit. This will be completed by an investigator. Scores range from 5-25, with higher scores indicating higher levels of observed anxiety.
Measured: change from baseline at 20 minutes after intervention
Secondary outcomes (2)
Change in perceived anxiety level of patient by parent as measured by Subjective Units of Distress Scale (SUDs) before and after therapy Dog Visit
To determine the change in perceived level of child anxiety as reported by parents after a visit with a therapy dog and child life specialist handler. This will be measured using the Subjective Unit of Distress (SUD) score. Scores range from 0-100 with higher scores indicating higher levels of perceived anxiety by the parent.
Measured: change from baseline at 20 minutes after intervention
Overall Parent Satisfaction
Parents will complete a survey describing their satisfaction with their visit
Measured: Immediately after completion of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 May 2021
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle D. Stevenson, University of Louisville
- Investigators
- Michelle D Stevenson, MD, MS, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942678
- Sponsor's protocol ID
- 21.0190
- Status last verified
- Mar 2022
- First submitted
- 25 Mar 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Therapy Dogs on Anxiety and Emotional Management in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT04942678
- Acronym / sponsor ID
- 21.0190
- Conditions
- Anxiety, Emotional Regulation
- Keywords
- Pediatric Emergency Medicine, Therapy Animals, Animal Assisted Therapy, Anxiety, Emotional Regulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 25 May 2021 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 28 Jun 2021 (actual)
- 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 assess the impact of therapy dogs on children's anxiety and emotional management during a visit to the pediatric emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients ages 4-7 years old in the Pediatric Emergency Department | – | Behavioral: 10-minute visit with therapy dog and child life specialist handlerPatients will receive a 10-minute visit with therapy dog and child life handler |
| Pediatric patients ages 8-12 years old in the Pediatric Emergency Department | – | Behavioral: 10-minute visit with therapy dog and child life specialist handlerPatients will receive a 10-minute visit with therapy dog and child life handler |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients will be recruited at both Norton Children's Hospital Emergency Department and Norton Children's Medical Center Emergency department.
Key inclusion criteria (1 listed)
- Children with a SUD score of 30 or higher indicated by the caregiver
Key exclusion criteria (8 listed)
- Active infection: abscesses, fever, respiratory issues, vomiting
- Patients presenting for burn care, dog bite, ESI triage category 1 or 2, or transferred from outside facilities
- Sterile procedures
- Oncology patients / patients with known neutropenia in past medical history
- Parent/caregiver or patient fear of dogs
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 |
|---|---|---|
| 10-minute visit with therapy dog and child life specialist handlerA visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes. Parents and patients will be asked to sanitize their hand prior to the visit. The child life specialist will be instructed to have ad lib conversation with the family. The dog will remain on a leash during the visit. The patient will be free to pet the therapy dog if they wish. | Behavioural | Pediatric patients ages 4-7 years old in the Pediatric Emergency Department, Pediatric patients ages 8-12 years old in the Pediatric Emergency Department |
Primary outcome
Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit
Time frame: change from baseline at 20 minutes after intervention
To determine the change in emotional management in children aged 4-12 years after a visit from a therapy dog and child life specialist handler, as measured by an observed CEMS score (Children's Emotional Management Scale) before and after the visit. This will be completed by an investigator. Scores range from 5-25, with higher scores indicating higher levels of observed anxiety.
2 secondary outcomes
Change in perceived anxiety level of patient by parent as measured by Subjective Units of Distress Scale (SUDs) before and after therapy Dog Visit
Time frame: change from baseline at 20 minutes after intervention
Overall Parent Satisfaction
Time frame: Immediately after completion of intervention
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 17 Mar 2022.
- 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.
Michelle D Stevenson, MD, MS principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Emotional Regulation, run by University of Louisville 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 1 inclusion and 8 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 17 Mar 2022. 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?
Change in observed anxiety score as measured by Child Emotional Manifestation Scale (CEMS) before and after therapy dog visit (time frame: change from baseline at 20 minutes after intervention). 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 17 Mar 2022.