Elbow InjuryNCT05830201
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
A study testing No Dog Present and Dog is Present in people with Elbow Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Elbow Injury
- What is being tested?
- No Dog Present and Dog is Present
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 6 Jan 2026
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- presenting to clinic for elbow pin removal post elbow fracture surgery
Who cannot join
- dog allergy
- fear of dogs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.
Read the detailed description
This procedure is done in an outpatient clinic 3-4 weeks after the pins are placed and can be uncomfortable and cause anxiety in some patients. Therapy dogs are trained to sit calmly with a patient on or near the exam table as a distraction from procedures.
- Conditions
- Elbow Injury
- Being tested
- No Dog Present, Dog is Present
- Medical subject headings
- Elbow Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Dog PresentBehavioural
Dog is not present during pin removal
Dog is PresentBehavioural
Dog is present during pin removal
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Dog will not be in room when child has elbow pins removed Receives: Behavioral: No Dog Present |
| Therapy Dog Group | Experimental | The dog will come in a few minutes before to meet with you and your child and ensure ease. The therapy dog will be present throughout the procedure and is able to sit on the exam table if desired. Receives: Behavioral: Dog is Present |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Response
Wong-Baker FACES scale, a validated scale for assessing pain in pediatric patients, will be used to compare pain response; The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."
Measured: 1 year
Secondary outcomes (2)
Anxiety Response
anxiety response will be assessed with the Faces, Legs, Activity, Cry and Consolability (FLACC) Scale, This scale ranges from: 0 = Relaxed and comfortable ; 1-3 = Mild discomfort ; 4-6 = Moderate pain ; 7-10 = Severe discomfort/pain
Measured: 1 year
Anxiety Response
anxiety response will be assessed with heart rate in beats per minute
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 Oct 2024
- Primary completion6 Jan 2026
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elbow InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- control group or therapy group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Conklin, University of Alabama at Birmingham
- Investigators
- Michael Conklin, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830201
- Sponsor's protocol ID
- IRB-300010224
- Other IDs
- UAB
- Status last verified
- Apr 2026
- First submitted
- 3 Mar 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
- ClinicalTrials.gov ID
- NCT05830201
- Acronym / sponsor ID
- IRB-300010224
- Conditions
- Elbow Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 26 Apr 2023 (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 research study is to assess whether the presence of therapy dogs can reduce pain and anxiety in children ages 3 to 10 having pins removed from their elbow.
Detailed description
This procedure is done in an outpatient clinic 3-4 weeks after the pins are placed and can be uncomfortable and cause anxiety in some patients. Therapy dogs are trained to sit calmly with a patient on or near the exam table as a distraction from procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- control group or therapy group
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: No Dog PresentDog will not be in room when child has elbow pins removed |
| Therapy Dog Group | Experimental | Behavioral: Dog is PresentThe dog will come in a few minutes before to meet with you and your child and ensure ease. The therapy dog will be present throughout the procedure and is able to sit on the exam table if desired. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- presenting to clinic for elbow pin removal post elbow fracture surgery
Key exclusion criteria (2 listed)
- dog allergy
- 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 |
|---|---|---|
| No Dog PresentDog is not present during pin removal | Behavioural | Control Group |
| Dog is PresentDog is present during pin removal | Behavioural | Therapy Dog Group |
Primary outcome
Pain Response
Time frame: 1 year
Wong-Baker FACES scale, a validated scale for assessing pain in pediatric patients, will be used to compare pain response; The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst."
2 secondary outcomes
Anxiety Response
Time frame: 1 year
Anxiety Response
Time frame: 1 year
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 5 May 2026.
- 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.
Michael Conklin, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Dog Present and Dog is Present in people with Elbow Injury, run by University of Alabama at Birmingham 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 2 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 5 May 2026. 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?
Pain Response (time frame: 1 year). 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 5 May 2026.