Therapy Dogs for Pediatric Elbow Injuries

Overseen By Patrick Frazier

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Dog allergy, fear of dogs

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether therapy dogs can help reduce pain and anxiety in children during elbow pin removal after surgery. Participants are divided into two groups: one with a therapy dog present during the procedure and one without. Children visiting the clinic for elbow pin removal after fracture surgery, who do not have a dog allergy or fear of dogs, might be suitable candidates. As an unphased trial, this study offers children a unique opportunity to potentially experience comfort and reduced anxiety during their procedure.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that therapy dogs are safe for children during medical procedures?

Research shows that therapy dogs, also known as animal-assisted therapy, are generally safe for children. Studies have found that therapy dogs can help reduce stress and anxiety. They can also lower blood pressure and provide a distraction during stressful times, making them helpful for children during medical procedures.

Importantly, positive experiences with therapy dogs have been reported, and no major safety concerns have emerged. Children and parents often find comfort in having a therapy dog present. The dog's role is to make the situation feel less scary and more manageable. Those considering joining a trial with therapy dogs can feel confident that they are well-tolerated and help create a calming environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatment options for pediatric elbow injuries, which typically involve pain management through medications such as acetaminophen or ibuprofen, therapy dogs offer a completely different approach by providing emotional comfort and reducing anxiety. Researchers are excited about therapy dogs because they have the potential to make the experience of medical procedures less stressful for children. This method is unique because it leverages the calming presence of a trained dog, which can help distract from pain and fear without any pharmacological intervention.

What evidence suggests that therapy dogs might be an effective treatment for reducing pain and anxiety in children with elbow injuries?

Studies have shown that therapy dogs can reduce pain and anxiety in children during medical procedures. Research indicates that having a therapy dog nearby helps kids feel more relaxed and less scared. Spending time with animals often releases calming hormones in the body, such as oxytocin. Previous patients felt happier and less stressed with therapy dogs present. In this trial, some participants will have a therapy dog present during elbow pin removal, potentially making the experience less painful and frightening for children. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Conklin, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 10 who are scheduled to have pins removed from their elbow after a fracture surgery. It's not suitable for kids outside this age range or those having different medical procedures.

Inclusion Criteria

I am going to the clinic to have pins removed from my elbow after a fracture surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo elbow pin removal with or without the presence of a therapy dog

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety response after the procedure

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Therapy Dog

Trial Overview The study is testing if having a therapy dog in the room can help reduce pain and anxiety during the process of removing pins from a child's elbow compared to not having a dog present.

How Is the Trial Designed?

Group I: Therapy Dog Group Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

Dog will not be in room when child has elbow pins removed

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A study involving 50 children in a Swedish paediatric surgery ward found that their well-being significantly improved after interacting with a therapy dog, with feelings shifting from mixed to predominantly positive.

93% of the children rated their experience with the therapy dog as very good, indicating that animal-assisted therapy can be an effective complementary treatment in enhancing children's hospital experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Children report positive experiences of animal-assisted therapy in paediatric hospital care. Lindström Nilsson, M., Funkquist, EL., Edner, A., et al.[2021]

A novel technique was developed to load the canine elbow joint and assess changes in joint congruency using computed tomography, revealing significant alterations in joint space with increasing load from 0% to 100% of body weight across five pairs of limbs.

The study found that increased loading led to significant changes in humero-radio-ulnar congruency, particularly in the lateral compartment, suggesting that this loading may contribute to the development of medial coronoid process disease in dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CT assessment of the influence of dynamic loading on physiological incongruency of the canine elbow. Burton, NJ., Warren-Smith, CM., Roper, DP., et al.[2013]

In a study of eight dogs with elbow pain due to incomplete fractures of the humeral condyle, radiographic examination was crucial for diagnosis, identifying a specific radiolucent line as a key indicator.

Treatment using a transcondylar bone screw resulted in complete recovery for six dogs (nine elbows), demonstrating the efficacy of this surgical intervention with no reported complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incomplete humeral condylar fractures in the dog. Butterworth, SJ., Innes, JF.[2019]

In a clinical trial with 80 emergency department patients, exposure to therapy dogs significantly reduced anxiety levels compared to usual care, with anxiety scores dropping from a median of 6 to 2 after 15 minutes with the dog.

Patients who interacted with therapy dogs also showed a trend towards lower pain medication use, with only 1 out of 40 needing pain relief compared to 7 out of 40 in the control group, suggesting potential benefits for pain management as well.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled clinical trial of canine therapy versus usual care to reduce patient anxiety in the emergency department. Kline, JA., Fisher, MA., Pettit, KL., et al.[2020]

The presence of a therapy dog in a student-led occupational therapy clinic significantly enhanced children's engagement during therapy sessions, as reported by both students and parents.

Participants identified that the relationship between the children and the therapy dog fostered a sense of safety, which in turn encouraged the children to participate more actively in their therapy activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canine-Assisted Occupational Therapy for Children within a Student-Led University Clinic: The Influence on Child Engagement from the Perspectives of Student and Parent Participants. Hill, J., Mensforth, S., Waldby, L., et al.[2023]

A study using CT scans on 7 clinically normal dogs provided detailed images of the elbow joint structures, allowing for comprehensive evaluation of both bony and soft tissue components.

The findings suggest that CT imaging can serve as a valuable tool for assessing elbow joint injuries in dogs, offering clear anatomical details that can aid in diagnosis and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed tomography of the elbow joint in clinically normal dogs. De Rycke, LM., Gielen, IM., van Bree, H., et al.[2019]

A 2.5-year-old crossbreed dog was successfully treated for a rare case of traumatic partial elbow luxation (medial humeroulnar) using closed reduction under general anesthesia.

The treatment resulted in an excellent functional outcome, indicating that closed reduction can be an effective intervention for this type of elbow injury in dogs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic partial elbow luxation in a dog. Bongartz, A., Carofiglio, F., Piaia, T., et al.[2016]

Canine-assisted occupational therapy can enhance emotional safety and rapport between children on the autism spectrum and their therapists, as reported by parents in a study involving 10 participants.

However, the presence of a therapy dog alone is not enough to ensure engagement; the therapist's skills and the structure of goal-directed therapy are crucial for effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canine-assisted occupational therapy for children on the autism spectrum: Parents' perspectives. Hill, JR., Ziviani, J., Driscoll, C.[2021]

Most injuries in small mammals happen at home, and their diagnosis and treatment can be similar to that of dogs and cats, but must account for species-specific differences.

For treating fractures in small mammals, a butterfly-cast may be effective in certain cases, while a 'tie-in-fixator' generally provides satisfactory stabilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fractures and luxations in small mammals]. Fehr, M., Thomas, M., Baur, S., et al.[2016]

In a randomized controlled trial with 26 pediatric oncology inpatients, dog visits did not significantly improve psychological functioning compared to usual care, indicating limited efficacy in this area.

However, dog visits were associated with reduced anxiety levels in parents of the patients, suggesting a potential benefit for family members during treatment, while also not increasing microbial load on hands after sanitization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Animal-assisted Activities for Pediatric Oncology Patients: Psychosocial and Microbial Outcomes. Chubak, J., Adler, A., Bobb, JF., et al.[2023]

Animal-assisted therapy, particularly with trained therapy dogs, has been shown to provide significant pain relief, supported by both subjective reports and objective measures such as decreased catecholamines and increased endorphins in humans.

The therapeutic benefits of therapy dog visits may be explained by various mechanisms, including mirror neuron activity and the dogs' olfactory abilities, which help them connect with humans during these interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The science behind animal-assisted therapy. Marcus, DA.[2021]

Animal-assisted therapy (AAT) is a collaborative approach that integrates various health disciplines to enhance human health through interactions with qualified therapy animals, particularly dogs.

In Taiwan, the development of canine AAT has been documented, highlighting its benefits and outcomes, while also addressing practical challenges and suggesting improvements for future services and research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lassie's magic: animal-assisted therapy in Taiwan]. Yeh, ML.[2009]

Animal assisted therapy can significantly improve communication, psychosocial skills, and academic or pre-vocational functioning in children and adolescents with disabilities.

The article provides resources for implementing animal assisted therapy programs within occupational therapy practices, highlighting its potential as a beneficial treatment modality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Animal assisted therapy for children and adolescents with disabilities. Poleshuck, LR.[2014]

Citations

1. withpower.com withpower.com/trial/phase-elbow-injury-6-2023-67ea3

Therapy Dogs for Pediatric Elbow Injuries 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 ...

2. go.drugbank.com go.drugbank.com/conditions/DBCOND0054312

Elbow Injury (DBCOND0054312) NCT05830201. The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal, No drug interventions ; NCT03756155. Isometric ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11167866/

The role of dog therapy in clinical recovery and improving ... Animal assisted therapy may be helpful in the rehabilitation process and in the treatment of patients to alleviate this phenomenon.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05551156

The Role of Therapy Dogs in Reducing Depression ... The purpose of this research study is to test whether an animal-assisted intervention (AAI) is better than conversation with another person or treatment as ...

5. mdpi.com mdpi.com/2227-9067/11/8/1017

Exploring the Benefits of Dog-Assisted Therapy for ... This systematic review examines whether dog-assisted therapy has beneficial impacts on the treatment of complex trauma and whether it can decrease treatment ...

6. insidepeds.org insidepeds.org/category/inside-pediatrics/orthopedics-inside-pediatrics/

Orthopedics - Inside Pediatrics Conklin and his team are conducting a randomized trial to evaluate the dogs' effectiveness, comparing outcomes between patients who receive the therapy dog ...

7. uofmhealth.org uofmhealth.org/patients-visitors/support-services/animal-therapy

Animal Therapy | University of Michigan ... Research shows that animal therapy can lower stress and anxiety levels, improve blood pressure, increase patient mobility, and provide an alternative focus from ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7601402/

Assessing the Outcomes of an Animal-Assisted ... The study showed that implementation of an animal-assisted programme at a paediatric day hospital is feasible. Children and parents both gave ...

9. shrinerschildrens.org shrinerschildrens.org/en/news-and-media/news/2024/02/healing-through-pet-therapy

Shriners Children's Heals Through Pet Therapy Animal-assisted therapy is shown to help reduce stress for children, making their hospital stay a little less scary.