The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal

Elbow Injury Clinical Trial

Official title:

The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830201
• Other study ID #: IRB-300010224
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2025
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Patrick Frazier
• Phone: 205-641-0824
• Email: thomasfrazier[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

Inclusion Criteria:

• presenting to clinic for elbow pin removal post elbow fracture surgery

Exclusion Criteria:

• dog allergy

• fear of dogs

Related Conditions & MeSH terms

• Elbow Injuries
• Elbow Injury

Intervention

Behavioral:
• No Dog Present
Dog is not present during pin removal
• Dog is Present
Dog is present during pin removal

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	1 year
Secondary	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	1 year
Secondary	Anxiety Response	anxiety response will be assessed with heart rate in beats per minute	1 year