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

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.

Study Overview

• Status: Completed
• Conditions: Elbow Injury
• Intervention / Treatment: Behavioral: No Dog Present; Behavioral: Dog is Present

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• dog allergy
• fear of dogs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Dog will not be in room when child has elbow pins removed	Behavioral: No Dog Present; Dog is not present during pin removal
Experimental: Therapy Dog Group; 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.	Behavioral: Dog is Present; Dog is present during pin removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Anxiety Response	anxiety response will be assessed with heart rate in beats per minute	1 year

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Michael Conklin, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): January 6, 2026
• Study Completion (Actual): January 6, 2026

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Elbow Injuries
• Other Study ID Numbers: IRB-300010224; UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No