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Completed

NCT Number: NCT05830201

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.

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Key information

Conditions

Elbow Injury Arm Injuries Elbow Injuries Wounds and Injuries

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • dog allergy
  • fear of dogs

Treatment and study plan

No Dog Present

Behavioral

Dog is not present during pin removal

Dog is Present

Behavioral

Dog is present during pin removal

Primary outcomes

  1. 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."

Secondary outcomes

  1. Anxiety Response

    Time frame: 1 year

    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

  2. Anxiety Response

    Time frame: 1 year

    anxiety response will be assessed with heart rate in beats per minute

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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