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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05830201
Collaborator
(none)
50
Enrollment
2
Arms
17.1
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: No Dog Present
  • Behavioral: Dog is Present
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
control group or therapy groupcontrol group or therapy group
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Presence of a Therapy Dog Reduces Pain and Anxiety During Pediatric Elbow Pin Removal
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Pain Response [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 Outcome Measures

  1. Anxiety Response [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 [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • presenting to clinic for elbow pin removal post elbow fracture surgery
Exclusion Criteria:

  • dog allergy

  • fear of dogs

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael J. Conklin, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05830201
Other Study ID Numbers:
  • IRB-300010224
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 26, 2023