NCT05830201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

March 3, 2023

Last Update Submit

April 29, 2026

Conditions

Elbow Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Anxiety Response

    1 year

  • Anxiety Response

    1 year

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Behavioral: No Dog Present

Therapy Dog Group

EXPERIMENTAL

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

Interventions

No Dog PresentBEHAVIORAL

Dog is not present during pin removal

Control Group
Dog is PresentBEHAVIORAL

Dog is present during pin removal

Therapy Dog Group

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • dog allergy
  • fear of dogs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Elbow Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Study Officials

  • Michael Conklin, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: control group or therapy group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2023

First Posted

April 26, 2023

Study Start

October 1, 2024

Primary Completion

January 6, 2026

Study Completion

January 6, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)