Use of Incentives for Stressful Medical Procedures
Use of Incentives for Children Undergoing Stressful Medical Procedures
1 other identifier
interventional
187
1 country
3
Brief Summary
The goal of this clinical trial is to learn about the use of incentives in pediatric patients requiring medical procedures. The main questions it aims to answer are: Are incentives effective at reducing pediatric anxiety for medical procedures? What is the best way to use incentives with pediatric populations requiring medical procedures? Participants will be provided support in preparation for their procedure and during the procedure by a child life specialist and might receive an incentive prize after their procedure. Participants distress levels during the procedure will be observed and they will be asked to rate their anxiety on a visual analog scale. Researchers will compare the anxiety of those who did or did not receive an incentive after their procedure to see if incentives reduced procedural anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jun 2023
Longer than P75 for not_applicable healthy
3 active sites
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
Study Start
First participant enrolled
June 2, 2023
CompletedFirst Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedSeptember 16, 2025
September 1, 2025
2.5 years
December 7, 2023
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
modified Yale Preoperative Anxiety Scale (mYPAS)
Observational measure of anxiety in pediatric patients. Scores range from 23.33 to 100, lower scores meaning less anxiety.
Immediately after the intervention/procedure/surgery
Visual Scale Self-Report Anxiety
Visual analog scale used for participants to report their perceived anxiety. Scores range from 0-100, lower scores meaning the participant is less anxious.
Immediately after the intervention/procedure/surgery
Secondary Outcomes (1)
Visit Satisfaction Survey
Immediately after the intervention/procedure/surgery
Study Arms (3)
Child life standard of care
ACTIVE COMPARATORChild life standard of care
Child life standard of care + incentives provided with conditional agreement.
EXPERIMENTALChild life standard of care + incentives provided with conditional agreement.
Child life standard of care + incentive provided unconditionally.
EXPERIMENTALChild life standard of care + incentive provided unconditionally.
Interventions
Standard preparation and support provided to the participant by a Certified Child Life Specialist.
Patient is provided standard preparation and support provided to the participant by a Certified Child Life Specialist. Before the procedure the child life specialist discusses earning a prize with the patient if they demonstrate the agreed upon coping goal (i.e. holding arm still, taking deep breaths, engaging in distraction.) At the end of the procedure the patient is provided with the prize if they earn the prize based on the agreed upon coping plan.
Patient is provided standard preparation and support provided to the participant by a Certified Child Life Specialist. After the procedure is complete the patient is provided with a prize. The patient does not need to do anything to earn the prize.
Eligibility Criteria
You may qualify if:
- Patients and parent of patients aged 6-100 years who are undergoing a medical procedure
- Patients and parent of patients who are prepared and supported by a certified child life specialist.
You may not qualify if:
- Cognitive impairment that negates the use of the outcome tools
- Children younger than 6 years old, or older than 17 years old.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Children's Hospital Colorado Anschutz
Aurora, Colorado, 80045, United States
Children's Hospital Colorado North Campus
Broomfield, Colorado, 80023, United States
Children's Hospital Colorado South Campus
Highlands Ranch, Colorado, 80129, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 7, 2023
First Posted
February 12, 2024
Study Start
June 2, 2023
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
September 16, 2025
Record last verified: 2025-09