Use of Incentives for Stressful Medical Procedures

Use of Incentives for Children Undergoing Stressful Medical Procedures

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Child life standard of care; Behavioral: Child life standard of care + incentives provided with conditional agreement.; Behavioral: Child life standard of care + incentive provided unconditionally.

Detailed Description

The purpose of this study is to evaluate the impact incentives have on the distress and cooperation of children undergoing stressful medical procedures. The primary aim is to determine if offering an incentive reduces procedural distress for children undergoing stressful medical procedures. Secondly, if an incentive is offered does the process for offering the incentive (conditional or unconditional) to the patient impact the procedural distress of the patient. Patient anxiety and visit satisfaction will be looked at as secondary measures.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado Anschutz
    • Broomfield, Colorado, United States, 80023
      • Children's Hospital Colorado North Campus
    • Highlands Ranch, Colorado, United States, 80129
      • Children's Hospital Colorado South Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Cognitive impairment that negates the use of the outcome tools
• Children younger than 6 years old, or older than 17 years old.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Child life standard of care	Behavioral: Child life standard of care; Standard preparation and support provided to the participant by a Certified Child Life Specialist.
Experimental: Child life standard of care + incentives provided with conditional agreement.	Behavioral: Child life standard of care + incentives provided with conditional agreement.; 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.
Experimental: Child life standard of care + incentive provided unconditionally.	Behavioral: Child life standard of care + incentive provided unconditionally.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visit Satisfaction Survey	Visit satisfaction survey completed by the accompanying parent.	Immediately after the intervention/procedure/surgery

Collaborators and Investigators

• Sponsor: Jennifer Staab, MS, CCLS

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2023
• Primary Completion (Actual): June 8, 2026
• Study Completion (Actual): June 8, 2026

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pediatrics; child life; medical procedures
• Other Study ID Numbers: 23-0337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No