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OpenTrials
Completed

NCT Number: NCT06254898

Use of Incentives for 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.

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Key information

Conditions

Healthy

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado Anschutz, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Child life standard of care

Behavioral

Standard preparation and support provided to the participant by a Certified Child Life Specialist.

Child life standard of care + incentives provided with conditional agreement.

Behavioral

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.

Child life standard of care + incentive provided unconditionally.

Behavioral

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.

Primary outcomes

  1. modified Yale Preoperative Anxiety Scale (mYPAS)

    Time frame: Immediately after the intervention/procedure/surgery

    Observational measure of anxiety in pediatric patients. Scores range from 23.33 to 100, lower scores meaning less anxiety.

  2. Visual Scale Self-Report Anxiety

    Time frame: Immediately after the intervention/procedure/surgery

    Visual analog scale used for participants to report their perceived anxiety. Scores range from 0-100, lower scores meaning the participant is less anxious.

Secondary outcomes

  1. Visit Satisfaction Survey

    Time frame: Immediately after the intervention/procedure/surgery

    Visit satisfaction survey completed by the accompanying parent.

Sponsors and collaborators

Lead sponsor

Jennifer Staab, MS, CCLS

Other

Registry information

Official study title

Use of Incentives for Children Undergoing Stressful Medical Procedures

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 12, 2024
Registry last updated
Jul 13, 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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