Use of Incentives for Stressful Medical Procedures

Healthy Clinical Trial

Official title:

Use of Incentives for Children Undergoing Stressful Medical Procedures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254898
• Other study ID #: 23-0337
• Status: Recruiting
• Phase: N/A
• Start date: June 2, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital Colorado
• Contact: Jennifer Staab, MS
• Phone: 720-777-3264
• Email: jennifer.staab[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 187
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Child life standard of care
Standard preparation and support provided to the participant by a Certified Child Life Specialist.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado Anschutz	Aurora	Colorado
United States	Children's Hospital Colorado North Campus	Broomfield	Colorado
United States	Children's Hospital Colorado South Campus	Highlands Ranch	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Jennifer Staab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Visit Satisfaction Survey	Visit satisfaction survey completed by the accompanying parent.	Immediately after the intervention/procedure/surgery