Use of Incentives for Stressful Medical Procedures

NCT06254898 | Completed

• 1 other identifier: 23-0337
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 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.

Conditions

Healthy

Keywords

pediatrics; child life; medical procedures

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 COMPARATOR

Child life standard of care

Behavioral: Child life standard of care

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

EXPERIMENTAL

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

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

Child life standard of care + incentive provided unconditionally.

EXPERIMENTAL

Child life standard of care + incentive provided unconditionally.

Behavioral: Child life standard of care + incentive provided unconditionally.

Interventions

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

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.

Child life standard of care + incentive provided unconditionally.

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 + incentives provided with conditional agreement.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Jennifer Staab, MS, CCLS: lead

Study Sites (3)

Children's Hospital Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Children's Hospital Colorado North Campus

Broomfield, Colorado, 80023, United States

Location

Children's Hospital Colorado South Campus

Highlands Ranch, Colorado, 80129, United States

Location

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: June 8, 2026
• Study Completion: June 8, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (3)