Use of Incentives for Stressful Medical Procedures

NCT ID: NCT06254898

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Child life standard of care

Child life standard of care

Group Type ACTIVE_COMPARATOR

Child life standard of care

Intervention Type 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.

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Child life standard of care + incentive provided unconditionally.

Group Type EXPERIMENTAL

Child life standard of care + incentive provided unconditionally.

Intervention Type 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.

Interventions

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Child life standard of care

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

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jennifer Staab, MS, CCLS

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Staab, MS, CCLS

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Children's Hospital Colorado Anschutz

Aurora, Colorado, United States

Site Status RECRUITING

Children's Hospital Colorado North Campus

Broomfield, Colorado, United States

Site Status RECRUITING

Children's Hospital Colorado South Campus

Highlands Ranch, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Staab, MS

Role: CONTACT

720-777-3264

Facility Contacts

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Claire Simonsen, BA

Role: primary

720-777-5313

Claire Simonsen, BA

Role: primary

720-777-5313

Claire Simonsen, BA

Role: primary

720-777-5313

Other Identifiers

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23-0337

Identifier Type: -

Identifier Source: org_study_id

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