Use of Incentives for Stressful Medical Procedures

February 20, 2024 updated by: Jennifer Staab

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
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.
Immediately after the intervention/procedure/surgery
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.
Immediately after the intervention/procedure/surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jennifer Staab

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

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)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 23-0337

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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