Healthy
Conditions
Keywords
pediatrics, child life, medical procedures
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.
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.
Interventions
BEHAVIORALChild life standard of care
Standard preparation and support provided to the participant by a Certified Child Life Specialist.
BEHAVIORALChild 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.
BEHAVIORALChild 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.
Sponsors
Jennifer Staab, MS, CCLS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| modified Yale Preoperative Anxiety Scale (mYPAS) | 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. |
| Visual Scale Self-Report Anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| Visit Satisfaction Survey | Immediately after the intervention/procedure/surgery | Visit satisfaction survey completed by the accompanying parent. |
Countries
United States
Outcome results
None listed