HealthyNCT06254898
Use of Incentives for Stressful Medical Procedures
A study of Healthy, run by Jennifer Staab, MS, CCLS at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Jun 2023to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment that negates the use of the outcome tools
- Children younger than 6 years old, or older than 17 years old.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Children's Hospital Colorado Anschutz
Aurora, Colorado, 80045
Children's Hospital Colorado North Campus
Broomfield, Colorado, 80023
Children's Hospital Colorado South Campus
Highlands Ranch, Colorado, 80129
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Child life standard of care, Child life standard of care + incentives provided with conditional agreement., Child life standard of care + incentive provided unconditionally.
- Keywords
- pediatrics, child life, medical procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child life standard of careBehavioural
Standard preparation and support provided to the participant by a Certified Child Life Specialist.
Child life standard of care + incentives provided with conditional agreement.Behavioural
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.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Child life standard of care | Active comparator | Child life standard of care Receives: 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. Receives: 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. Receives: Behavioral: Child life standard of care + incentive provided unconditionally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the intervention/procedure/surgery
Secondary outcomes (1)
Visit Satisfaction Survey
Visit satisfaction survey completed by the accompanying parent.
Measured: Immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start2 Jun 2023
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Staab, MS, CCLS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jennifer Staab, MS, CCLS, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254898
- Sponsor's protocol ID
- 23-0337
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Incentives for Children Undergoing Stressful Medical Procedures
- ClinicalTrials.gov ID
- NCT06254898
- Acronym / sponsor ID
- 23-0337
- Conditions
- Healthy
- Keywords
- pediatrics, child life, medical procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Jennifer Staab, MS, CCLSUniversity, hospital or other
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Child life standard of care | Active comparator | Behavioral: Child life standard of careChild life standard of care |
| Child life standard of care + incentives provided with conditional agreement. | Experimental | Behavioral: Child life standard of care + incentives provided with conditional agreement.Child life standard of care + incentives provided with conditional agreement. |
| Child life standard of care + incentive provided unconditionally. | Experimental | Behavioral: Child life standard of care + incentive provided unconditionally.Child life standard of care + incentive provided unconditionally. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Cognitive impairment that negates the use of the outcome tools
- Children younger than 6 years old, or older than 17 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child life standard of careStandard preparation and support provided to the participant by a Certified Child Life Specialist. | Behavioural | Child life standard of care |
| 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. | Behavioural | Child life standard of care + incentives provided with conditional agreement. |
| 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. | Behavioural | Child life standard of care + incentive provided unconditionally. |
Primary outcome
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.
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.
1 secondary outcome
Visit Satisfaction Survey
Time frame: Immediately after the intervention/procedure/surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Healthy, run by Jennifer Staab, MS, CCLS at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Yale Preoperative Anxiety Scale (mYPAS) (time frame: Immediately after the intervention/procedure/surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.