SurgeryNCT05441579
Recruitment and Behavioral Economic Strategies
A study testing Behavioral Economics (BE) recruitment strategies, Biofeedback-based virtual reality (VR-BF) and Manage My Pain in people with Surgery and Adolescent Behavior, run by Vanessa Olbrecht at 1 site in United States.
Trial summary
To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery, Adolescent Behavior
- What is being tested?
- Behavioral Economics (BE) recruitment strategies, Biofeedback-based virtual reality (VR-BF) and Manage My Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2022to 8 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients between the ages of 12-18 years of age
- Patients able to read, understand, and speak English
- Patients undergoing surgery requiring postoperative admission
- Patients undergoing surgery that requires narcotic administration
Who cannot join
- Patients outside of the age range
- Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting)
- History of severe vertigo or dizziness
- History of chronic pain
- Patients that use opioids or benzodiazepines chronically
- Patients with conditions that would preclude placement of a VR headset, including craniofacial abnormalities or undergoing surgeries of the head and neck.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management.
Read the detailed description
Patients will be asked to watch one of two videos in either Phase 1 or Phase 2 relating to recruitment and fill out a survey to determine their likelihood to enroll in a research study. Patients 12-18 years of age presenting for surgery that requires postoperative admission and usually requires narcotic administration.
- Conditions
- Surgery, Adolescent Behavior
- Being tested
- Behavioral Economics (BE) recruitment strategies, Biofeedback-based virtual reality (VR-BF), Manage My Pain
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Economics (BE) recruitment strategiesBehavioural
Behavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment.
Biofeedback-based virtual reality (VR-BF)Other
Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm.
Manage My PainOther
Commercially available and free app to track, analyze and monitor pain.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - VR-BF BE | Experimental | We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. Receives: Behavioral: Behavioral Economics (BE) recruitment strategies; Other: Biofeedback-based virtual reality (VR-BF) |
| Phase 1 - VR-BF Biological | Active comparator | A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. Receives: Other: Biofeedback-based virtual reality (VR-BF) |
| Phase 2 - Manage My Pain BE | Experimental | We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application. Receives: Behavioral: Behavioral Economics (BE) recruitment strategies; Other: Manage My Pain |
| Phase 2 - Manage My Pain Biological | Placebo comparator | A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application. Receives: Other: Manage My Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management.
Survey to identify likelihood to participate in study using a 5-point Likert scale (1="Extremely Unlikely" to 5="Extremely Likely").
Measured: Baseline
Willingness to Participate in Clinical Trial
If given the opportunity, would you participate in the clinical trial?
Measured: Baseline
Secondary outcomes (15)
Intention to Adhere to Therapy - Would Practice
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would practice this technology at least once per day before surgery.
Measured: Baseline
Acceptability of Therapy - Excitement
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would be excited to use this technology.
Measured: Baseline
Perception of Efficacy - Less Pain
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I believe this technology would help me have less pain after surgery.
Measured: Baseline
Perception of Risk - Side Effects
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I am worried that this technology would have a lot of side effects.
Measured: Baseline
Opinion of Treatment Burden - Ease of Use
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I feel that this technology would be easy to use.
Measured: Baseline
Intention to Adhere to Therapy - Would Use
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would use this technology at least once per day after surgery while I was still needing it.
Measured: Baseline
Acceptability of Therapy - Pain Medication
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would like to use this technology to help me take less pain medication.
Measured: Baseline
Acceptability of Therapy - Recommend to Others
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would recommend this therapy to other individuals undergoing surgery.
Measured: Baseline
Acceptability of Therapy - Preference
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would prefer using this technology over taking pain medications.
Measured: Baseline
Perception of Efficacy - Less Pain Medication
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I believe that this technology would help me use less pain medication after surgery.
Measured: Baseline
Perception of Risk - Amount
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I believe that this technology would be too risky for me to use.
Measured: Baseline
Opinion of Treatment Burden - Independence
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would feel comfortable using this technology independently without supervision.
Measured: Baseline
Opinion of Treatment Burden - Familiar
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I am familiar with how to use this type of technology.
Measured: Baseline
Opinion of Treatment Burden - Pay for Technology
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I would pay for the opportunity to use this technology during my recovery.
I am comfortably using technologies like this.
Measured: Baseline
Opinion of Treatment Burden - Technology Comfort
Based on answers to the following survey questions which were assessed along a 5-point Likert scale (from 1="Strongly Disagree" to 5= "Strongly Agree"):
I am comfortably using technologies like this.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start17 May 2022
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Why it stopped: Interim analysis showed no difference between groups
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanessa Olbrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vanessa Olbrecht, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441579
- Sponsor's protocol ID
- STUDY00002413
- Status last verified
- Dec 2024
- First submitted
- 28 Jun 2022
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05441579
- Acronym / sponsor ID
- STUDY00002413
- Conditions
- Surgery, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed no difference between groups
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Vanessa OlbrechtUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 1 Jul 2022 (actual)
- Results
- Posted 20 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management.
Detailed description
Patients will be asked to watch one of two videos in either Phase 1 or Phase 2 relating to recruitment and fill out a survey to determine their likelihood to enroll in a research study. Patients 12-18 years of age presenting for surgery that requires postoperative admission and usually requires narcotic administration.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - VR-BF BE | Experimental | Behavioral: Behavioral Economics (BE) recruitment strategies, Other: Biofeedback-based virtual reality (VR-BF)We are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. |
| Phase 1 - VR-BF Biological | Active comparator | Other: Biofeedback-based virtual reality (VR-BF)A similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. |
| Phase 2 - Manage My Pain BE | Experimental | Behavioral: Behavioral Economics (BE) recruitment strategies, Other: Manage My PainWe are applying Behavioral Economics (BE)-based messaging and presentation strategies to patient recruitment and determining whether these strategies may enhance patient recruitment into a pediatric randomized clinical trial. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application. |
| Phase 2 - Manage My Pain Biological | Placebo comparator | Other: Manage My PainA similar to BE-based recruitment video using a standard biological approach on teenagers' decision to enroll in a clinical study will be used as comparison. Phase 2 will focus on patients that would be enrolled into the control arm of a clinical trial with a control intervention, Manage My Pain application. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients between the ages of 12-18 years of age
- Patients able to read, understand, and speak English
- Patients undergoing surgery requiring postoperative admission
- Patients undergoing surgery that requires narcotic administration
Key exclusion criteria (6 listed)
- Patients outside of the age range
- Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting)
- History of severe vertigo or dizziness
- History of chronic pain
- Patients that use opioids or benzodiazepines chronically
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 |
|---|---|---|
| Behavioral Economics (BE) recruitment strategiesBehavioral economics (BE), a method of economic analysis that applies psychological insights into human behavior to explain economic decision-making, has broad applicability and its techniques offer a novel way that may be applied to try to help enhance study recruitment and enrollment. | Behavioural | Phase 1 - VR-BF BE, Phase 2 - Manage My Pain BE |
| Biofeedback-based virtual reality (VR-BF)Phase 1 will focus on patients that would be enrolled into a biofeedback-based virtual reality (VR-BF) arm. | Other | Phase 1 - VR-BF BE, Phase 1 - VR-BF Biological |
| Manage My PainCommercially available and free app to track, analyze and monitor pain. | Other | Phase 2 - Manage My Pain BE, Phase 2 - Manage My Pain Biological |
Primary outcome
To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management.
Time frame: Baseline
Survey to identify likelihood to participate in study using a 5-point Likert scale (1="Extremely Unlikely" to 5="Extremely Likely").
Willingness to Participate in Clinical Trial
Time frame: Baseline
If given the opportunity, would you participate in the clinical trial?
15 secondary outcomes
Intention to Adhere to Therapy - Would Practice
Time frame: Baseline
Acceptability of Therapy - Excitement
Time frame: Baseline
Perception of Efficacy - Less Pain
Time frame: Baseline
Perception of Risk - Side Effects
Time frame: Baseline
Opinion of Treatment Burden - Ease of Use
Time frame: Baseline
Intention to Adhere to Therapy - Would Use
Time frame: Baseline
Acceptability of Therapy - Pain Medication
Time frame: Baseline
Acceptability of Therapy - Recommend to Others
Time frame: Baseline
Acceptability of Therapy - Preference
Time frame: Baseline
Perception of Efficacy - Less Pain Medication
Time frame: Baseline
Perception of Risk - Amount
Time frame: Baseline
Opinion of Treatment Burden - Independence
Time frame: Baseline
Opinion of Treatment Burden - Familiar
Time frame: Baseline
Opinion of Treatment Burden - Pay for Technology
Time frame: Baseline
Opinion of Treatment Burden - Technology Comfort
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Economics (BE) recruitment strategies, Biofeedback-based virtual reality (VR-BF) and Manage My Pain in people with Surgery and Adolescent Behavior, run by Vanessa Olbrecht at 1 site 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Determine the Impact of the Application of Behavioral Economic Strategies on Recruitment of Pediatric Patients Into a Randomized Clinical Trial Assessing the Impact of Technology-based Interventions on Postoperative Pain Management. (time frame: Baseline). 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 20 Dec 2024.