Recruitment and Behavioral Economic Strategies

V

Vanessa Olbrecht

Status

Invitation-only

Conditions

Surgery
Adolescent Behavior

Treatments

Behavioral: Behavioral Economics (BE) recruitment strategies
Other: Manage My Pain
Other: Biofeedback-based virtual reality (VR-BF)

Study type

Interventional

Funder types

Other

Identifiers

NCT05441579
STUDY00002413

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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 design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

800 participants in 4 patient groups, including a placebo group

Phase 1 - VR-BF BE
Experimental group
Description:
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.
Treatment:
Other: Biofeedback-based virtual reality (VR-BF)
Behavioral: Behavioral Economics (BE) recruitment strategies
Phase 1 - VR-BF Biological
Active Comparator group
Description:
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.
Treatment:
Other: Biofeedback-based virtual reality (VR-BF)
Phase 2 - Manage My Pain BE
Experimental group
Description:
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.
Treatment:
Other: Manage My Pain
Behavioral: Behavioral Economics (BE) recruitment strategies
Phase 2 - Manage My Pain Biological
Placebo Comparator group
Description:
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.
Treatment:
Other: Manage My Pain

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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