Recruitment and Behavioral Economic Strategies

Surgery Clinical Trial

Official title:

Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05441579
• Other study ID #: STUDY00002413
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 17, 2022
• Est. completion date: May 2025

Study information

• Verified date: December 2022
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Surgery

Intervention

Behavioral:
• Behavioral Economics (BE) recruitment strategies
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.

Other:
• 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.
• Manage My Pain
Commercially available and free app to track, analyze and monitor pain.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Vanessa Olbrecht

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline