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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05441579
Other study ID # STUDY00002413
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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