Clinical trial NCT05441579: Recruitment and Behavioral Economic Strategies
Official title: Application of Behavioral Economic Strategies to Enhance Recruitment Into a Pediatric Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Adolescent Behavior
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2022-07-01
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Baseline
measure: Willingness to Participate in Clinical Trial
timeFrame: Baseline
Secondary outcomes:
measure: Intention to Adhere to Therapy - Would Practice
timeFrame: Baseline
measure: Acceptability of Therapy - Excitement
timeFrame: Baseline
measure: Perception of Efficacy - Less Pain
timeFrame: Baseline
measure: Perception of Risk - Side Effects
timeFrame: Baseline
measure: Opinion of Treatment Burden - Ease of Use
timeFrame: Baseline
measure: Intention to Adhere to Therapy - Would Use
timeFrame: Baseline
measure: Acceptability of Therapy - Pain Medication
timeFrame: Baseline
measure: Acceptability of Therapy - Recommend to Others
timeFrame: Baseline
measure: Acceptability of Therapy - Preference
timeFrame: Baseline
measure: Perception of Efficacy - Less Pain Medication
timeFrame: Baseline
measure: Perception of Risk - Amount
timeFrame: Baseline
measure: Opinion of Treatment Burden - Independence
timeFrame: Baseline
measure: Opinion of Treatment Burden - Familiar
timeFrame: Baseline
measure: Opinion of Treatment Burden - Pay for Technology
timeFrame: Baseline
measure: Opinion of Treatment Burden - Technology Comfort
timeFrame: Baseline
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References: