Adolescent Surgery Roadmap Feasibility and Acceptability Study
ConditionPediatric Surgical Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-99
SponsorUniversity of Michigan
About this trial
The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. The main questions it aims to answer are:
* Can adolescent surgery patients and their caregivers be successfully enrolled in the study, with at least 40% of those invited choosing to participate? * Will participants actively use the mobile app, completing at least two activities per week for at least half of the study period, either individually and/or as a caregiver-adolescent pair?
Participants will:
* Use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing * Use the app either individually or together as a caregiver-adolescent pair. * Complete surveys regarding risk factors for adverse postsurgical pain outcomes and physical and psychological symptoms experienced postoperatively * Some participants will complete a semi-structured interview in which experiences with the study and intervention activities will be elicited
Eligibility criteria
Qualifiers
Patient is aged 12-17 years on the date of surgery
Surgery is a scheduled surgery (non-emergency)
Surgery is occurring within the University of Michigan hospital system (University Hospital, C.S. Mott Children's Hospital, Brighton Ambulatory Surgery Center, East Ann Arbor Ambulatory Surgery Center)
Participants are able to enroll within 1-2 weeks of surgery
Disqualifiers
Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English
Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions
Foster children or wards of the state are not eligible for inclusion
Hardware removal or debridement surgery (not considered as painful as other orthopedic surgeries)
Trial design
Treatments tested in this trial
- Behavioral Treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov