Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT06991673

Adolescent Surgery Roadmap Feasibility and Acceptability Study

Sponsor: University of Michigan

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

All

Age Range

12 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-07

Completion Date

2029-12

Last Updated

2025-06-05

Healthy Volunteers

Conditions

Pediatric Surgical Procedures

Interventions

BEHAVIORAL

Behavioral Treatment

Positive Activity Interventions within Ane-Roadmap App Positive Piggy Bank - Capture happy moments by mentally savoring them, recording details, and depositing them into a "piggy bank". Open it when you need a boost. Gratitude Diary - Write two unique things daily for which you're grateful. Smile as you record them to enhance gratitude. Savoring - Each day, spend 2-3 minutes fully enjoying two positive experiences. Log them for reflection. Pleasant Activity Scheduling - Plan and engage in enjoyable activities at least twice weekly. Treat them as important appointments. Random Acts of Kindness - Perform five intentional kind acts in a day, four for others and one for yourself. Signature Strengths - Use a personal strength in a new way daily and reflect on its impact. Love Letter - Express deep appreciation to a loved one in a heartfelt letter and share it with them. Engaging with Beauty - Keep a log of beautiful moments in nature, art, or human kindness.

Inclusion Criteria (Adolescent Patient): * 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 * Patient and caregiver must be willing to participate * Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app * Eligible patient is able to sign/assent form * Adolescent-caregiver dyad has at least one risk factor for adverse post-operative pain outcomes based on pre-enrollment screening (e.g., worries about managing pain, return to normal activities, limitations in doing desired activities, trouble with sleep) Inclusion Criteria (Caregiver): * Patient and caregiver must be willing to participate * Caregiver must be providing at least 50% of the patient's postsurgical caregiving * Caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance with institutional guidelines * Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app Exclusion Criteria (Adolescent Patient): * 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) * Scoliosis surgery (due to extended longitudinal relationship with surgeon) * Concurrent participation in another behavioral/self-management intervention trial * Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate Exclusion Criteria (Caregiver): * Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions * Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English * Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate

Locations (3)

Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center

Ann Arbor, Michigan, United States

University of Michigan affiliated hospitals