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Adolescent Surgery Roadmap Feasibility and Acceptability Study

NCT06991673 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-06-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Sydney Brown, MD PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06991673 on ClinicalTrials.gov