Adolescent Surgery Roadmap Feasibility and Acceptability Study
NCT ID: NCT06991673
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-31
2029-12-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Positive Activity Interventions + Surveys
Intervention arm participants will complete one of eight positive activities within the Ane-Roadmap App either as individuals or as an adolescent-caregiver team. Positive activities include gratitude journaling, planning positive experiences, savoring, identifying personal strengths, performing acts of kindness, love letters, engaging with beauty, and positive piggy bank. Participants in the intervention group will receive reminders to complete activities as an individual and as an adolescent-caregiver team. Participants will denote with a checkbox whether intervention activities were completed as an individual vs. as an adolescent-caregiver team.
Participants in the control arm will have access to the Ane-Roadmap app, however all intervention activities will be turned off.
Both control and intervention groups will complete daily and weekly surveys via links embedded within the Roadmap app. Reminders will be sent to participants to complete surveys each day.
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.
Surveys Only
Control arm participants will not have access to the positive psychology interventions activities within the Ane-Roadmap app. They will only complete daily and weekly surveys.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
* 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
* 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
* 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
12 Years
99 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Sydney Brown
Assistant Professor of Anesthesiology
Principal Investigators
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Sydney Brown, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center
Ann Arbor, Michigan, United States
University of Michigan affiliated hospitals
Ann Arbor, Michigan, United States
Michigan Medicine- Brighton Center for Specialty Care
Brighton, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HUM00265431
Identifier Type: -
Identifier Source: org_study_id
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