Adolescent Surgery Roadmap Feasibility and Acceptability Study

NCT ID: NCT06991673

Last Updated: 2025-06-05

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2029-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Pediatric Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
The statistician will be masked. The research assistant performing the chart review of the electronic health record will be masked. The PI will be masked, except during the qualitative interviews in which masking would be impossible. Care provider will be masked.

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.

Group Type ACTIVE_COMPARATOR

Behavioral Treatment

Intervention Type BEHAVIORAL

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.

Group Type NO_INTERVENTION

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Positive Activity Exercises

Eligibility Criteria

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Inclusion Criteria

* 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)


* 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 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


* 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
Minimum Eligible Age

12 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Sydney Brown

Assistant Professor of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

University of Michigan affiliated hospitals

Ann Arbor, Michigan, United States

Site Status

Michigan Medicine- Brighton Center for Specialty Care

Brighton, Michigan, United States

Site Status

Countries

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United States

Central Contacts

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Sydney Brown, MD PhD

Role: CONTACT

734-803-3152

Emma Wymer, BA

Role: CONTACT

734-998-4551

Facility Contacts

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Emma Wymer

Role: primary

734-581-1962

Emma Wymer, BA

Role: primary

734-998-4551

Emma Wymer

Role: primary

734-998-4551

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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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