Ane-Roadmap App for Child Surgery

(Ane-Roadmap Trial)

Not yet recruiting at 2 trial locations

Overseen By Sydney Brown, MD PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Developmental delay, Foster children, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mobile app can help adolescents and their caregivers cope better after painful surgeries. The app provides activities aimed at building resilience and improving overall well-being during recovery, considered a form of behavioral treatment. Participants will either use the app for these activities or complete surveys about their pain and recovery experience. Ideal candidates are adolescents aged 12-17 scheduled for surgery at certain Michigan hospitals, willing to try the app with a caregiver, and have concerns about post-surgery pain or activity limitations. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance recovery experiences for future patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a mobile app for post-surgery support, so it's unlikely that your medications would be affected.

What prior data suggests that the Ane-Roadmap app is safe for adolescents undergoing surgery?

Research shows that positive activities, like those in the Ane-Roadmap app, are generally safe. Studies have found that activities such as gratitude journaling, doing kind acts, and savoring moments can increase positive feelings and improve well-being without causing harm. For example, noting acts of kindness daily for a week can increase happiness. These activities aim to lift mood and have been used widely to enhance emotional well-being. No reports of negative effects have emerged, indicating that participants tolerate them well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Ane-Roadmap App for child surgery because it introduces a unique approach of integrating positive psychology activities into the surgical preparation process. Unlike traditional methods that may focus on medical and physical preparations, this app emphasizes mental well-being by encouraging activities like gratitude journaling, savoring, and acts of kindness. These activities are designed to be engaging and supportive, potentially reducing anxiety and improving recovery experiences for both children and their caregivers. Additionally, the app encourages collaboration between adolescents and caregivers, fostering a supportive environment during what can be a stressful time. By focusing on mental and emotional health, this trial aims to explore a new dimension of care that could enhance overall surgical outcomes.

What evidence suggests that the Ane-Roadmap app is effective for supporting adolescents undergoing surgery?

Research shows that certain positive activities can improve mental well-being. Studies have found that activities like keeping a gratitude journal and performing kind acts increase happiness, life satisfaction, and reduce depression. Practicing gratitude, for instance, can enhance positive feelings and diminish negative ones. Engaging in activities like savoring good moments and recognizing personal strengths can also boost mindfulness and emotional involvement. In this trial, participants in the intervention arm will use the Ane-Roadmap App to engage in these positive activities, potentially improving overall well-being for teenagers and their caregivers during recovery from surgery. Participants in the control arm will complete surveys only, without access to the positive activities. ^{1 4 5 6 7}

Who Is on the Research Team?

Sydney Brown, MD PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-17 who are recovering from painful surgeries, along with their caregivers. To join, they must be willing to use the Ane-Roadmap app for resilience-building activities and complete surveys about their recovery experience.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-surgery Recovery

Participants use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing

8-10 weeks

Weekly app usage and surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys on physical and psychological symptoms

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral Treatment

Trial Overview The study tests if a mobile health app called Ane-Roadmap can help young patients and their caregivers during post-surgery recovery. It checks whether participants will enroll in the study, regularly engage with the app's features, and find it helpful.

How Is the Trial Designed?

Group I: Positive Activity Interventions + Surveys Active Control 1 Intervention

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 II: Surveys Only Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. cdn2.psychologytoday.com cdn2.psychologytoday.com/assets/attachments/496/layous-lyubomirsky-in-press.pdf

Mechanisms Underlying the Success of Positive Activity ... or sources of such positive outcomes as having a happy marriage and successful career, living longer, earning more money, and boasting more friends ...

2. researchgate.net researchgate.net/publication/340954458_Positive_Activity_Interventions_Targeted_to_Improve_Depressive_Symptoms

(PDF) Positive Activity Interventions Targeted to Improve ... Psychological Bulletin, 95(3), 542–575. Dunn, E. W., Aknin, L. B., & Norton, M. I. (2008). Spending money on others promotes. happiness. Science ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6437090/

Positive Psychology and Gratitude Interventions The gratitude intervention managed to increase positive affect, subjective happiness and life satisfaction, and reduce negative affect and depression symptoms.

4. formative.jmir.org formative.jmir.org/2023/1/e49806

Mobile Technology to Monitor and Support Health and Well ... ... acts of kindness, signature strengths, love letter, engaging with beauty, gratitude journal, and positive piggy bank activities; Table 1 ...

5. lawyerwellbeing.net lawyerwellbeing.net/wp-content/uploads/2021/03/Savoring.pdf

Savoring Positive Emotions Savoring increases positive emotions (which is one reason it impacts mental health), deepens gratitude, facilitates mindfulness, enhances engagement, and ...

6. positivepsychology.com positivepsychology.com/savoring/

Savoring in Positive Psychology: 21 Tools to Appreciate Life Recording acts of kindness toward others daily over seven days can boost positive emotions. Present-focused savoring interventions.

7. uplift-psych.sites.olt.ubc.ca uplift-psych.sites.olt.ubc.ca/files/2022/01/Wen-Lyubomirsky-Sin-2020-Positive-activity-interventions-targeted-to-improve-depressive-symptoms.pdf

Wen, Lyubomirsky, Sin 2020 Positive activity interventions ... POSITIVE ACTIVITY INTERVENTIONS FOR DEPRESSION. 9 money on themselves. Interestingly, the amount of money spent did not matter—participants who spent $5 on ...