Pain Management App for Postoperative Pain

Recruiting at 1 trial location

Overseen By Jennifer Stinson, RN, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Cognitive impairment, Chronic pain, others

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

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help teenagers manage post-surgery pain using a smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp). The app tracks pain, provides surgery details, and offers real-time advice for managing discomfort at home. Participants will be divided into two groups: one will use the app alongside their usual care, while the other will receive only the usual care. The trial seeks teenagers aged 12 to 18 who have a smartphone and are scheduled for scoliosis or certain chest surgeries. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management solutions for teenagers.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider.

What prior data suggests that the iCanCope Post-Op App is safe for managing postoperative pain in teenagers?

Research shows that the iCanCope Post-Op app is specifically designed for children and teenagers, incorporating their input to ensure safety and ease of use.

The app allows users to track their pain and provides advice on managing it after surgery. As a digital tool, it avoids the physical side effects associated with medication. Studies suggest that apps like this can safely assist in pain management, and since it involves no physical procedures, reports of negative effects are absent.

Overall, early feedback indicates that the app could be a helpful and safe way to manage pain at home after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional pain management options for postoperative pain that often rely on medications like opioids or NSAIDs, the iCanCope Post-Op app offers a digital, non-pharmacological approach. This app empowers adolescents with tools to manage their pain through personalized strategies and self-monitoring, potentially reducing the need for medication. Researchers are excited about this treatment because it could offer a safer, side-effect-free alternative that also promotes self-efficacy and engagement in the recovery process.

What evidence suggests that the iCanCope Post-Op app is effective for managing postoperative pain in teenagers?

Research shows that the iCanCope PostOp app, which participants in this trial may receive, helps manage pain after surgery. Designed with feedback from real users, it is practical and easy to use. Studies indicate that the app can reduce anxiety before surgery and lessen pain afterward. By offering real-time advice and tracking pain levels, it leads to better pain management and recovery. The app aims to improve outcomes by reducing the need for opioids and preventing long-term pain problems. ^{1 2 3 6 7}

Who Is on the Research Team?

Jennifer Stinson, RN, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for teens aged 12-18 who speak English, own a smartphone, and are scheduled for scoliosis or minimally invasive pectus repair surgery. It's not for those with cognitive impairments that prevent app use, involvement in prior iCanCope studies, or chronic pain unrelated to surgery.

Inclusion Criteria

Are able to speak and read English

You have a smartphone that can use the iCanCope app, which works on iOS or Android.

You have been diagnosed with a specific type of spinal curvature or chest wall deformity.

Exclusion Criteria

Significant cognitive impairment or other co-existing medical condition that could limit the ability to use the iCanCope app, as identified by their health care provider

You have taken part in a study involving iCanCope PostOp before.

You have a long-lasting pain condition that is not related to the surgery you're having.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

6-8 weeks

Pre-operative appointments

Pre-operative

Participants complete measures at pre-operative appointments following consent and randomization

1 week

1 visit (in-person)

Post-operative

Participants use the iCanCope PostOp app and receive usual care, with measures taken at 2-week and 4-week post-op

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with measures taken at 12-week post-op

8 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• iCanCope Post Op Application

Trial Overview

The study tests the 'iCanCope PostOp' Smartphone app designed to help teenagers manage post-surgical pain at home. The app tracks pain levels, provides information about their surgery and offers real-time advice on managing discomfort.

How Is the Trial Designed?

Group I: Intervention: iCanCope Post-Op App Experimental Treatment 1 Intervention

Adolescents randomized to the intervention group will receive the iCanCope PostOp app, in addition to usual care. Both groups will complete measures at pre-operative appointments following consent and randomization (6-8 weeks prior to surgery, T0), at 1-week pre-op (T1), 2-week post-op, (T2) and 4-week post-op (T3), and 12-week post-op (T4).

Group II: Control: Usual Care Active Control 1 Intervention

Adolescents randomized to the control group will receive usual care. Both groups will complete measures at pre-operative appointments following consent and randomization (6-8 weeks prior to surgery, T0), at 1-week pre-op (T1), 2-week post-op, (T2) and 4-week post-op (T3), and 12-week post-op (T4).

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05382962

iCanCope With Post-Operative Pain (iCanCope PostOp)

Inadequate postoperative pain management contributes to poor health outcomes, increased opioid use, and the development of chronic postsurgical pain. ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31008704/

iCanCope PostOp: User-Centered Design of a Smartphone ...

Phase 2 led to the successful and efficient generation of a complete preliminary pain care algorithm for the iCanCope PostOp app, including ...

3.

formative.jmir.org

formative.jmir.org/2019/2/e12028/citations

iCanCope PostOp: User-Centered Design of a Smartphone ...

An Interactive Pain Application (MServ) Improves Postoperative Pain Management. ... Effectiveness of a Persuasive Time Management Mobile App.

4.

isrctn.com

isrctn.com/ISRCTN83484998

Using a smartphone to improve recovery and reduce the ...

The iCanCope PostOp smartphone app can reduce anxiety 1 week before surgery, reduce the impact of acute postoperative pain interference and positively impact ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6658275/

iCanCope PostOp: User-Centered Design of a Smartphone ...

This paper presents an overview of the user-centered design process in developing “iCanCope with Postoperative Pain” (iCanCope PostOp), a smartphone-based app ...

6.

trialx.com

trialx.com/clinical-trials/listings/260101/icancope-with-post-operative-pain-icancope-postop/

iCanCope With Post-Operative Pain (iCanCope PostOp)

The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called " ...

7.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S2451865421001836

Implementation of the iCanCope

The. ICC mobile application provides personalized goal setting to improve pain and function, CBT- based pain self-management training and rehearsal, and peer- ...