iCanCope With Post-Operative Pain (iCanCope PostOp)

The Hospital for Sick Children

Status: Enrolling

Conditions: Pain, Chronic; Pain, Chronic Post-Surgical

Treatments: Behavioral: iCanCope Post Op Application

Study type: Interventional

Funder types: Other

Identifiers

NCT05382962

1000070021

Details and patient eligibility

About

There are few applications available in the community to help teenagers manage pain after surgery. The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp), to help children and parents to better manage pain at home after surgery. The app will help keep track of pain, provide information about the teenager's surgery and provides "in-the-moment" advice wherever and whenever the patient needs it.

Full description

More than 80,000 Canadian children undergo surgery each year. Despite evidence-based pain management and clinical standards, moderate to severe postoperative pain in children is common. Inadequate postoperative pain management contributes to poor health outcomes, increased opioid use, and the development of chronic postsurgical pain. Successful postoperative pain management requires regular monitoring and treatment of pain after hospital discharge. Smartphones are nearly ubiquitous, and growing evidence supports their use to overcome barriers to pain care. Computerized clinical decision support systems (CDSS) can improve pain self-management by tracking symptoms over time and offering tailored evidence-informed pain management advice based on standardized algorithms. A comprehensive and sustainable approach is needed to address poorly managed pediatric postoperative pain in the home setting. To address these gaps in care, we are developing "iCanCope with Post-Operative Pain" (or iCanCope PostOp), a smartphone-based CDSS app that provides remote, in-the-moment advice to improve pain and health-related quality of life (HRQL) for adolescents following surgery.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. aged 12 to 18 years;
2. own a smartphone compatible with the iCanCope app (iOS or Android);
3. diagnosed with adolescent idiopathic scoliosis or pectus carinatum or pectus excavatum;
4. are able to speak and read English; and
5. scheduled to undergo scoliosis or minimally invasive pectus repair surgery.

Exclusion criteria

1. 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;
2. participated in a previous study of iCanCope PostOp;
3. a diagnosed chronic pain condition not related to the surgical condition; or

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Intervention: iCanCope Post-Op App

Experimental group

Description:

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).

Treatment:

Behavioral: iCanCope Post Op Application

Control: Usual Care

No Intervention group

Description:

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).