Recruiting

iCanCope PostOp

Sponsor:

The Hospital for Sick Children

Code:

NCT05382962

Conditions

Pain, Chronic

Pain, Chronic Post-Surgical

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

iCanCope Post Op Application

Study Details

Brief summary:

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.

Conditions

Pain, Chronic

Pain, Chronic Post-Surgical

Study ID

NCT05382962

Start date

Sep 28, 2021

Status verified date

Jul, 2025

Completion date

Jan 28, 2026

Anticipated

Primary completion date

Jan 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention: iCanCope Post-Op App

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).

no intervention: Control: Usual Care

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).

Interventions

iCanCope Post Op Application

The iCanCope program is designed to enhance pain self-management and self-efficacy, defined as perception of one's ability to successfully produce a desired effect in a task or behavior affecting their life. The intervention will be delivered on the iOS or Android smartphone platform depending on the participant's device. Usage of app features will be centrally tracked by the research team using Analytics Platform to Evaluate Effective Engagement (APEEE), developed at the Centre for Global eHealth Innovation. Participants will receive alerts through iCanCope to complete a pain diary check-in once per week preoperatively, twice per day over the initial 2-week postoperative period, and once per day for the subsequent 2-week period.

Primary outcome measure

  • Participant Accrual and Dropout Rates [ Time Frame: 12 weeks ]
  • Intervention fidelity [ Time Frame: 12 weeks ]
  • Acceptability and Satisfaction [ Time Frame: 12 weeks ]
  • Engagement with Intervention [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Jennifer Stinson, RN, PhD

416-813-7654jennifer.stinson@sickkids.ca

Chitra Lalloo, PhD

416-813-7654chitra.lalloo@sickkids.ca

Locations

Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Rachel Kelly, BA

416-813-7654rachelr.kelly@sickkids.ca

Chitra Lalloo, BHSc, PhD

416-813-7654chitra.lalloo@sickkids.ca

Principal Investigator:

Jennifer Stinson, RN, PhD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jul 9, 2025

Last verified

Jul, 2025

Keywords

  • paediatric chronic pain
  • post-surgical

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-07-09.