iCanCope With Post-Operative Pain (iCanCope PostOp)

NCT05382962 | Recruiting

• 1 other identifier: 1000070021
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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

Keywords

paediatric chronic pain; post-surgical

Outcome Measures

Primary Outcomes (4)

• Participant Accrual and Dropout Rates

  This will be centrally tracked by the clinical research project coordinator (CRPC).

  12 weeks

• Intervention fidelity

  Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC.

  12 weeks

• Acceptability and Satisfaction

  Participants in the intervention arm will complete the Acceptability e-scale (AES) post-intervention. In addition, a subset of participants from the intervention group will be offered to participate in a qualitative feedback interview to further explore acceptability and satisfaction of the intervention.

  12 weeks

• Engagement with Intervention

  Google Analytics will track patterns of app and website usage.

  12 weeks

Secondary Outcomes (7)

• Pain intensity and interference

  12 weeks

• Sleep Functioning

  12 weeks

• Physical Function

  12 weeks

• Depressive Symptoms

  12 weeks

• Anxiety

  12 weeks

Other Outcomes (4)

• Medication utilization

  12 weeks

• Health care utilization

  12 weeks

• Child Surgical Worries

  2 weeks

Study Arms (2)

Intervention: iCanCope Post-Op App

EXPERIMENTAL

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).

Behavioral: iCanCope Post Op Application

Control: Usual Care

NO 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).

Interventions

iCanCope Post Op Application BEHAVIORAL

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.

Intervention: iCanCope Post-Op App

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• participated in a previous study of iCanCope PostOp;
• a diagnosed chronic pain condition not related to the surgical condition; or

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Boston Children's Hospital: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Jennifer Stinson, RN, PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Stinson, RN, PhD

CONTACT

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

Chitra Lalloo, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Clinical Nurse Specialist/NP

Model Details: Randomization will be done independently at each site (i.e., SickKids and Boston Children's Hospital), and will be stratified by type of surgery (i.e. pectus repair, scoliosis). Following consent and measure completion, study staff will randomize the participant using a 1:1 randomization allocation to intervention vs. control groups.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 19, 2022
• Study Start: September 28, 2021
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (1); CA (1)