iCanCope With Post-Operative Pain (iCanCope PostOp)

iCanCope With Post-Operative Pain (iCanCope PostOp): Development of a Smartphone-based Pain Self-management Program for Adolescents Following Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic; Pain, Chronic Post-Surgical
• Intervention / Treatment: Behavioral: iCanCope Post Op Application

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Stinson, RN, PhD; Phone Number: 304514 416-813-7654; Email: jennifer.stinson@sickkids.ca
• Study Contact Backup: Name: Chitra Lalloo, PhD; Phone Number: 302332 416-813-7654; Email: chitra.lalloo@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • Recruiting
      • Hospital for Sick Children
      • Contact: Rachel Kelly, BA; Phone Number: 302313 416-813-7654; Email: rachelr.kelly@sickkids.ca
      • Contact: Chitra Lalloo, BHSc, PhD; Phone Number: 202332 416-813-7654; Email: chitra.lalloo@sickkids.ca
      • Principal Investigator: Jennifer Stinson, RN, PhD
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Not yet recruiting
      • Boston Children's Hospital
      • Contact: Justin Chimoff; Phone Number: 617-877-0014; Email: justin.chimoff@childrens.harvard.edu
      • Sub-Investigator: Joe Kossowsky, PhD, MMSc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity and interference	Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning.	12 weeks
Sleep Functioning	Measured with the PROMIS Pediatric Sleep Disturbance - Short Form 4a, a 4-item measure for assessing sleep disturbance. Each item asks the child receiving care to rate the severity of his or her sleep disturbance during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.	12 weeks
Physical Function	Measured using the PROMIS Pediatric Mobility SF, an 8-item questionnaire designed to investigate the general impact that the patient's lower limbs mobility had on their daily activity tasks (such as playing with friends or walking up the stairs). Each item is scored from 1 (not able to do it0 to 5 (with no trouble). As per PROMIS guidelines, raw score is calculated as the sum of each item score. Scale score was calculated from raw score using the PROMIS conversion table.	12 weeks
Depressive Symptoms	Measured using the PROMIS Pediatric Depressive Symptoms SF, an 8-item questionnaire designed to determine how often one is experiencing specific depressive symptoms in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 14 to 70 with higher scores indicating greater severity of depression.	12 weeks
Anxiety	Measured using the PROMIS Anxiety SF, the 13-item questionnaire that assesses the pure domain of anxiety in children and adolescents. Each item asks the child receiving care to rate the severity of his or her anxiety during the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=almost never; 3=sometimes; 4=often; and 5=almost always) with a range in score from 13 to 65 with higher scores indicating greater severity of anxiety.	12 weeks
Overall health	Measured using the Patients Global Impression of Change (PGIC), that reflects a patient's belief about the efficacy of treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."	12 weeks
School attendance	Self-report, investigator developed	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication utilization	Self-report, investigator developed (Prescribed and over-the-counter pain medication)	12 weeks
Health care utilization	Self-report, investigator developed (Health care visits to various providers, Hospital stay, prescriptions, and admission data from EMR)	12 weeks
Child Surgical Worries	Measured using the Child Surgical Worries Questionnaire, a 27-item self-report measure assessing worries caused by hospitalization and surgery. Patients rate how worried they are about various situations, using the following scale: 0=not at all worried, 1=a little worried, 2=moderately worried, 3=considerably worried, 4=extremely worried.	2 weeks
Parent Catastrophizing (Parent Outcome)	Measured using the Pain Catastrophizing Scale - Parent (PCS-P), a 13-item questionnaire concerning the different thoughts and feelings parents may have when their child experiences pain. Items assessing catastrophic thoughts and feelings about their child's pain use a Likert-type 5-point scale (0 = "not at all" to 4 = "extremely"). The PCS-P yields three subscale scores for rumination, magnification, and helplessness, as well as a total score ranging from 0 to 52.	12 weeks

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Boston Children's Hospital
• Investigators: Principal Investigator: Jennifer Stinson, RN, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Estimated): January 28, 2026
• Study Completion (Estimated): January 28, 2026

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 3, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: post-surgical; paediatric chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: 1000070021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No