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Pain, ChronicNCT05382962

iCanCope With Post-Operative Pain (iCanCope PostOp)

A study testing iCanCope Post Op Application in people with Pain, Chronic and Pain, Chronic Post-Surgical, run by The Hospital for Sick Children at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Pain, Chronic, Pain, Chronic Post-Surgical
What is being tested?
iCanCope Post Op Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
28 Sep 2021to 28 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jennifer Stinson, RN, PhD contact

416-813-7654 ext. 304514

jennifer.stinson@sickkids.ca

Chitra Lalloo, PhD contact

416-813-7654 ext. 302332

chitra.lalloo@sickkids.ca

2 sites in 2 countries

United States1 site, 1 recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Justin Chimoff, 617-877-0014, justin.chimoff@childrens.harvard.edu

    Joe Kossowsky, PhD, MMSc.

    Not yet recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Rachel Kelly, BA, 416-813-7654 ext. 302313, rachelr.kelly@sickkids.ca

    Chitra Lalloo, BHSc, PhD, 416-813-7654 ext. 202332, chitra.lalloo@sickkids.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
iCanCope Post Op Application
Keywords
paediatric chronic pain, post-surgical
Medical subject headings
Chronic Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCanCope Post Op ApplicationBehavioural

    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.

Study groups in NCT05382962
Study groupRoleWhat they receive
Intervention: iCanCope Post-Op AppExperimentalAdolescents 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).
Receives: Behavioral: iCanCope Post Op Application
Control: Usual CareNo interventionAdolescents 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Participant Accrual and Dropout Rates

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

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. Engagement with Intervention

    Google Analytics will track patterns of app and website usage.

    Measured: 12 weeks

Secondary outcomes (7)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. 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."

    Measured: 12 weeks

  7. School attendance

    Self-report, investigator developed

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start28 Sep 2021
  3. Primary completion28 Jan 2026 (estimated)
  4. Study completion28 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382962
Sponsor's protocol ID
1000070021
Status last verified
Jul 2025
First submitted
11 May 2022
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing iCanCope Post Op Application in people with Pain, Chronic and Pain, Chronic Post-Surgical, run by The Hospital for Sick Children at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer Stinson, RN, PhD (416-813-7654 ext. 304514, jennifer.stinson@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Accrual and Dropout Rates (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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