iCanCope With Post-Operative Pain (iCanCope PostOp)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iCanCope Post Op Application.
- Who it may be relevant to
- Registry conditions: Pain, Chronic, Pain, Chronic Post-Surgical. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
iCanCope With Post-Operative Pain (iCanCope PostOp): Development of a Smartphone-based Pain Self-management Program for Adolescents Following Surgery
Overview
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.
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.
Interventions
- 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 eHeal
Primary outcome measures
- 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]
Secondary outcome measures (7)
- Pain intensity and interference [Time frame: 12 weeks]
- Sleep Functioning [Time frame: 12 weeks]
- Physical Function [Time frame: 12 weeks]
- Depressive Symptoms [Time frame: 12 weeks]
- Anxiety [Time frame: 12 weeks]
- Overall health [Time frame: 12 weeks]
- School attendance [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Canada · 1 center
- Hospital for Sick Children — Toronto
Identifiers
NCT: NCT05382962 · 1000070021