Clinical trial NCT05382962: iCanCope With Post-Operative Pain (iCanCope PostOp)
Official title: iCanCope With Post-Operative Pain (iCanCope PostOp): Development of a Smartphone-based Pain Self-management Program for Adolescents Following Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Pain, Chronic Post-Surgical
Keywords: paediatric chronic pain
post-surgical
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2022-05-19
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Accrual and Dropout Rates
timeFrame: 12 weeks
measure: Intervention fidelity
timeFrame: 12 weeks
measure: Acceptability and Satisfaction
timeFrame: 12 weeks
measure: Engagement with Intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Pain intensity and interference
timeFrame: 12 weeks
measure: Sleep Functioning
timeFrame: 12 weeks
measure: Physical Function
timeFrame: 12 weeks
measure: Depressive Symptoms
timeFrame: 12 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: Overall health
timeFrame: 12 weeks
measure: School attendance
timeFrame: 12 weeks
Other outcomes:
measure: Medication utilization
timeFrame: 12 weeks
measure: Health care utilization
timeFrame: 12 weeks
measure: Child Surgical Worries
timeFrame: 2 weeks
measure: Parent Catastrophizing (Parent Outcome)
timeFrame: 12 weeks
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Jennifer Stinson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: