Pain, Chronic, Pain, Chronic Post-Surgical
Conditions
Keywords
paediatric chronic pain, post-surgical
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.
Interventions
BEHAVIORALiCanCope 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.
Sponsors
Boston Children's Hospital
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Accrual and Dropout Rates | 12 weeks | This will be centrally tracked by the clinical research project coordinator (CRPC). |
| Engagement with Intervention | 12 weeks | Google Analytics will track patterns of app and website usage. |
| Acceptability and Satisfaction | 12 weeks | 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. |
| Intervention fidelity | 12 weeks | Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the CRPC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | 12 weeks | 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. |
| Overall health | 12 weeks | 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. |
| School attendance | 12 weeks | Self-report, investigator developed |
| Depressive Symptoms | 12 weeks | 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. |
| Pain intensity and interference | 12 weeks | Measured using the short form Brief Pain Inventory (BPI), a 15-item tool that measures pain intensity and impact on functioning. |
| Sleep Functioning | 12 weeks | 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. |
| Physical Function | 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medication utilization | 12 weeks | Self-report, investigator developed (Prescribed and over-the-counter pain medication) |
| Parent Catastrophizing (Parent Outcome) | 12 weeks | 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. |
| Child Surgical Worries | 2 weeks | 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. |
| Health care utilization | 12 weeks | Self-report, investigator developed (Health care visits to various providers, Hospital stay, prescriptions, and admission data from EMR) |
Countries
Canada, United States
Contacts
Primary ContactJennifer Stinson, RN, PhD
Backup ContactChitra Lalloo, PhD
Outcome results
None listed