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Pain Management App for Postoperative Pain
N/A
Recruiting
Led By Jennifer Stinson, RN, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing a new app designed to help manage post-operative pain in teenagers.
Who is the study for?
This trial is for teens aged 12-18 who speak English, own a smartphone, and are scheduled for scoliosis or minimally invasive pectus repair surgery. It's not for those with cognitive impairments that prevent app use, involvement in prior iCanCope studies, or chronic pain unrelated to surgery.Check my eligibility
What is being tested?
The study tests the 'iCanCope PostOp' Smartphone app designed to help teenagers manage post-surgical pain at home. The app tracks pain levels, provides information about their surgery and offers real-time advice on managing discomfort.See study design
What are the potential side effects?
Since this intervention involves using an application rather than medication or medical procedures, traditional side effects are not applicable. However, users may experience issues related to usability of the app or psychological impacts from its content.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability and Satisfaction
Engagement with Intervention
Intervention fidelity
+1 moreSecondary outcome measures
Anxiety
Depressive Symptoms
Overall health
+4 moreOther outcome measures
Child Surgical Worries
Health care utilization
Medication utilization
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention: iCanCope Post-Op AppExperimental Treatment1 Intervention
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).
Group II: Control: Usual CareActive Control1 Intervention
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).
Find a Location
Who is running the clinical trial?
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,670 Total Patients Enrolled
1 Trials studying Chronic Postsurgical Pain
420 Patients Enrolled for Chronic Postsurgical Pain
The Hospital for Sick ChildrenLead Sponsor
687 Previous Clinical Trials
6,944,973 Total Patients Enrolled
Jennifer Stinson, RN, PhDPrincipal InvestigatorThe Hospital for Sick Children
3 Previous Clinical Trials
140 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a smartphone that can use the iCanCope app, which works on iOS or Android.You have taken part in a study involving iCanCope PostOp before.You have a long-lasting pain condition that is not related to the surgery you're having.You have been diagnosed with a specific type of spinal curvature or chest wall deformity.You are planning to have surgery to fix a curved spine or a sunken chest.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention: iCanCope Post-Op App
- Group 2: Control: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will this research be able to provide benefits for elderly patients?
"According to the eligibility requirements, potential patients for this trial must be between the ages of 12 and 18. Out of the 858 total clinical trials, this is one of 108 studies for patients under 18 and 750 for patients over 65."
Answered by AI
How many people are being treated with this drug as part of this clinical trial?
"That is correct. The clinical trial is still open and accepting patients. The listing on clinicaltrials.gov was published on September 28th, 2021 and was last updated on May 16th, 2022. The trial is being conducted at 2 locations and needs 60 patients in total."
Answered by AI
If I meet the eligibility requirements, can I join this clinical trial?
"This study is enrolling 60 participants, aged 12 to 18, who have chronic pain. In addition to being aged 12 to 18, patients must be able to speak and read English, be scheduled to undergo scoliosis or minimally invasive pectus repair surgery, own a smartphone compatible with the iCanCope app (iOS or Android), and be diagnosed with adolescent idiopathic scoliosis or pectus carinatum or pectus excavatum."
Answered by AI
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