Using an online pain management programme to improve recovery and reduce the risk of postsurgical pain after surgery for scoliosis: evaluating the iCanCope Post-Op smartphone app
| ISRCTN | ISRCTN15971722 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15971722 |
- Submission date
- 22/02/2022
- Registration date
- 17/05/2022
- Last edited
- 20/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
20% of adolescents undergoing surgery will develop chronic postoperative pain. Unrelieved or poorly treated postoperative pain can lead to delayed re-mobilization, increased medication use and reduced health-related quality of life, such as sleep, anxiety, social, and school functioning. Psychological variables have been highlighted as risk factors for reporting acute postoperative pain and interventions that address these variables have proven successful in assisting acute postoperative pain management. Smartphone devices with Internet capabilities may improve pain self-management for adolescents with postoperative pain by improving health self-monitoring in everyday environments (e.g., home, school), promoting appropriate self-care (e.g., taking all required medication, ways to cope with pain) and reducing barriers to optimal pain treatment (e.g., lack of transportation to appointments, access to health care providers). A recent review of existing literature found that pain self-management apps available at the moment for patients undergoing surgery lacked (i) goal-setting/social support functions; (ii) comprehensive pain self-management content; (iii) scientific evaluation; and (iv) consultation with end-users in app design. No apps in the review were designed for paediatric patients.
To address this problem, this project seeks to develop and determine the feasibility, and preliminary effectiveness of iCanCope with Post-Operative Pain (or iCanCope PostOp), a self-management smartphone app that provides remote “just-in-time” evidence-based advice to improve pain management and HRQL for adolescents following surgery.
iCanCope with Pain Self-Management Platform: The iCanCope platform is a Canadian smartphone-based (iOS and Android) self-management app for youth with different types of persistent pain (iCanCope.ca). iCanCope includes the core features of: symptom tracking, symptom trends, SMART goal-setting, and a library of pain education and self-management strategies.
The aim of the study is to evaluate the effectiveness of the newly developed iCanCope PostOp smartphone app for reducing preoperative anxiety, improving postoperative pain self-management, reducing the impact of acute postsurgical pain and delivering improved physical and psychological outcomes for adolescents undergoing surgery for scoliosis.
Who can participate?
Adolescents aged 12-18 years who will be undergoing surgery for scoliosis.
What does the study involve?
Once consent/assent has been obtained, participants will be put into one of two groups; the intervention group or the control group. As well as receiving their normal medical treatment, the intervention group will use the iCanCope PostOp smartphone app for 4-10 weeks before surgery and 12 weeks after surgery. The control group will not use the app, receiving just their normal medical treatment. All participants will fill out a series of questionnaires at 5 time points across the study. After the study, both groups will be analyzed to see if using the iCanCope PostOp app was effective in reducing preoperative anxiety and the interference of postoperative pain.
What are the possible benefits and risks of participating?
Benefits - Possible reduction in preoperative anxiety and postoperative pain interference.
Risks - We do not foresee any risks due to taking part in this study.
Where is the study run from?
Centre for Pain Research, School of Psychology, NUI Galway (Ireland)
When is the study starting and how long is it expected to run for?
May 2018 to May 2025
Who is funding the study?
The National Children's Research Centre (Ireland)
Who is the main contact?
Prof. Brian McGuire, brian.mcguire@nuigalway.ie
Contact information
Scientific
Centre for Pain Research
School of Psychology
NUI Galway
Galway.
Galway
H91 EV56
Ireland
| Phone | 091-493266 |
|---|---|
| brian.mcguire@nuigalway.ie |
Public
Centre for Pain Research
School of Psychology
NUI Galway
Galway.
Galway
H91 EV56
Ireland
 ORCID ID |
0000-0001-6245-5156 |
|---|---|
| Phone | +353868600130 |
| paul.p.oreilly@nuigalway.ie |
Study information
| Study design | Multi-centre parallel-group pilot interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Online psychological intervention to promote healthy adjustment and reduce risk of chronic postsurgical pain following surgery for scoliosis: evaluation of iCanCope post-op smartphone app |
| Study acronym | iCC |
| Study objectives | The iCanCope PostOp smartphone app, app intervention, control and outcomes measures can be implemented as planned (fidelity). The iCanCope PostOp smartphone app can reduce anxiety 1-week before surgery, reduce the impact of acute postoperative pain interference and positively impact other key health outcomes – pain intensity, depression, anxiety, sleep and physical function, overall health and school attendance - for 12-18 year old patients undergoing surgery for scoliosis. |
| Ethics approval(s) | 1. Approved 31/12/2018, CHI Crumlin (Cooley Road, Crumlin, Dublin, D12 N512, Ireland; +353 1-4096100; claire.rice@olchc.ie), ref: GEN/688/18 2. Approved 10/12/2019, CHI Temple Street (Temple Street , Rotunda, Dublin 1, D01 XD99, Ireland; +353 1-8784200; lennonje@tcd.ie), ref: 19.047 3. Approved 27/07/2020, Blackrock Clinic (Rock Road, Intake, Blackrock, Co.Dublin, Ireland; +353 1-2832222; aoife.cooke@blackrock-clinic.com), ref: none provided 4. Approval pending, National Orthopaedic Hospital Cappagh (Cappagh Road, Cappoge, Dublin 11, D11 EV29, Ireland; +353 1-8140400; Mary.Byrne@nohc.ie), ref: CAPP/2018/ETH/SH-DCEO-232 5. Approved 03/01/2019, University of Galway (University Road, Galway, H91 TK33, Ireland; 091524411; ethics@universityofgalway.ie), ref: 18-DEC-14 |
| Health condition(s) or problem(s) studied | Reduction of the impact of preoperative anxiety and postoperative pain for adolescents aged 12- 18 yrs undergoing surgery for scoliosis. |
| Intervention | A multi-centre, parallel groups pilot RCT design will be conducted with at least 60 adolescents. Adolescent patients (12-18 years) who are to undergo surgery for scoliosis will be recruited (i) through NUI Galway, School of Psychology and Centre for Pain Research official websites and social media – Facebook and Twitter - Study and research team contact information will be advertised and interested families can make contact. (ii) Local and national press – e.g. Galway Advertiser, iRadio - Study and research team contact information will be advertised and interested families can make contact. (iii) from waiting lists of those scheduled to undergo surgery at a number of collaborating hospitals – (a) Adolescent patients (12-18 years) on waiting lists for scoliosis surgery will be screened by the clinical nurse specialist according to the inclusion and exclusion criteria. Eligible patients and their families will be approached by the clinical nurse specialist, informed of the study and asked if their details can be passed on to the research team. The research team will contact interested patients and their families to provide more details of the study and find out whether they would like to take part in the study. If they agree to take part, consent/assent will be obtained. If families do not wish to agree to take part there and then, they will be given the contact details of the research team and can make contact if they wish to take part. (b) Alternatively, members of the research team will attend the pre-op clinics and eligible patients and their families will be referred to the research team by the clinical nurse specialist, who will explain the study to them in detail. If families agree to take part, consent/assent will be obtained there and then. If families do not wish to agree to take part there and then, they will be given the contact details of the research team and can make contact if they wish to take part. Due to the current COVID-19 restrictions, an optional remote video recruitment meeting - using the WhatsApp platform – is included in the recruitment process. This is to provide a personal introduction to the study in lieu of meeting the family face-to-face. App Instructional/Use Meeting - Patients and their families who agree to take part in the study will receive an ‘app-instructional/use meeting’ by a member of the research team or an on-site clinician at their pre-op visit or at the pre-op clinic. During this introduction, they will be shown how to use the app and guided through the main functions. In lieu of being able to carry out this ‘app-instructional/use meeting’ face-to-face with patients at their pre-op clinic due to COVID-19 restrictions or because no face-to-face contact with participant's has occurred (e.g. recruited via social media), a remote video meeting may be set-up to walk patients through app use and explain the main functions of the app. Similar to the remote video recruitment meeting, this will be done via Whatsapp and will only be carried out if an on-site clinician is not able to run through this with patients. Randomization - Participants will then be randomized into either a control group or an intervention group. Randomization will be conducted securely online using the REDCap secure web application. Following randomization, participants will be instructed on the procedures to be followed within their assigned study group. Intervention Group - In addition to receiving treatment as usual, participants in the intervention group will be given the iCanCope PostOp smartphone app to use before and after surgery. Participants will use the app 4-10 weeks preoperatively and 12 weeks postoperatively. Control Group - Patients in the control group will receive treatment as usual. Descriptive variables will be collected securely online using the REDCap secure web application via questionnaires including sociodemographic characteristics, surgery- related characteristics, pain-related characteristics; adolescent access, use, and comfort level with smartphones. |
| Intervention type | Other |
| Primary outcome measure | 1. Accrual and dropout rates measured using the study enrolment logs throughout the study period, with total rates calculated at study completion. 2. Fidelity measured using the study enrolment logs. We will track any technical or other issues with enrolling participants in the study enrolment loss so we can calculate a rate of successful app onboarding, and measure completion. Tracking of this is done throughout the study and rates are calculated at study completion. 3. Adolescents’ perceptions regarding app acceptability and satisfaction measured using qualitative interviews after the trial has ended. 4. App engagement measured for intervention participants only, using the analytics dashboard. Specifically, we measure the rate of check-in completion, articles read, and goals set. |
| Secondary outcome measures | 1. Pain intensity measured using Pain Intensity Questionnaire at T0, T1, T2, T3 & T4. 2. Pain interference measured using PROMIS Pediatric – Pain Interference at T0, T1, T2, T3 & T4. 3. Pain catastrophizing measured using Pain Catastrophizing Scale Children at T0, T1, T2, T3 & T4. 4. Pain self-efficacy measured using Pain Intensity Questionnaire at T0, T1, T2, T3 & T4. 5. Depression measured using PROMIS Pediatric – Depressive Symptoms at T0, T1, T2, T3 & T4. 6. Anxiety measured using PROMIS Pediatric – Anxiety at T0, T1, T2, T3 & T4. 7. Sleep measured using PROMIS Pediatric – Sleep Disturbance at T0, T1, T2, T3 & T4. 8. Physical function measured using PROMIS Pediatric – Mobility at T0, T1, T2, T3 & T4. 9. Patient’s impressions of recovery using Patient Global Impression of Change at T4. 10. Participants in the intervention group’ acceptability of the iCanCope PostOp app using Acceptability e-Scale at T1 & T4. 11. School attendance measured Health Services, Medication and School Attendance at T2, T3 & T4. T0/Baseline = 6-8 weeks before surgery T1 = 1 week before surgery T2 = 2 weeks after surgery T3 = 4 weeks after surgery T4 = 12 weeks after surgery |
| Overall study start date | 17/05/2018 |
| Completion date | 31/05/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 4. Are able to speak and read English 5. Scheduled to undergo scoliosis surgery |
| Key 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. A diagnosed chronic pain condition not related to the surgical condition |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 31/12/2024 |
Locations
Countries of recruitment
- Ireland
Study participating centres
Crumlin
Dublin
D12 N512
Ireland
Rotunda
Dublin
D01 XD99
Ireland
Intake
Blackrock
Dublin
-
Ireland
Cappoge
Dublin
D11 EV29
Ireland
Sponsor information
University/education
University Road
Galway.
Galway
H91 TK33
Ireland
| Phone | 091 493101 |
|---|---|
| psychology@nuigalway.ie | |
| Website | https://www.nuigalway.ie/colleges-and-schools/arts-social-sciences-and-celtic-studies/psychology/ |
"ROR" |
https://ror.org/03bea9k73 |
Funders
Funder type
Government
Government organisation / Research institutes and centers
- Alternative name(s)
- NCRC
- Location
- Ireland
Results and Publications
| Intention to publish date | 30/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be submitted to suitable publications once analysis is complete. |
| IPD sharing plan | Raw data is not expected to be made available |
Editorial Notes
20/01/2025: The following changes were made to the trial record:
1. The ethics approval (5) was added.
2. The overall end date was changed from 31/01/2025 to 31/05/2025.
22/02/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2023 to 31/12/2024.
2. The overall end date was changed from 31/01/2024 to 31/01/2025.
3. The intention to publish date was changed from 30/06/2024 to 30/06/2025.
4. The plain English summary was updated to reflect these changes.
31/03/2023: The recruitment end date has been changed from 28/02/2023 to 31/12/2023.
29/03/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/03/2023 to 31/01/2024.
2. The intention to publish date was changed from 30/06/2023 to 30/06/2024.
07/06/2022: The public title was changed from 'Using a smartphone to improve recovery and reduce the risk of postsurgical pain after surgery for scoliosis: evaluating the iCanCope post-op smartphone app' to 'Using an online pain management programme to improve recovery and reduce the risk of postsurgical pain after surgery for scoliosis: Evaluating the iCanCope Post-Op smartphone app'.
17/03/2022: Trial's existence confirmed by NUI Galway
