Preoperative anxiety and postoperative pain for adolescents aged 12- 18 years undergoing surgery for limb reconstruction Surgery
Conditions
Interventions
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 limb reconstruction will be recruited:
Sponsors
National University of Ireland, Galway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 12 to 18 years 2. Own a smartphone compatible with the iCanCope app (iOS or Android) 3. Able to speak and read English 4. Scheduled to undergo limb reconstruction surgery
Exclusion criteria
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. Diagnosed chronic pain condition not related to the surgical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. The researchers will track any technical or other issues with enrolling participants in the study enrolment loss so they 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, the researchers measure the rate of check-in completion, articles read and goals set at study completion | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Ireland
Contacts
Public ContactPaul O'Reilly
Outcome results
None listed