Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Memory Biases |
Youth and parents will complete telephone memory interviews to assess their pain memories. Specifically, youth will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain experienced after the surgery. Parents will be asked to remember the levels of sensory (pain intensity) and affective (unpleasantness, anxiety) pain they think their children experienced after the surgery. At the beginning of the memory interviews, children and parents will be asked to freely recall anything that they can remember about the pain task. Telephone interviews to assess children's memory for pain have been effectively conducted with youth. Positively biased pain memories will be defined as recalled pain level that is less than the initial pain report. Accurate memories reflect no difference between recalled and experienced pain. Free recall will be coded for both content and tone. |
4 weeks post-operative (for spinal instrumentation surgeries) - 6 weeks post operative (for pectus chest wall surgeries) |
|
Secondary |
Sleep Quality - Child |
The 10-item short-form of the Adolescent Sleep Wake Scale (ASWS) will be used to assess sleep quality in youth. The ASWS assesses sleep quality along 3 dimensions: Falling asleep and reinitiating sleep, returning to wakefulness, and going to bed. This measure has good reliability and validity in youth with chronic pain. Post-surgical sleep quality will be assessed using an NRS (0 = extremely poor sleep, 10 = extremely good sleep). |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Sleep quality - Parent |
Parent quality of sleep over the last month will be assessed using a well-validated and widely used Pittsburgh Sleep Quality Index (PSQI). Nineteen items comprise seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are summed to yields the global score. The PSQI is reliable and valid. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Pain Intensity |
Youth will rate their pain intensity an 11-point NRS (0 - no pain; 10 - worst pain possible). NRSs are a valid and reliable tool to assess pain intensity in youth.35,36 Average pain scores will be computed for each assessment period. The NRS will be included in the memory interviews but framed in terms of recall of pain. Parents will use the same scale to assess their child's pain. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative) |
|
Secondary |
Pain characteristics, unpleasantness, and interference. |
The 7-item Pain Questionnaire assesses pain frequency, location, duration, intensity, distress, and interference. The pain unpleasantness item is rated on a 5-point Likert scale assessing how much pain bothered the child. Pain interference will be measured using the pain interference subscale of the PROMIS-25 Profile. The subscale's four items are rated on a 5-point Likert scale and assess the extent of everyday impairment due to pain. The scale has excellent psychometric properties and has been used in youth with chronic pain. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Pain-related anxiety. |
Anticipatory and experienced pain-related anxiety related to the pre- and post-surgical pain will be assessed using an 11-point NRS (0 = "not anxious/nervous", 10 = "extremely nervous or anxious") (child and parent report). Similar scales have been used in previous research on children's pain. This measure will be included in the memory interviews but framed in terms of recall. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries), telephone interview (6 weeks post operative) |
|
Secondary |
Post-traumatic stress disorder symptoms - Child |
The 27-item Child PTSD Symptom Scale (CPSS-V) will be used to assess PTSD symptoms according to DSM-5 diagnostic criteria. Twenty symptoms are rated on a 4-point Likert scale; 7 impairment items are rated as present or absent. Total and cluster specific symptom scores and impairment scores are yielded. The CPSS-5 is based on the CPSS-4, which has excellent psychometric properties. We used this scale in our pilot research. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Anxiety and depressive symptoms - child |
Youth anxiety and depressive symptoms will be assessed using the PROMIS-25 Pediatric profile, one of the Pediatric Profile instruments developed by the National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS). Twenty-five items of the measure assess anxiety and depressive symptoms, physical function mobility, fatigue, peer relationships, pain interference, and pain intensity on a 5-point Likert scales. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Physical and psychosocial functioning. |
The 15-item Pediatric Quality of Life Scale (PedsQL) assesses health-related physical, emotional, social, and school functioning using a 5-point Likert scale. The PedsQL is widely used in illness and healthy samples and has excellent psychometric properties. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Sensitivity to pain traumatization (Child version). |
This 12-item Sensitivity to Pain Traumatization Scale - Child version (SPTS-C) has been developed based on the adult version of the scale (SPTS) to assess anxiety-related reactions to pain that are similar to symptoms of posttraumatic stress disorder. The items are rated on a 5-point Likert scale, a higher total score indicates a higher level of sensitivity to pain traumatization. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Catastrophic thinking about pain - Trait (Child) |
Catastrophizing Scale-Child Version (PCS-C) is a 13-item measure assessing children's catastrophic thoughts and feelings about their pain. Items are rated on a 5-point Likert scale. Among youth with pain, the PCS-C has good validity and reliability. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Catastrophic thinking about pain - State (Child version). |
During first days after surgery (until discharge) youth will be asked to rate six statements on an 11-point NRS ("not at all" and "a lot" anchors). The statements correspond to the three PCS-C subscales, i.e., rumination, magnification, helplessness, and adapted from the PCS-C. |
assessment will take place on day 1 post-operative (day after surgical procedure), day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative (if applicable - not yet discharged) |
|
Secondary |
Parent responses to child pain. |
The 26-item Adult Responses to Children's Symptoms (ARCS) with a pain-specific stem will be used to assess parents' responses to child pain complaints. Frequency of behaviours is rated on a 5-point Likert scale. This measure is both valid and reliable. Protect scale of the ARCS will be completed by parents every day post-surgery up to discharge. |
assessment will take place on day 1 post-operative (day after surgical procedure), day 2 post-operative, day 3 post-operative, day 4 post-operative, day 5 post-operative (if applicable - not yet discharged) |
|
Secondary |
Background variables collected at baseline - child age |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
collected at baseline |
|
Secondary |
Pain characteristics, unpleasantness, and interference (Subscale) |
The subscale's four items are rated on a 5-point Likert scale and assess the extent of everyday impairment due to pain. The scale has excellent psychometric properties and has been used in youth with chronic pain. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Post-traumatic stress disorder symptoms - Parent |
Parents' PTSD symptoms will be assessed using the 20-item PTSD Checklist for DSM-5 (PCL-5) with an extended Criterion A and a Life Events Checklist. Response options are rated on a 4-point Likert scale. Total symptom severity and cluster-specific scores are obtained. The measure is valid and reliable. We used this measure in our pilot research on PTSD and chronic pain in youth and parents. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Sensitivity to pain traumatization (Parent version). |
The 12-item Sensitivity to Pain Traumatization Scale - Parent version (SPTS-P) has been developed based on the adult version of the scale (SPTS) to assess parental anxiety-related reactions to pain in their children that are similar to symptoms of posttraumatic stress disorder. The items are rated on a 5-point Likert scale, a higher total score indicates a higher level of sensitivity to pain traumatization. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Catastrophic thinking about pain - Trait (Parent) |
The Pain Catastrophizing Scale-Parent Version (PCS-P) is a 13-item self-report measure assessing catastrophic thoughts and feelings that parents may have when their child experiences pain. Items on the PCS-P are rated on a 5-point Likert scale. The PCS-P is both valid and reliable among parents of youth with and without chronic pain. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Catastrophic thinking about pain - State (Parent version). |
Parents will be asked to rate six statements on an 11-point NRS ("not at all" and "a lot" anchors). The statements correspond to the three PCS-P subscales, i.e., rumination, magnification, helplessness, and adapted from the PCS-P. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Anxiety and depressive symptoms - Parent |
Parents' anxiety and depressive symptoms will be assessed using the PROMIS-29 profile, an adult version of PROMIS-25 profile assessing the same areas of functioning. |
At baseline, in hospital assessment (1-5 days after surgery), 1 week post surgery (for spinal instrumentation surgeries) - 2 weeks post surgery (for pectus chest wall surgeries) |
|
Secondary |
Background variables collected at baseline - parent age |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variable collected at baseline - parent sex |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - child sex |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - child school status |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - parent race |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - child race |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - parent marital status |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - child marital status |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - child education |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - parent education |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|
Secondary |
Background variables collected at baseline - family income |
Parents will complete a questionnaire reporting on demographic characteristics of themselves and their children including: age, sex, school status (e.g., attendance, specialized programming such as an individualized program plan [IPP]), race, marital status, education, and family income. We will request a copy of an IPP from those participants who have it. It will be used to further understand contextual support systems that is available to youth. |
Collected at baseline |
|