Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

Study Overview
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Brief Summary
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Chronic postsurgical pain is defined as pain that develops or intensifies following a surgical procedure. After major surgery, around 20% of children and adolescents develop chronic postsurgical pain, and, as part of it, negative consequences on their quality of life. Emotion-related factors such as the variability of emotions, how emotions are regulated, and how well someone is able to differentiate between different emotions have in part been studied in other types of chronic pain. To date, no study examined emotion-related factors in the development and maintenance of chronic postsurgical pain. This observational study includes five assessment time points, one before and four after major surgery, with the goal to identify emotion-related factors that increase or decrease the risk for the development of chronic postsurgical pain.

Official Title
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Child and Parent Emotion-related Risk and Resilience Factors Associated With the Transition From Acute to Chronic Pain After Surgery: A Prospective Longitudinal Study

Conditions
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Chronic Post Operative Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents aged between 8 and 18 years Planned orthopedic surgery requiring in-patient care in one of the participating children's hospitals Able to read and understand German Exclusion Criteria: Serious comorbid health condition (e.g., cancer, severe neurological impairment, chronic illness requiring daily medication) Prior major orthopedic surgery (e.g., prior spine surgery) Parent/caregiver and child not able to read and understand German

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postsurgical pain | Chronic postsurgical pain as defined by the International Association for the Study of Pain, i.e.: greater than minimal pain (pain intensity ≥ 3) on more than 50% of a 7 days period, and impairment in health-related quality of life (score of < 74.9 on the Pediatric Quality of Life Inventory, PedsQL). Proportion of CPSP in our sample. | 3 months | 
| Pain trajectories | Description of pain trajectories over time, i.e., from baseline through FU3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Numeric Rating Scale (NRS) values of pain intensity at each time point. | 12 months | 
| Emotion-related trajectories | Description of emotion-related trajectories over time, i.e., from baseline through FU3 (at 12 months after surgery). We will estimating group-based trajectory models using participants' Visual Analogue Scale (VAS) values of emotional state to calculate emotion differentiation, emotion variability, and emotion regulation at each time point and describe changes over time. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Number of steps taken by patients per day, as measured by an ambulatory, non-invasive activity-monitoring device worn around the wrist. | 3 months |