Understanding the Acute Pain Phenotype in Patients Undergoing Surgery
NCT06466941
Acute Pain, Chronic Post Operative Pain
Boston, Massachusetts, United States
View Trial DetailsNCT Number: NCT05816174
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.
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Request Info8 year–18 year
All sexes
Observational
University Children's Hospital Basel, Basel, Switzerland
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 months
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). This results in a binary outcome: chronic postsurgical pain yes vs no.
Time frame: 12 months
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. Higher ratings on the numeric rating scale indicate more pain.
Time frame: 12 months
Description of emotion-related trajectories over time, i.e., from baseline through Follow-up 3 (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. Higher values for emotional variability indicate broader range of emotional fluctuations around an individual's mean. Emotion differentiation will be calculated by means of intraclass correlations, with high consistency across predefined episodes indicate poorer differentiation.
Time frame: 3 months
Number of steps taken by patients per day, as measured by an ambulatory, non-invasive activity-monitoring device worn around the wrist. Higher number of steps taken suggests more physical activity.
Contact information is provided by the study sponsor or research team.
Helen Koechlin, PhD
CONTACT
Jana Hochreuter, MSc
CONTACT
Helen Koechlin
Other
Child and Parent Emotion-related Risk and Resilience Factors Associated With the Transition From Acute to Chronic Pain After Surgery: A Prospective Longitudinal Study
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