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Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05816174
Enrollment
281
Registered
2023-04-18
Start date
2023-11-01
Completion date
2027-01-01
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post Operative Pain

Brief summary

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.

Interventions

None listed

Sponsors

Helen Koechlin
Lead SponsorOTHER
University of Zurich
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Chronic postsurgical pain3 monthsChronic 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.
Pain trajectories12 monthsDescription 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.
Emotion-related trajectories12 monthsDescription 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.

Secondary

MeasureTime frameDescription
Physical activity3 monthsNumber 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.

Countries

Switzerland

Contacts

CONTACTHelen Koechlin, PhD
helen.koechlin@uzh.ch4144 266 83 36
CONTACTJana Hochreuter, MSc
jana.hochreuter@kispi.uzh.ch
PRINCIPAL_INVESTIGATORHelen Koechlin, PhD

University Children's Hospital, Zurich

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026