Clinical trial NCT05816174: Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents
Official title: Child and Parent Emotion-related Risk and Resilience Factors Associated With the Transition From Acute to Chronic Pain After Surgery: A Prospective Longitudinal Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Post Operative Pain
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2023-04-18
Enrollment: 281
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants between the ages of 8 and 18 years who have a planned orthopedic surgery in one of the participating hospitals will be approached. Participating hospitals are large Swiss university children's hospital.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Chronic postsurgical pain
timeFrame: 3 months
measure: Pain trajectories
timeFrame: 12 months
measure: Emotion-related trajectories
timeFrame: 12 months
Secondary outcomes:
measure: Physical activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital Basel
city: Zurich
country: Switzerland
facility: University Children's Hospital Zurich
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: University Children's Hospital, Zurich
name: Helen Koechlin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hochreuter J, Dreher T, Hasler CC, Canonica S, Locher C, Held U, Rabbitts J, Koechlin H. Longitudinal Resilience and Risk Factors in Pediatric Postoperative Pain (LORRIS): Protocol for a Prospective Longitudinal Swiss University Children's Hospitals-Based Study. BMJ Open. 2024 Mar 28;14(3):e080174. doi: 10.1136/bmjopen-2023-080174.