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
1 other identifier
observational
281
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 29, 2026
April 1, 2026
3.2 years
March 30, 2023
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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). This results in a binary outcome: chronic postsurgical pain yes vs no.
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. Higher ratings on the numeric rating scale indicate more pain.
12 months
Emotion-related trajectories
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.
12 months
Secondary Outcomes (1)
Physical activity
3 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helen Koechlinlead
- University of Zurichcollaborator
Study Sites (3)
University Children's Hospital Basel
Basel, Switzerland
University Children's Hospital Zurich
Zurich, 8032, Switzerland
University Hospital Balgrist
Zurich, Switzerland
Related Publications (1)
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.
PMID: 38548365BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Koechlin, PhD
University Children's Hospital, Zurich
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 30, 2023
First Posted
April 18, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04