Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents
ConditionChronic Post Operative Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-18
SponsorHelen Koechlin
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
3 months2
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.
Time frame
12 months3
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.
Time frame
12 monthsSecondary outcomes
1
Physical activity
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.
Time frame
3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helen Koechlin
Lead sponsor
University Children's Hospital, Zurich
Sponsor institution
University of Zurich
Collaborator
Source ClinicalTrials.gov