Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

Recruiting

• Conditions: Chronic Post Operative Pain

• Registration Number: NCT05816174
• Lead Sponsor: Helen Koechlin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study First Submitted QC: 2023-04-12
• Study First Posted: 2023-04-18
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic postsurgical pain	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.
Pain trajectories	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.
Emotion-related trajectories	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.

Secondary Outcome Measures

Name	Time	Method
Physical activity	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.

Trial Locations

Locations (3)

University Children's Hospital Basel; 🇨🇭 Basel, Switzerland

University Children's Hospital Zurich; 🇨🇭 Zurich, Switzerland

University Hospital Balgrist; 🇨🇭 Zürich, Switzerland