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NCT Number: NCT05816174

Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

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.

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Key information

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Basel, Basel, Switzerland

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Chronic postsurgical pain

    Time frame: 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.

  2. Pain trajectories

    Time frame: 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.

  3. Emotion-related trajectories

    Time frame: 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 outcomes

  1. Physical activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Helen Koechlin, PhD

CONTACT

[email protected]

4144 266 83 36

Jana Hochreuter, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Helen Koechlin

Other

Collaborators

  • University of Zurich

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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