Longitudinal Study of Chronic Postsurgical Pain in Children and Adolescents

Sponsor
Helen Koechlin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05816174
Collaborator
University of Zurich (Other)
281
40

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    281 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Sep 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Jan 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. 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). Proportion of CPSP in our sample.

    2. 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.

    3. Emotion-related trajectories [12 months]

      Description of emotion-related trajectories over time, i.e., from baseline through FU3 (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.

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 18 Years
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Helen Koechlin
    • University of Zurich

    Investigators

    • Principal Investigator: Helen Koechlin, PhD, University Children's Hospital, Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helen Koechlin, Senior Researcher, University Children's Hospital, Zurich
    ClinicalTrials.gov Identifier:
    NCT05816174
    Other Study ID Numbers:
    • LORRIS
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 18, 2023