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Clinical Trials/NCT06077097
NCT06077097
Completed
N/A

Traumatic Events in Childhood, Attachment, Pain Perception, Epigenetic Marks, Quality of Life and Resilience: When Psychological Dimensions Interfere With the Hospital Management of Pain

University of Lorraine1 site in 1 country100 target enrollmentApril 12, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
University of Lorraine
Enrollment
100
Locations
1
Primary Endpoint
Observe the reported pain intensity and pain affect in individuals experiencing chronic pain
Status
Completed
Last Updated
9 months ago

Overview

Brief Summary

In the present research study, aiming to explore the links between several psychological factors and chronic pain, the research seeks to develop an inclusive framework to investigate the role of adverse childhood experiences (ACEs) in patients' pain perception and overall quality of life throughout their pain management programs. Specifically, attachment styles (AS) and pain-related resilience processes are considered as potential mediators of the effectiveness of chronic pain management programs. Additionally, biological measures are proposed to investigate physiological parameters of pain and to further explore the degree of consistency between self-reported measures, ACEs, ASs, chronic stress, and several epigenetic biomarkers.

Detailed Description

One in four French adults suffers from chronic pain (CP), making it one of the main causes of long-term disability and disease burden in France. Despite the various pain management plans, which have brought their share of improvements, CP remains extremely resistant to treatment, and its annual health costs represent a major national problem. Considering that 70% of CP patients remain severely undertreated, managed exclusively by general practitioners and CP specialists, there is an emerging need to implement more effective and cost-efficient interdisciplinary pain management programs, following a biopsychosocial framework for the management of pain. This framework integrates biological, psychological, and social measures and their interactions to highlight an individual's unique pain state. The psychological concept of "adverse childhood experiences" (ACEs) may play a role in the development and maintenance of CP. Researchers point to a frequency-dependent relationship between ACEs and chronic conditions in adulthood, with a higher number of ACEs leading to more severe CP problems in adulthood. However, research is still in its infancy, and it cannot be concluded that there is a causal relationship between ACEs and the development of persistent pain. It is, therefore, essential to consider several factors that may potentially mediate this relationship, such as the psychological concept of adult attachment style. The latter refers to the way relationships with others are formed, shaped in early childhood. Attachment patterns can be characterized along two dimensions: attachment anxiety (worry about the availability of others) and attachment avoidance (discomfort with proximity and interdependence). Insecure attachment patterns (high anxiety and/or avoidance) have been associated with the development of chronic conditions such as fatigue, medically unexplained CP, and migraines. Furthermore, in patients with CP, attachment anxiety is associated with increased pain. Experimental pain studies have also shown a positive relationship between attachment anxiety and pain. In contrast, the results concerning attachment avoidance are contradictory. Attachment patterns are of great importance for the current project, as CP management programs are usually based on patient-to-patient talk groups, and the medical devices are occupied by doctors and carers. Therefore, the medical discourse, as well as the discourse of peers (i.e. other patients), will not have the same impact or importance depending on whether patients have developed secure attachments or not. Based on the evidence presented above, it seems that the psychological constructs of ACEs and attachment may open up new avenues for understanding individual differences in the context of CP management programs. The research is particularly interested in complementing this line of reasoning by investigating individual differences in various epigenetic markers and levels of resilience of individuals to better understand how potentially traumatic life events will have different effects on patients and their treatment effectiveness. The project aims to develop a more inclusive framework to study the role of ACEs in patients' pain perception and overall quality of life throughout their pain treatment, exploring the potential mediating effect of attachment styles, resilience, and deoxyribonucleic acid (DNA) methylation levels. The project is innovative in its assessment of multiple genetic receptors through the application of an ancillary biological study and in its application of a longitudinal research design.

Registry
clinicaltrials.gov
Start Date
April 12, 2023
End Date
December 18, 2024
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University of Lorraine
Responsible Party
Principal Investigator
Principal Investigator

Christine Rotonda

Methodologist/Epidemiologist Head of Research Unit, Pierre Jane Centre

University of Lorraine

Eligibility Criteria

Inclusion Criteria

  • Have a chronic pain syndrome persisting for at least six months
  • Have been referred to a chronic pain management programme at the Centre of evaluation and treatment of chronic pain at the "Belle- Isle" hospital (private hospital in Metz, France) or at the Pain Consultation of the Regional University Hospital of Nancy, France
  • Be between 18 and 65 years old
  • Be able to read and write in French (be able to understand the information and fill in the questionnaires independently)
  • Agree to participate in the project and sign the consent form

Exclusion Criteria

  • Have received pain management in a specialised chronic pain facility (of any kind) during their lifetime
  • Have physical, cognitive and/or linguistic deficiencies that make it impossible to fill in the questionnaires
  • Have a psychiatric history (psychosis type)
  • Have a drug or alcohol dependency
  • Be a protected adult, under guardianship or curatorship
  • Being pregnant or breastfeeding

Outcomes

Primary Outcomes

Observe the reported pain intensity and pain affect in individuals experiencing chronic pain

Time Frame: Baseline. Through study completion, an average of 1 year.

Pain intensity and pain affect will be measured using the Numerical Rating Scale (NRS). The Numerical Rating Scale is typically an 11-point scale, with 0 representing "no pain" and 10 representing "the worst pain imaginable." In the case of pain intensity, higher scores on the NRS indicate worse pain, with 10 being the most severe pain. For pain affect, higher scores on the NRS may indicate more negative affective responses related to pain.

Secondary Outcomes

  • Attachment Styles(Baseline. Through study completion, an average of 1 year.)
  • Assess the Quality of Life of individuals experiencing chronic pain(Baseline. Through study completion, an average of 1 year.)
  • Pain Interference(Baseline. Through study completion, an average of 1 year.)
  • Adverse childhood experiences(Baseline. Through study completion, an average of 1 year.)
  • Pain cognitions(Baseline. Through study completion, an average of 1 year.)
  • Pain resilience(Baseline. Through study completion, an average of 1 year.)

Study Sites (1)

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