Psychological Factors and Pain in Orthopedic Surgery Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

orthopedic surgery: Surgeries involving major interventions on the musculoskeletal system, such as joint replacement surgeries or fracture repairs.

Study summary

The goal of this observational study is to verify the association of previously underexplored psychological variables on postoperative pain experience and its progression over time in patients undergoing emergency and elective orthopedic surgeries, including both sexes (age range: 18-65). The main questions it aims to answer are:

1. Do psychological factors such as dysfunctional personality traits and emotional regulation explain the experience of pain after surgery and after six months?
2. Does the experience of the body mediate the relationship between dysfunctional personality traits and the experience of pain after surgery and after six months?
3. Does the experience of pain differ between patients who underwent emergency and elective orthopedic surgery (after surgery and after six months)?

Researchers will compare the pain experience of patients undergoing emergency orthopedic surgery to those undergoing elective orthopedic surgery to see if there are significant differences in pain outcomes and recovery trajectories.

Participants will:

* complete psychological questionnairs to evaluate dysfunctional personality traits, emotional regulation, and body image;
* report their subjective pain level and provide information on their coping strategies for managing pain and information about pain interference in everyday functioning;
* engage in follow-up evaluation (6 months after the surgery) to assess the impact of pain on their daily activities and rehabilitation progress and complete some of the questionnaires again.

Eligibility

Primary outcome measure(s)

• Dysfunctional personality traits — from 24 to 72 hours after surgery
  Variable defined as a set of traits describing an excessive (non-adaptive to maintaining health) intensity of basic personality traits. This variable consists of the following components: anankastia, disinhibition, negative affectivity, dissociality, and social isolation. Measurement Tool: The Personality Inventory for ICD-11 (PiCD). The PiCD includes items scored on a Likert scale from 1 to 5, where: 1 indicates the lowest presence of a given trait. 5 indicates the highest presence of a given trait. Higher scores represent a greater intensity of dysfunctional personality traits, reflecting a non-adaptive psychological profile that may influence postoperative outcomes. Maximum possible score is 300.
• Body image after surgery — from 24 to 72 hours after surgery
  Variable defined as a multidimensional construct that includes subjective thoughts, beliefs, feelings, and behaviors related to the body and physical functioning of the individual. Measurement Tool: The Multidimensional Body Self Relations Questionnaire (MBSRQ). This questionnaire consists of multiple subscales, each scored on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). The minimum score on each subscale indicates a lower level of body image satisfaction or awareness. The maximum score indicates a higher level of body image satisfaction or awareness. The maximum possible score is 345.
• Emotion regulation after sugery — from 24 to 72 hours after surgery
  Refers to challenges in the process of modulating emotions to facilitate the achievement of specific goals. Measurement Tool: The Difficulties in Emotion Regulation Scale (DERS). This scale measures various aspects of emotion regulation difficulties across multiple subscales. Scores on each subscale range from 1 (indicating fewer difficulties) to 5 (indicating greater difficulties). Minimum total score: reflects lower levels of emotion regulation difficulties. Maximum total score: indicates higher levels of difficulties in regulating emotions. Maximum possible score is 180.
• Subjective pain severity after surgery — from 24 to 72 hours after surgery
  Subjective pain severity measured by Visual analogue scale (VAS). It takes the form of a horizontal line of 10 centimeters long. The patient draws a vertical line on it indicating the intensity of the pain from 0 (no pain at all) to 10 (worst pain imaginable).
• Pain coping strategies after surgery — from 24 to 72 hours after surgery
  Understood as taking action to minimize pain, reduce its impact on daily functioning, and alleviate emotional tension caused by pain. Measurement Tool: The Pain Coping Strategies Questionnaire (CSQ). This questionnaire assesses the frequency and type of coping strategies used by individuals to manage pain. Scores on individual strategies range from 0 (indicating no use of a specific strategy) to 6 (indicating frequent use). Minimum total score: indicates less use of pain-coping strategies. Maximum total score: reflects greater reliance on coping strategies. Higher scores in adaptive coping strategies (e.g., distraction, cognitive reinterpretation) suggest better pain management outcomes, while higher scores in maladaptive strategies (e.g., catastrophizing) indicate worse outcomes. Maximum possible score is 252.
• Pain interference with daily functioning (after surgery) — from 24 to 72 hours after surgery
  Defined as the level at which pain disrupts daily functioning. Pain interference is measured by 11 questions addressing various areas of life, including rest, physical fitness, mood, household and professional duties, relationships with others, intellectual activities, and sexual activity. Scale: Each question is rated on a 5-point Likert scale (1 = no interference, 5 = extreme interference). Minimum total score: indicates minimal disruption caused by pain. Maximum total score: reflects severe interference in all assessed areas. Higher scores in specific subscales (e.g., mood, physical fitness) suggest greater pain-related challenges in those domains. Maximum possible score is 55.
• Socialdemographic and medical data — from 24 to 72 hours after surgery
  Information such as age, sex, education, occupation, marital status, type of orthopedic surgery, surgical anesthesia, painkillers taken, chronic diseases, previous surgeries, rehabilitation undertaken.

Trial sites (2)

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