Psychological Factors and Pain in Orthopedic Surgery Patients
ConditionOrthopedic Surgical Procedures
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorJagiellonian University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age: participants aged 18 years or older;
surgical procedures: individuals scheduled to undergo either emergency or elective orthopedic surgeries, including but not limited to joint replacements (e.g., hip or knee arthroplasty) and fracture repairs;
time after operation: undergoing orthopedic surgery up to 72 hours before the psychological examination;
informed consent: ability to provide informed consent and willingness to participate in the study;
Disqualifiers
psychiatric disorders: diagnosed psychiatric disorders (e.g., severe depression, anxiety disorders) that are not managed or stable.
Trial population
This study focuses on patients who have undergone either emergency or elective orthopedic surgeries, specifically those involving significant interventions on the musculoskeletal system, such as joint replacements or fracture repairs. The source of study participants is Stefan Żeromski Specialist Hospital in Krakow, Department of Orthopedic and Trauma Surgery. The cohort consists of adult participants (aged 18 years and older) who have been informed about the study and provided their consent to participate. This population will include both males and females. Interventions of interest: psychological questionnaires, pain assessment, longitudinal follow-up.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
orthopedic surgery
Procedure/SurgerySurgeries involving major interventions on the musculoskeletal system, such as joint replacement surgeries or fracture repairs.
Treatment groups
170 Participants
are divided into 1 treatment groupGroup A: After orthopedic surgeries1 intervention
Trial outcomes
Primary outcomes
1
Dysfunctional personality traits
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.
Time frame
from 24 to 72 hours after surgery2
Body image 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.
Time frame
from 24 to 72 hours after surgery3
Emotion regulation after sugery
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.
Time frame
from 24 to 72 hours after surgery4
Subjective pain severity 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).
Time frame
from 24 to 72 hours after surgerySecondary outcomes
1
Body image (6 months later)
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.
Time frame
6 months after surgery2
Emotion regulation (6 months 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.
Time frame
6 months after surgery3
Subjective pain severity (6 months 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).
Time frame
6 months after surgery4
Pain coping strategies (6 months 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.
Time frame
6 months after surgerySponsors and contacts
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Jagiellonian University
Lead sponsor
Stefan Żeromski Specialist Hospital, Kraków
Collaborator
Source ClinicalTrials.gov