Psychological Factors and Pain in Orthopedic Surgery Patients

NCT06707363 | Recruiting

• 1 other identifier: KE/3_2023
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 2

Brief 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:

• 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.

Conditions

Orthopedic Surgical Procedures

Keywords

body image; emotional regulation; dysfunctional personality traits; pain experience; orthopedic surgery; subjective pain intensity

Outcome Measures

Primary Outcomes (7)

• 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.

  from 24 to 72 hours after surgery

• 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.

  from 24 to 72 hours after surgery

• 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.

  from 24 to 72 hours after surgery

• 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).

  from 24 to 72 hours after surgery

• Pain coping strategies 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.

  from 24 to 72 hours after surgery

• Pain interference with daily functioning (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.

  from 24 to 72 hours after surgery

• Socialdemographic and medical data

  Information such as age, sex, education, occupation, marital status, type of orthopedic surgery, surgical anesthesia, painkillers taken, chronic diseases, previous surgeries, rehabilitation undertaken.

  from 24 to 72 hours after surgery

Secondary Outcomes (5)

• Body image (6 months later)

  6 months after surgery

• Emotion regulation (6 months after surgery)

  6 months after surgery

• Subjective pain severity (6 months after surgery)

  6 months after surgery

• Pain coping strategies (6 months after surgery)

  6 months after surgery

• Pain interference with daily functioning (6 months after surgery)

  6 months after surgery

Study Arms (1)

After orthopedic surgeries

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 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.

Procedure: orthopedic surgery

Interventions

orthopedic surgery PROCEDURE

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

After orthopedic surgeries

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;
• language proficiency: proficiency in the language of the questionnaires used in the study (Polish).

You may not qualify if:

• psychiatric disorders: diagnosed psychiatric disorders (e.g., severe depression, anxiety disorders) that are not managed or stable.

Sponsors & Collaborators

• Jagiellonian University: lead
• Stefan Żeromski Specialist Hospital, Kraków: collaborator

Study Sites (2)

Stefan Żeromski Specialist Hospital in Krakow, Department of Orthopedic and Trauma Surgery

Krakow, Malopolska, 31-913, Poland

RECRUITING

Stefan Żeromski Specialist Hospital

Krakow, Malopolska, 31-913, Poland

RECRUITING

Related Publications (4)

• Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.

  PMID: 20832052 BACKGROUND

• Khalil H, Shajrawi A, Dweik G, Zaghmouri A, Henker R. The impact of preoperative pain-related psychological factors on pain intensity post-surgery in Jordan. J Health Psychol. 2021 Dec;26(14):2876-2885. doi: 10.1177/1359105320937067. Epub 2020 Jun 27.

  PMID: 32597221 BACKGROUND

• Correll D. Chronic postoperative pain: recent findings in understanding and management. F1000Res. 2017 Jul 4;6:1054. doi: 10.12688/f1000research.11101.1. eCollection 2017.

  PMID: 28713565 BACKGROUND

• Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.

  PMID: 25609995 BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Interventions

Orthopedic Procedures

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Bernadetta Izydorczyk, Psychology Professor

  Jagiellonian University

  STUDY DIRECTOR

Central Study Contacts

Katarzyna Brzezewska, Master's in Psychology

CONTACT

+48507404038; katarzyna.brzezewska@doctoral.uj.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Psychologist

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 27, 2024
• Study Start: April 3, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

PL (2)