Orthopedic Surgical ProceduresNCT06707363
Psychological Factors and Pain in Orthopedic Surgery Patients
An observational study of Orthopedic Surgical Procedures, run by Jagiellonian University at 2 sites in Poland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthopedic Surgical Procedures
- What is being tested?
- orthopedic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 170 participants
- Where
- 2 sitesPoland
- Study dates
- 3 Apr 2023to Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- psychiatric disorders: diagnosed psychiatric disorders (e.g., severe depression, anxiety disorders) that are not managed or stable.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Katarzyna Brzezewska, Master's in Psychology contact
Poland2 sites, 2 recruiting
- Recruiting
Stefan Żeromski Specialist Hospital in Krakow, Department of Orthopedic and Trauma Surgery
Krakow, Malopolska, 31-913
Julian Dutka, Professor of medical sciencess, 12 622 92 67, orto.dutka@gmail.com
- Recruiting
Stefan Żeromski Specialist Hospital
Krakow, Malopolska, 31-913
Julian Dutka, Professor of medical sciencess, 12 622 92 67, orto.dutka@gmail.com
About this study
Official title: Psychological Predictors of Pain Experience in Patients After Emergency and Elective Orthopedic Surgery: a Longitudinal Study
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:
- Do psychological factors such as dysfunctional personality traits and emotional regulation explain the experience of pain after surgery and after six months?
- Does the experience of the body mediate the relationship between dysfunctional personality traits and the experience of pain after surgery and after six months?
- Does the experience of pain differ between patients who underwent emergency and elective orthopedic surgery (after surgery and after six months)?
Read more
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.
Read the detailed description
The primary goal of the project is to formulate empirically grounded theses on the association of psychological variables and the type of pain experienced preoperatively on shaping the pain experience among orthopedic patients. Psychological variables, selected based on the literature, include dysfunctional personality traits, emotional regulation, and body image, while the pain experience is understood as the subjective level of pain experienced, pain coping strategies, and pain interference in daily functioning. Additionally, the project aims to compare the pain experience of patients undergoing emergency versus elective orthopedic surgeries in a longitudinal perspective, allowing for consideration of the dynamic nature of pain and its development over time. Orthopedic surgeries are considered among the most painful as they involve significant intervention in both the skeletal system and surrounding soft tissues. Postoperative discomfort often extends beyond acute pain, with 19-22% of orthopedic patients developing chronic pain after surgery. Many orthopedic patients experience reduced mobility and require rehabilitation-their pain experience and associated challenges may be unique. Furthermore, orthopedic surgery is invasive and deeply impacts body boundaries. Therefore, the study also seeks to examine the role of body image (as a mediating variable) in shaping the pain experience.
The research questions addressed will provide recommendations for pain management that highlight the importance of a biopsychosocial perspective, as well as recommendations for developing preventive and therapeutic programs for psychological work with orthopedic patients based on the study's findings.
Plan of the project Phase 1 - Data Collection: This will take place at the Department of Orthopedic and Traumatic Surgery of Żeromski Hospital in Krakow. Physicians will identify eligible patients based on inclusion and exclusion criteria, after which the researcher will seek patient consent for participation. A total of 170 patients aged 18-65 years who underwent elective or emergency orthopedic surgery will participate, completing questionnaires within 72 hours post-surgery. The following tools will be used: The Personality Inventory for ICD-11 (PiCD), Difficulties in Emotion Regulation Scale (DERS), The Pain Coping Strategies Questionnaire (CSQ), Visual analogue scale (VAS), Multidimensional Body Self Relations Questionnaire (MBSRQ), and Pain Interference Scale. Relevant medical information will be collected to control for confounding variables. This phase aims to generate empirical data on selected psychological variables and postoperative pain characteristics.
Phase 2 - Follow-up: This will occur six months postoperatively via online questionnaires, where patients will complete some of the previous questionnaires again. This phase aims to collect empirical data to (1) analyze changes in the pain experience over time and (2) analyze changes in body image and pain coping strategies over time post-surgery.
Data Analysis: Analysis of empirical data in SPSS will include mediation analysis, stepwise regression analysis, and analysis of group mean differences. This will support the following research objectives: (1) identification of psychological variables explaining postoperative pain experience and its changes over time; (2) comparative analysis of pain experiences among emergency versus elective surgery patients; (3) identification of the role of body image as a mediator between psychological variables and pain experience.
Interpretation of Results: Formulating conclusions from the analyses to achieve the main research objective: to empirically establish theses on (a) the impact of psychological variables; and (b) the impact of the type of pain experienced preoperatively on shaping the pain experience among orthopedic patients.
Dissemination of Results: Preparing study results in the form of articles, conference presentations, and popularization efforts to achieve the following research objectives: (1) providing recommendations for pain management that emphasize the need to consider a biopsychosocial perspective, particularly for orthopedic patients; (2) providing recommendations for developing preventive and therapeutic programs for psychological work with orthopedic patients based on the study's findings.
- Conditions
- Orthopedic Surgical Procedures
- Being tested
- orthopedic surgery
- Keywords
- body image, emotional regulation, dysfunctional personality traits, pain experience, orthopedic surgery, subjective pain intensity
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthopedic surgeryProcedure or surgery
Surgeries involving major interventions on the musculoskeletal system, such as joint replacement surgeries or fracture repairs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: orthopedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from 24 to 72 hours after surgery
Secondary outcomes (5)
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.
Measured: 6 months after surgery
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.
Measured: 6 months after surgery
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).
Measured: 6 months after surgery
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.
Measured: 6 months after surgery
Pain interference with daily functioning (6 months 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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start3 Apr 2023
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Orthopedic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Stefan Żeromski Specialist Hospital, Kraków
- Responsible party
- Principal investigator, Katarzyna Brzezewska, Jagiellonian University
- Investigators
- Bernadetta Izydorczyk, Psychology Professor, Study director, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707363
- Sponsor's protocol ID
- KE/3_2023
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * data dictionary (a description of the variables) * demographic data * outcome measures
Publications
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.
PubMed 20832052Khalil 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.
PubMed 32597221Correll D. Chronic postoperative pain: recent findings in understanding and management. F1000Res. 2017 Jul 4;6:1054. doi: 10.12688/f1000research.11101.1. eCollection 2017.
PubMed 28713565Burns 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.
PubMed 25609995
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Predictors of Pain Experience in Patients After Emergency and Elective Orthopedic Surgery: a Longitudinal Study
- ClinicalTrials.gov ID
- NCT06707363
- Acronym / sponsor ID
- KE/3_2023
- Conditions
- Orthopedic Surgical Procedures
- Keywords
- body image, emotional regulation, dysfunctional personality traits, pain experience, orthopedic surgery, subjective pain intensity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Stefan Żeromski Specialist Hospital, Kraków
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do psychological factors such as dysfunctional personality traits and emotional regulation explain the experience of pain after surgery and after six months?
- Does the experience of the body mediate the relationship between dysfunctional personality traits and the experience of pain after surgery and after six months?
- 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.
Detailed description
The primary goal of the project is to formulate empirically grounded theses on the association of psychological variables and the type of pain experienced preoperatively on shaping the pain experience among orthopedic patients. Psychological variables, selected based on the literature, include dysfunctional personality traits, emotional regulation, and body image, while the pain experience is understood as the subjective level of pain experienced, pain coping strategies, and pain interference in daily functioning. Additionally, the project aims to compare the pain experience of patients undergoing emergency versus elective orthopedic surgeries in a longitudinal perspective, allowing for consideration of the dynamic nature of pain and its development over time. Orthopedic surgeries are considered among the most painful as they involve significant intervention in both the skeletal system and surrounding soft tissues. Postoperative discomfort often extends beyond acute pain, with 19-22% of orthopedic patients developing chronic pain after surgery. Many orthopedic patients experience reduced mobility and require rehabilitation-their pain experience and associated challenges may be unique. Furthermore, orthopedic surgery is invasive and deeply impacts body boundaries. Therefore, the study also seeks to examine the role of body image (as a mediating variable) in shaping the pain experience.
The research questions addressed will provide recommendations for pain management that highlight the importance of a biopsychosocial perspective, as well as recommendations for developing preventive and therapeutic programs for psychological work with orthopedic patients based on the study's findings.
Plan of the project Phase 1 - Data Collection: This will take place at the Department of Orthopedic and Traumatic Surgery of Żeromski Hospital in Krakow. Physicians will identify eligible patients based on inclusion and exclusion criteria, after which the researcher will seek patient consent for participation. A total of 170 patients aged 18-65 years who underwent elective or emergency orthopedic surgery will participate, completing questionnaires within 72 hours post-surgery. The following tools will be used: The Personality Inventory for ICD-11 (PiCD), Difficulties in Emotion Regulation Scale (DERS), The Pain Coping Strategies Questionnaire (CSQ), Visual analogue scale (VAS), Multidimensional Body Self Relations Questionnaire (MBSRQ), and Pain Interference Scale. Relevant medical information will be collected to control for confounding variables. This phase aims to generate empirical data on selected psychological variables and postoperative pain characteristics.
Phase 2 - Follow-up: This will occur six months postoperatively via online questionnaires, where patients will complete some of the previous questionnaires again. This phase aims to collect empirical data to (1) analyze changes in the pain experience over time and (2) analyze changes in body image and pain coping strategies over time post-surgery.
Data Analysis: Analysis of empirical data in SPSS will include mediation analysis, stepwise regression analysis, and analysis of group mean differences. This will support the following research objectives: (1) identification of psychological variables explaining postoperative pain experience and its changes over time; (2) comparative analysis of pain experiences among emergency versus elective surgery patients; (3) identification of the role of body image as a mediator between psychological variables and pain experience.
Interpretation of Results: Formulating conclusions from the analyses to achieve the main research objective: to empirically establish theses on (a) the impact of psychological variables; and (b) the impact of the type of pain experienced preoperatively on shaping the pain experience among orthopedic patients.
Dissemination of Results: Preparing study results in the form of articles, conference presentations, and popularization efforts to achieve the following research objectives: (1) providing recommendations for pain management that emphasize the need to consider a biopsychosocial perspective, particularly for orthopedic patients; (2) providing recommendations for developing preventive and therapeutic programs for psychological work with orthopedic patients based on the study's findings.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After orthopedic surgeries | – | Procedure: orthopedic surgeryThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- psychiatric disorders: diagnosed psychiatric disorders (e.g., severe depression, anxiety disorders) that are not managed or stable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orthopedic surgerySurgeries involving major interventions on the musculoskeletal system, such as joint replacement surgeries or fracture repairs. | Procedure or surgery | After orthopedic surgeries |
Primary outcome
Dysfunctional personality traits
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Body image (6 months later)
Time frame: 6 months after surgery
Emotion regulation (6 months after surgery)
Time frame: 6 months after surgery
Subjective pain severity (6 months after surgery)
Time frame: 6 months after surgery
Pain coping strategies (6 months after surgery)
Time frame: 6 months after surgery
Pain interference with daily functioning (6 months after surgery)
Time frame: 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 20832052Khan 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.
- Background: PubMed 32597221Khalil 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.
- Background: PubMed 28713565Correll D. Chronic postoperative pain: recent findings in understanding and management. F1000Res. 2017 Jul 4;6:1054. doi: 10.12688/f1000research.11101.1. eCollection 2017.
- Background: PubMed 25609995Burns 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.
- Individual participant dataSharing planned: Yes. * data dictionary (a description of the variables) * demographic data * outcome measures
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Femoral Neck Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katarzyna Brzezewska, Master's in Psychology contact
Bernadetta Izydorczyk, Psychology Professor study director
Jagiellonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Surgical Procedures, run by Jagiellonian University at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Brzezewska, Master's in Psychology (+48507404038, katarzyna.brzezewska@doctoral.uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysfunctional personality traits (time frame: from 24 to 72 hours after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707363, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.