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Идёт набор NCT06707363

Psychological Factors and Pain in Orthopedic Surgery Patients

Наблюдательное Orthopedic Surgical Procedures

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: orthopedic surgery.
Кому может быть актуально
Состояния в реестре: Orthopedic Surgical Procedures. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Psychological Predictors of Pain Experience in Patients After Emergency and Elective Orthopedic Surgery: a Longitudinal Study

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Dysfunctional personality traits [Срок оценки: from 24 to 72 hours after surgery]
  • Body image after surgery [Срок оценки: from 24 to 72 hours after surgery]
  • Emotion regulation after sugery [Срок оценки: from 24 to 72 hours after surgery]
  • Subjective pain severity after surgery [Срок оценки: from 24 to 72 hours after surgery]
  • Pain coping strategies after surgery [Срок оценки: from 24 to 72 hours after surgery]
  • Pain interference with daily functioning (after surgery) [Срок оценки: from 24 to 72 hours after surgery]
  • Socialdemographic and medical data [Срок оценки: from 24 to 72 hours after surgery]
Вторичные конечные точки (5)
  • Body image (6 months later) [Срок оценки: 6 months after surgery]
  • Emotion regulation (6 months after surgery) [Срок оценки: 6 months after surgery]
  • Subjective pain severity (6 months after surgery) [Срок оценки: 6 months after surgery]
  • Pain coping strategies (6 months after surgery) [Срок оценки: 6 months after surgery]
  • Pain interference with daily functioning (6 months after surgery) [Срок оценки: 6 months after surgery]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Польша · 2 центра
  • Stefan Żeromski Specialist Hospital in Krakow, Department of Orthopedic and Trauma Surgery — Krakow
  • Stefan Żeromski Specialist Hospital — Krakow

Публикации

  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06707363 · KE/3_2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗