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Идёт набор NCT06080997

Patients' Expectations Before Spinal Surgery

Наблюдательное Expectations Surgery Pain Quality of Life

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Expectations, Surgery, Pain, Quality of Life. Базовые параметры: 18 лет — 100 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
Дания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Patients' Expectations Before, and Their Experiences After Spinal Surgery, Regarding Pain, Rehabilitation and Quality of Life

Обзор

With this study the investigators want to perform a prospective observational cohort study at Zealand University Hospital, Koege, Denmark. The purpose of this study is twofold: 1. to investigate how expectations predict patients' pain, rehabilitation and quality of life after spinal surgery. 2. to explore the patients' expectations before, and their experiences after, spinal surgery regarding pain, rehabilitation and quality of life.

Подробное описание

Background Surgery can be an overwhelming and often life-changing experience for patients. To mitigate this experience a patient-centered approach can be beneficial. Patient-centered care is defined as providing care that is "respectful of and responsive to individual patient preferences, needs and values, and which ensures that patient values guide all clinical decisions". Patient-centeredness should be considered in discussions about the value of surgical treatment for the patient and the expectations regarding the process of postoperative rehabilitation, especially considering the patient's definition of a successful outcome. The meaning of rehabilitation may vary between stakeholders involved in surgery, including patients, surgeons, anaesthetists, nurses, and hospital administrators. Studies addressing strategies to improve rehabilitation, such as minimally invasive surgery and enhanced recovery pathways, commonly focus on measures such as complication rates, gastrointestinal activity, physical function, and duration of hospital stay. These parameters are mostly relevant to clinicians and administrators, but they do not reflect the complexity of the rehabilitation process or include the patient's perspective and expectations.

In musculoskeletal practice, patients' expectations have been reported as a valuable predictor for treatment outcomes in patients with acute and chronic pain. Patients with higher expectations regarding the treatment report better outcomes than those with lower expectations. Previous studies have investigated the relationship between expectations and postoperative satisfaction in patients undergoing spinal surgery, and some evidence suggests patients' expectations also impact rehabilitation after surgery.

Patients undergoing spinal surgery usually suffer from moderate to severe pain during the perioperative and postoperative period, which is associated with developing persistent pain 8 and compromises patients' quality of life.

Lumbar disc herniation is one of the most common musculoskeletal diseases which, in some cases, can compromise patients' quality of life, and the most common operations performed on the spine. A previous study has shown that persistent pain after surgery for lumbar disc herniation is negatively associated with psychological and physical well-being, and the overall quality of life is decreased.

This study hypothesize that interviewing patients in a semi-structured manner would give unique perspectives on what is important to patients, as opposed to what is important to researchers. Further, the study hypothesize that patients' preoperative expectations for spinal surgery can affect postoperative rehabilitation. Gaining an in-depth understanding of the process of recovery from the patient´s perspective can, ultimately, guide patient-centered care and future research.

Первичные конечные точки

  • Expectations [Срок оценки: Outcome measure will be assessed and presented 2025]
  • Patients Expectations [Срок оценки: Outcome measure will be assessed and presented 2025]
Вторичные конечные точки (3)
  • Patients pain intensity [Срок оценки: Outcome measure will be assessed and presented 2025]
  • Patients functional level [Срок оценки: Outcome measure will be assessed and presented 2025]
  • Quality of life score [Срок оценки: Outcome measure will be assessed and presented 2025]

Критерии участия

Критерии включения

Patients undergoing elective spinal surgery. Patients able to read and understand Danish.

Критерии исключения

Patients with cognitive deficits, such as dementia. Patients with alcohol and drug dependence.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 1 центр
  • Zealand University Hospital — Køge

Публикации

  • Rajabiyazdi F, Alam R, Pal A, Montanez J, Law S, Pecorelli N, Watanabe Y, Chiavegato LD, Falconi M, Hirano S, Mayo NE, Lee L, Feldman LS, Fiore JF Jr. Understanding the Meaning of Recovery to Patients Undergoing Abdominal Surgery. JAMA Surg. 2021 Aug 1;156(8):758-765. doi: 10.1001/jamasurg.2021.1557. PMID 33978692
  • Lee L, Tran T, Mayo NE, Carli F, Feldman LS. What does it really mean to "recover" from an operation? Surgery. 2014 Feb;155(2):211-6. doi: 10.1016/j.surg.2013.10.002. Epub 2013 Oct 12. No abstract available. PMID 24331759
  • Mohamed Mohamed WJ, Joseph L, Canby G, Paungmali A, Sitilertpisan P, Pirunsan U. Are patient expectations associated with treatment outcomes in individuals with chronic low back pain? A systematic review of randomised controlled trials. Int J Clin Pract. 2020 Nov;74(11):e13680. doi: 10.1111/ijcp.13680. Epub 2020 Sep 7. PMID 33166045
  • Krauss P, Sonnleitner C, Reinartz F, Meyer B, Meyer HS. Patient-Reported Expectations, Outcome and Satisfaction in Thoracic and Lumbar Spine Stabilization Surgery: A Prospective Study.Surgeries 2020; 1: 63-76.
  • Werner MU, Mjobo HN, Nielsen PR, Rudin A. Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0. PMID 20460988
  • Frisaldi E, Shaibani A, Benedetti F. Why We should Assess Patients' Expectations in Clinical Trials. Pain Ther. 2017 Jun;6(1):107-110. doi: 10.1007/s40122-017-0071-8. Epub 2017 May 5. PMID 28477082
  • Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3. PMID 23392233
  • Gulur P, Nelli A. Persistent postoperative pain: mechanisms and modulators. Curr Opin Anaesthesiol. 2019 Oct;32(5):668-673. doi: 10.1097/ACO.0000000000000770. PMID 31343465

Идентификаторы

NCT: NCT06080997 · EXP - jzc - 2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗