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Набор скоро начнётся NCT06707597

Patient Interaction Effects on Pain, Anxiety, and Comfort After Orthopedic Surgery

Наблюдательное Pain Anxiety Surgery

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: Patient Interaction Group.
Кому может быть актуально
Состояния в реестре: Pain, Anxiety, Surgery. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects of Interaction Among Patients on Pain, Anxiety, and Comfort After Orthopedic Surgery

Обзор

This study aims to evaluate the effects of interaction among patients on pain, anxiety, and comfort after orthopedic surgery.

Подробное описание

Surgical procedures can cause pain and anxiety in patients, affecting their comfort levels. Orthopedic surgeries, in particular, are associated with high pain levels. For example, common orthopedic procedures like total knee and hip replacement can cause patients to experience severe pain on the first-day post-surgery. In modern surgical practices, pain management requires the combined use of both pharmacological and non-pharmacological methods. Additionally, various stressors in the hospital environment-such as the sounds of medical devices and monitors, and crowded hospital rooms-can create extra stress for orthopedic patients, especially those with limited mobility. Another important factor is the interaction among patients in the same environment. The presence of another patient in the same room can affect not only environmental comfort but also, through "emotional contagion," the patient's emotional state. Emotional contagion is defined as the transfer of emotions from one person to another, and this interaction can trigger patients' pain and anxiety levels. Particularly, patients who have undergone similar surgical experiences may share each other's emotions empathetically, thereby increasing pain and anxiety. This study aims to examine the effects of patient interaction in the same room on pain, anxiety, and comfort in orthopedic patients.

The study population will consist of patients who undergo lower and upper extremity surgeries in the orthopedics and traumatology clinic of a state hospital in Turkey. Patients who undergo the same surgical procedure on the same day and stay in the same room postoperatively, or those who are in single rooms, will form the study sample. To obtain reliable results, at least 128 patients will be required, with 64 patients in the group sharing a room and 64 patients in the single-room control group. The goal is to reach this sample size during the planning and implementation phases of the research. Considering a 10% patient dropout rate, 70 patients in the shared room group and 70 patients in the single room group, for a total of 140 patients, will be included in the study. Patients will be grouped according to lower and upper extremity surgeries, and pairs will be formed for placement in the same rooms. Patients discharged within 24 hours will be evaluated during their hospital stay. Additionally, a control group of patients in single rooms will be included to assess the impact of staying in the same room.

Before surgery, the patients' trait anxiety levels will be measured using the State-Trait Anxiety Inventory. After the surgery, once patients are placed in their rooms, pain will be assessed at 1, 4, 8, 12, 16, and 24 hours using the Visual Analog Scale for pain at the surgical site, back, and head/neck. Also, at 1, 8, and 24 hours, their state anxiety and immobilization comfort will be evaluated.

Вмешательства

  • Другое Patient Interaction Group
    No interventions or procedures will be applied to the patients. To evaluate whether the pain, anxiety, and comfort of patients undergoing the same surgical procedure are influenced by each other, the average scale scores of patients in double and single rooms will be compared.

Первичные конечные точки

  • Change from Visual Analog Scale [Срок оценки: Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.]
  • Change from State Anxiety Scale [Срок оценки: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.]
  • Change from Trait Anxiety Scale [Срок оценки: Inpatient admission]
  • Change from Immobility Comfort Scale [Срок оценки: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.]

Критерии участия

Критерии включения

  • To have undergone lower and upper extremity surgery at a state hospital,
  • To be over 18 years of age,
  • To stay in the hospital for at least one night,
  • To agree to participate in the study.

Критерии исключения

  • Patients who undergo emergency surgical procedures,
  • Patients with language barriers, learning difficulties, or cognitive diseases such as dementia that prevent them from completing the questionnaires,
  • Patients with epidural or other catheters,
  • Patients who do not wish to participate in the study will be excluded from the research.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Andersson V, Bergstrand J, Engstrom A, Gustafsson S. The Impact of Preoperative Patient Anxiety on Postoperative Anxiety and Quality of Recovery After Orthopaedic Surgery. J Perianesth Nurs. 2020 Jun;35(3):260-264. doi: 10.1016/j.jopan.2019.11.008. Epub 2020 Mar 5. PMID 32147278
  • Spielberger, C. D. (2010). State-trait anxiety inventory. In The Corsini Encyclopedia of Psychology (pp. 1-1). Wiley.
  • Öner, N, & LeCompte A. (1985). Durumluk-Sürekli Kaygı Envanteri El Kitabı. 2. Baskı. İstanbul: Boğaziçi üniversitesi Yayınları.
  • Tosun B, Aslan O, Tunay S, Akyuz A, Ozkan H, Bek D, Aciksoz S. Turkish Version of Kolcaba's Immobilization Comfort Questionnaire: A Validity and Reliability Study. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Dec;9(4):278-84. doi: 10.1016/j.anr.2015.07.003. Epub 2015 Sep 16. PMID 26724235
  • Caliskan E, Aksoy N. The Relationship Between Preoperative Anxiety Level and Postoperative Pain Outcomes in Total Hip and Knee Replacement Surgery: A Cross-sectional Study. J Perianesth Nurs. 2025 Feb;40(1):76-82. doi: 10.1016/j.jopan.2024.03.010. Epub 2024 Jul 8. PMID 38980235
  • Xu JJ, Tang XT, Fu WC, Zheng JX, Jiang LP, Zhou YW, Yang QN. "Adjacent Bed Effect" of Total Knee Arthroplasty Patients During the Perioperative Period. Pain Manag Nurs. 2024 Feb;25(1):88-92. doi: 10.1016/j.pmn.2023.09.003. Epub 2023 Oct 20. PMID 37867077

Идентификаторы

NCT: NCT06707597 · AEŞH-BADEK-2024-773

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗