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Набор скоро начнётся NCT07231562

The Effect of Mobilization Training Given to Patients Undergoing Lumbar Stabilization Surgery on Postoperative Pain, Anxiety, Kinesiophobia, Fear of Falling, and Mobility

Без фазы С лечением Lumbar Disease Lumbar 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: The group that will receive mobilization training using virtual reality glasses and brochures.
Кому может быть актуально
Состояния в реестре: Lumbar Disease, Lumbar 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

In this study, the researcher will examine the effects of preoperative mobilization training (video viewing with VR glasses and brochure methods) given to patients undergoing surgery in the lumbar region on pain, anxiety, fear of movement, fear of falling, and mobility levels in the postoperative period, using specific scales.

Подробное описание

Conditions requiring surgical intervention in the lumbar region include various pathological conditions such as lumbar disc herniation, spinal cord tumors, traumatic spinal injuries, and spinal stenosis. Surgical interventions such as stabilization, fusion, laminectomy, and discectomy are commonly performed for these conditions. The study is a randomized controlled comparative study. The study sample will consist of patients admitted to the Neurosurgery-I and Neurosurgery-II clinics of Eskişehir City Hospital before surgery and transferred back to the clinic after surgery. The study sample is planned to include 60 patients in the intervention group and 60 in the control group. Pre-test data will be collected in the preoperative period from patients in the intervention and control groups who agreed to participate in the study in accordance with the informed consent form and gave their consent using the Informed Consent Form, the Patient Information Form, the State-Trait Anxiety Scale, the Tampa Kinesiophobia Scale, the Likert-Type Fear of Falling Scale, the Visual Analog Scale, the Patient Mobility Scale, and the Observer Mobility Scale. Afterwards, patients in the intervention group will be trained on mobilization by watching a video using VR headsets and using a brochure. Patients in the control group will not receive any video or brochure training other than during the routine mobilization process in the ward. The brochure given to the intervention group will include mobilization and information included in the video viewing using VR headsets and will be given to patients so they can open and read it at any time. During the first mobilization of patients in the intervention and control groups, a "Patient Information Form" will be filled out before mobilization. Data will be collected again using the "State-Trait Anxiety Scale," "Tampa Kinesiophobia Scale," "Likert-Type Fear of Falling Scale," and "Visual Analog Scale." Patients in the intervention group will then be mobilized appropriately using a video and brochure training program shown through virtual reality glasses regarding the mobilization steps. Patients in the control group will be mobilized using the mobilization steps routinely performed in the ward. After the initial mobilization of patients in both groups, data will be collected and recorded again using the "Visual Analog Scale," "Patient Mobility Scale," and "Observer Mobility Scale." As a posttest, before the final mobilization of patients in the intervention and control groups before discharge, they will complete the "Patient Information Form," "State-Trait Anxiety Scale," and "Tampa Kinesiophobia Scale." Post-test data will be collected using the "Likert-Type Fear of Falling Scale," "Visual Analog Scale," and "Visual Analog Scale." Post-test data will be collected and recorded 5-10 minutes after mobilization is achieved using the "Visual Analog Scale," "Patient Mobility Scale," and "Observer Mobility Scale." Data will be collected face-to-face by the researchers. Ethics committee approval, Turkish Medicines and Medical Devices Agency (TİTCK), and institutional permissions have been obtained for the study. Patients will also provide informed consent in accordance with the Informed Consent Form. Statistical analyses will be performed using computer software using numbers, percentages, means, standard deviations, t-tests, and chi-square tests.

Вмешательства

  • Другое The group that will receive mobilization training using virtual reality glasses and brochures
    A group of 30 patients who will receive training on mobilization by watching videos and brochures using virtual reality glasses during the preoperative period (Intervention group).

Первичные конечные точки

  • Tampa Kinesiophobia Scale (TKS) [Срок оценки: eight months]
  • Patient Mobility Scale-HHO [Срок оценки: eight months]
Вторичные конечные точки (5)
  • Observer Mobility Scale-GHÖ [Срок оценки: eight months]
  • Visual Anolog Skala-VAS [Срок оценки: eight months]
  • State and Trait Anxiety Scale [Срок оценки: eight months]
  • Likert-Type Fear of Falling Scale [Срок оценки: eight months]
  • Patient Information Form [Срок оценки: eight months]

Критерии участия

İnclusion Criteria

  • The patient must be over 18 years of age
  • Participate in the study voluntarily,
  • Be undergoing lumbar surgery for the first time
  • Be undergoing lumbar stabilization surgery
  • Be oriented to person, place, and time
  • Not have taken any oral or parenteral analgesic medication other than the routine treatment ordered before mobilization
  • Have no restrictions (physical disability, etc.) that would prevent mobilization,
  • Be able to understand and speak Turkish
  • Have no vision or hearing problems,
  • Have no psychiatric illness, ağrı var
  • Be in ASA 1 or 2,
  • Patients planned to be included in the intervention and control groups must not be in the same rooms.

Критерии исключения

  • Having a neurological (such as dementia/Alzheimer's) or psychiatric (such as schizophrenia) medical diagnosis that affects cognitive status.
  • Having a chronic pain disorder.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Eskişehir Şehir Hastanesi — Eskişehir

Идентификаторы

NCT: NCT07231562 · SDU-Hemsire-OÖ-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗