Идёт набор NCT07085065

Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies

Без фазы С лечением Pain Management Anxiety Procedures Hematological Neoplasms

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: VR session.
Кому может быть актуально: Состояния в реестре: Pain Management, Anxiety, Procedures, Hematological Neoplasms. Базовые параметры: от 6 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: Tunisia
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial

Обзор

The goal of this clinical trial\] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question\[s\] it aims to answer are: Does VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session). External control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.

Подробное описание

This study is a prospective interventional crossover trial designed to evaluate the efficacy of Virtual Reality during painful procedures, including Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, and chemotherapy. Previous studies have suggested that virtual reality (VR) can distract patients from painful stimuli, enhance the quality of healthcare, and improve overall patient well-being.

Вмешательства

Устройство VR session
Standard care: Standard care. In both the external control group and the intervention group during Period 1, painful procedures will be performed ccording to usual clinical practice by trained healthcare professionals. VR session: The device includes a VR headset connected to a smartphone, which displays immersive visual content, along with headphones that deliver audio content. Scenarios are culturally and demographically adapted to the study population. The duration of each VR session will co

Первичные конечные точки

Change in pain levels using the Numeric Rating Scale (0-10) [Срок оценки: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure]

Вторичные конечные точки (1)

Change in Anxiety using the Spielberger State-Trait Anxiety Inventory (Y1 and Y2) [Срок оценки: Trait anxiety: Baseline State anxiety: Assessed within 5 minutes before the procedure and within 5 minutes after the procedure]

Критерии участия

Критерии включения

being ≥ 6 years old
having a confirmed diagnosis of a hematological malignancy
undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.