Preventive Interventions for Chronic Pain Worsening
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: Virtual Reality-based Pain Self-management program.
- Кому может быть актуально
- Состояния в реестре: Chronic Non-Cancer Pain. 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
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This is an open label randomized controlled trial (RCT), which will be conducted with patients of the Copenhagen Wound Healing Center at Bispebjerg Hospital in Copenhagen (DK). The trial has two arms (1:1): A Virtual Reality based Pain Self-management (VRPS) program group, and a control group (usual care). Included will be 44 patients at least 18 years old; fluent in the Danish language; complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10); access to internet; and willing and available to participate in the study. Excluded will be specialized or multidisciplinary pain treatment at baseline; history of epilepsy, seizure disorder, nausea or dizziness, hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment; injury to eyes, face or neck.
Подробное описание
Considering the need of interventions to improve pain self-management to interrupt the "pain chronification" process and the indications regarding advantages of cognitive behavioral techniques and technologic resources, the purpose of this study is to test a homebased intervention connecting these areas. Here, the effects of a non-pharmacological technique delivered through a virtual reality-based pain self-management program will be tested in patients with non-cancer pain lasting three months or more. The intervention target primarily pain relief by providing pain regulating strategies.
The investigators will test the main hypothesis that participants assigned Virtual Reality-based Pain Self-management program (VRPS) present reduction of pain intensity among other outcomes at 2 months post-intervention as well as after 6-, 9-, and 12-months follow-up when compared to treatment as usual (control group).The primary aim is to investigate the effects of VRPS on worst pain intensity in the last 24h in patients with non-cancer pain lasting 3 months or more at 2 months post-intervention.The secondary aims are to analyze the effects of the intervention on other patient-reported outcomes measures (PROMs), which are pain intensity at follow-ups, pain interference in daily activities, pain catastrophizing, pain acceptance, health-related quality of life, anxiety, depression, perceived change on over-all pain status, use of analgesic medication, and use of health care system among patients with non-cancer pain lasting 3 months or more.
Вмешательства
- Устройство Virtual Reality-based Pain Self-management program
The VRPS has a variety of modules that can be used for pain management. For this project we have selected relaxation, mindful escapes, pain distraction games, and dynamic breathing modules. All modules were designed to minimize triggers of emotional distress or cybersickness.
Первичные конечные точки
- Pain intensity [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
Вторичные конечные точки (10)
- Pain intensity and interference in daily activities [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Pain catastrophizing [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Pain acceptance [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Health status [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Health related quality of life [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Anxiety [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Depression [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Use of medication [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Use of healthcare system [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
- Number of absent days at work [Срок оценки: At baseline, 2 months, 6 months, 9 months and 12 months after intervention]
Критерии участия
Критерии включения
- At least 18 years old
- Fluent in the Danish language
- Complaint of pain lasting 3 months or more; in average pain intensity score ≥ 3 (numerical rating scale 0 to 10)
- Access to internet
- Willing and available to participate in the study.
Критерии исключения
- Specialized or multidisciplinary pain treatment at baseline
- History of epilepsy
- Seizure disorder
- History of nausea or dizziness
- Hypersensitivity to flashing light or motion or other diseases that may prevent use of virtual reality equipment.
- Injury to eyes, face or neck that impedes comfortable use of virtual reality equipment.
- Current cancer disease
- Medical diagnosis of depression
- Cognitive dysfunction that interferers with compliance to the study,
- Currently pregnant or planning to become pregnant during the study period
- No access to the internet during the study period.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Факторный дизайн
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Дания · 1 центр
- Rigshospitalet — Copenhagen
Идентификаторы
NCT: NCT06351046 · NCT05178082_WP3