Virtual Reality and Cryotherapy for Postoperative Pain and Anxiety After Cesarean Section (VRCSTrail)
Effectiveness of Virtual Reality and Cryotherapy on Postoperative Pain and Anxiety Among Women Undergoing Cesarean Section Under Spinal Anesthesia: A Three-Arm Factorial Randomized Controlled Trial
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Cesarean section is one of the most commonly performed surgical procedures worldwide. Despite advances in perioperative care, many women continue to experience moderate to severe postoperative pain and anxiety, which can negatively affect early mobilization, breastfeeding, maternal-infant bonding, and overall recovery. Although pharmacological analgesia remains the standard of care, non-pharmacological interventions may provide additional benefits while minimizing medication-related adverse effects.
Virtual reality is an immersive distraction technique that has shown promise in reducing pain perception and anxiety in various clinical settings. Cryotherapy is another non-pharmacological intervention that may reduce pain through local cooling, decreased nerve conduction velocity, and reduced inflammatory responses. However, evidence regarding their combined effectiveness after cesarean section remains limited.
The purpose of this randomized controlled trial is to evaluate the effectiveness of virtual reality and cryotherapy, individually and in combination, on postoperative pain and anxiety among women undergoing cesarean section under spinal anesthesia. Eligible participants will be randomly allocated to the study groups according to the trial protocol. Pain and anxiety outcomes will be measured using validated assessment instruments at predefined postoperative time points. The primary outcomes are postoperative pain intensity and anxiety. The results are expected to contribute to evidence-based postoperative nursing care by identifying effective, safe, and feasible non-pharmacological interventions for women undergoing cesarean section.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Female participants aged 18 to 45 years. Undergoing elective or emergency cesarean section under spinal anesthesia. Hemodynamically stable after surgery. Able to understand Arabic. Conscious, oriented, and able to complete study questionnaires. Willing to participate and provide written informed consent.
Exclusion Criteria:
Undergoing cesarean section under general anesthesia. Severe postoperative complications requiring intensive care. Severe visual or hearing impairment preventing virtual reality use. History of epilepsy or seizure disorder. Severe motion sickness or vestibular disorders. Known psychiatric illness interfering with outcome assessment. Cognitive impairment preventing completion of questionnaires. Skin disease, wound complications, cold hypersensitivity, Raynaud's phenomenon, or allergy/intolerance to cryotherapy.
Severe intraoperative or postoperative bleeding. Refusal to participate or withdrawal of informed consent.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Virtual Reality
Participants receive a 30-minute virtual reality intervention using a head-mounted display with calming audiovisual content in addition to routine postoperative care following cesarean section under spinal anesthesia.
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Participants receive a 30-minute immersive virtual reality session using a head-mounted display with calming, non-violent audiovisual content during the early postoperative period after cesarean section under spinal anesthesia.
The intervention is administered according to a standardized protocol.
Другие имена:
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Экспериментальный: Cryotherapy
Participants receive cryotherapy using cold gel packs (10-15°C) applied over or near the cesarean incision area for 15 minutes with a protective barrier, in addition to routine postoperative care.
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Participants receive localized cryotherapy using cold gel packs maintained at approximately 10-15°C and applied over or near the cesarean incision area for 15 minutes with a protective barrier between the cold pack and the skin.
Skin integrity is monitored before and after treatment.
Другие имена:
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Без вмешательства: Routine Care Control
Participants receive routine postoperative care according to the hospital protocol without virtual reality or cryotherapy during the study assessment period.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Postoperative Pain Intensity
Временное ограничение: Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
|
Postoperative pain intensity measured using the Visual Analogue Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain).
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Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Anxiety Score
Временное ограничение: Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
|
Anxiety measured using the Arabic version of the State-Trait Anxiety Inventory (STAI-State).
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Baseline (pre-intervention), immediately after the intervention, 2 hours after the intervention, and 6 hours after the intervention (if feasible).
|
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Time to First Rescue Analgesia
Временное ограничение: Up to 6 hours after the intervention.
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Time from completion of the intervention to the first administration of rescue analgesic medication.
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Up to 6 hours after the intervention.
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Total Analgesic Consumption
Временное ограничение: Up to 6 hours after the intervention.
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Total postoperative analgesic consumption during the observation period.
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Up to 6 hours after the intervention.
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Adverse Events
Временное ограничение: Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).
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Incidence of adverse events related to virtual reality or cryotherapy, including dizziness, nausea, headache, eye strain, motion sickness, excessive cold sensation, skin redness, numbness, burning sensation, or other treatment-related events.
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Throughout the intervention and postoperative observation period (up to 6 hours after the intervention).
|
Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
- Wang ZR, Ni GX. Is it time to put traditional cold therapy in rehabilitation of soft-tissue injuries out to pasture? World J Clin Cases. 2021 Jun 16;9(17):4116-4122. doi: 10.12998/wjcc.v9.i17.4116.
- Niyonkuru E, Iqbal MA, Zhang X, Ma P. Complementary Approaches to Postoperative Pain Management: A Review of Non-pharmacological Interventions. Pain Ther. 2025 Feb;14(1):121-144. doi: 10.1007/s40122-024-00688-1. Epub 2024 Dec 17.
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Боль
- Неврологические проявления
- Психические расстройства
- Послеоперационные осложнения
- Патологические процессы
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Боль, Послеоперационный
- Тревожные расстройства
- Терапия
- Оборудование и расходные материалы
- Электрическое оборудование и расходные материалы
- Носимые электронные устройства
- Криотерапия
- Умные очки
Другие идентификационные номера исследования
- S.B.M.U.26.858
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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