Virtual Reality Intervention to Reduce Pain in Women Undergoing Elective Oocyte Cryopreservation
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 relaxation intervention, Standard Care Control.
- Кому может быть актуально
- Состояния в реестре: Procedure-Related Pain, Acute Pain. Базовые параметры: 18 лет — 45 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Израиль
- 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
The Effectiveness of Virtual Reality for Pain Reduction in Women Undergoing Elective Oocyte Cryopreservation: A Randomized Controlled Trial
Обзор
This randomized controlled study evaluates whether exposure to relaxing virtual reality (VR) scenery prior to oocyte retrieval can reduce pain in women undergoing elective oocyte cryopreservation. Many women experience discomfort before and after oocyte retrieval. Virtual reality has been shown to reduce pain in various medical settings by providing distraction and relaxation. In this study, participants are randomly assigned to receive either routine care alone or routine care combined with a VR-based relaxation intervention while waiting for the procedure. Pain is assessed using validated questionnaires and standardized scales before and after oocyte retrieval. The results of this study may help determine whether VR can serve as a simple, safe, and non-pharmacological method to improve patient comfort during elective egg freezing.
Подробное описание
This study is a prospective, randomized controlled clinical trial evaluating the effectiveness of virtual reality (VR) in reducing pain among women undergoing elective oocyte cryopreservation.
Eligible participants awaiting oocyte retrieval are recruited at the fertility unit. All participants receive detailed information about the study and provide written informed consent prior to enrollment.
Participants are randomized into two parallel groups. The intervention group receives routine care in addition to exposure to relaxing virtual reality nature scenery using a VR headset for approximately 20 minutes prior to oocyte retrieval. The control group receives routine care without exposure to virtual reality.
Baseline assessments include demographic data, medical history, pain sensitivity questionnaire (PSQ), baseline visual analog scale (VAS) pain score, pain threshold assessment, and vital signs.
Following the procedure, pain is reassessed using the visual analog scale. Analgesic administration is documented from medical records. Additional post-procedure assessments include pain-related parameters and vital signs.
The primary outcome is post-procedure pain intensity measured using the VAS. Secondary outcomes include pain sensitivity measures, analgesic consumption, and physiological parameters.
All collected data include demographic variables, clinical parameters, baseline and post-procedure pain scores, pain-related measures, vital signs, and medication use. Data are coded and stored in a secure institutional database.
Statistical analysis compares outcomes between groups using appropriate parametric or non-parametric methods according to data distribution.
This study aims to assess whether pre-procedure virtual reality exposure can serve as a safe and effective non-pharmacological adjunct for pain reduction in women undergoing elective oocyte cryopreservation.
Вмешательства
- Поведенческое Virtual reality relaxation intervention
Participants are exposed to relaxing virtual reality nature scenery videos using a VR headset for approximately 20 minutes prior to oocyte retrieval, in addition to routine care. - Поведенческое Standard Care Control
Participants receive routine care prior to oocyte retrieval without exposure to virtual reality.
Первичные конечные точки
- Post-procedure pain intensity [Срок оценки: Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval)]
Вторичные конечные точки (7)
- Baseline pain sensitivity [Срок оценки: Before oocyte retrieval]
- Heart rate during oocyte retrieval [Срок оценки: Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure]
- Pain intensity prior to discharge [Срок оценки: Prior to discharge (same day as oocyte retrieval)]
- Change in pain intensity from pre-procedure to post-procedure [Срок оценки: From pre-procedure (at admission) to immediately post-procedure in the recovery room]
- Post-procedure analgesic consumption [Срок оценки: From completion of oocyte retrieval until discharge from the recovery unit]
- Systolic blood pressure during oocyte retrieval [Срок оценки: Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure]
- Diastolic blood pressure during oocyte retrieval [Срок оценки: Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure]
Критерии участия
Критерии включения
- Women undergoing elective oocyte retrieval for fertility preservation.
- Age 18-45 years.
- Ability to provide informed consent.
Критерии исключения
- Use of pain relief, anti-anxiety, or antidepressant medications prior to the intervention.
- Any condition for which VR use is not recommended, including:
- History of seizures
- Sensitivity to flashing light or motion
- Migraine headaches
- Predisposition to nausea or dizziness (e.g., vertigo)
- Any injury to the eyes, face, or neck limiting use of the VR device, including blindness.
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
- Лечение
Центры проведения
Израиль · 1 центр
- Hadassah Medical Organization — Jerusalem
Идентификаторы
NCT: NCT07484815 · 0497-23-HMO-CTIL