Идёт набор NCT07288047

Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion

Без фазы С лечением Abortion, First Trimester Pain Management Pain After Surgery Satisfaction

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 headset, Usual Care.
Кому может быть актуально: Состояния в реестре: Abortion, First Trimester, Pain Management, Pain After Surgery, Satisfaction. Базовые параметры: от 18 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: США
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 as an Adjunctive Agent for the Management of Pain and Anxiety During First Trimester Procedural Abortion: a Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.

Подробное описание

While procedural abortions are common outpatient procedures, providing optimal pain and anxiety relief during these procedures is challenging. With rapidly developing technological advances, virtual reality (VR) has emerged as a promising modality to help manage pain and anxiety control in the medical field, including obstetrics and gynecology. However, there are no studies evaluating the effect of VR on pain during a procedural abortion.

The goal of this randomized controlled trial is to primarily evaluate whether using a VR headset to display a meditative nature video as a noninvasive, low risk technology may reduce pain and anxiety for patients undergoing a first trimester procedural abortion in an outpatient setting. Investigators will also evaluate factors influencing satisfaction with the procedure. Investigators will compare use of the VR headset with usual care, to usual care only; for a first trimester procedural abortion, usual care includes oral pain medications, local anesthetic medication in the cervix, and verbal reassurance. Participants will be asked to complete a survey before, after, and one week following the procedure to assess pain, anxiety, and overall satisfaction.

Вмешательства

Устройство VR headset
VR Headset: Meta Quest 3S Meditative nature videos provided via "Guided Meditation VR" app.
Другое Usual Care
Usual care for pain and anxiety management during a first trimester procedural abortion includes oral ibuprofen, intracervical block, and verbal analgesia.

Первичные конечные точки

Pain scores during a first trimester procedural abortion [Срок оценки: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.]
Anxiety scores during a first trimester procedural abortion [Срок оценки: Day of enrollment: immediately preprocedure and 15 minutes postprocedure.]

Вторичные конечные точки (1)

Satisfaction with the first trimester procedural abortion [Срок оценки: Day of enrollment (immediately postprocedure) and one week after completion of the procedural abortion.]

Критерии участия

Критерии включения

Patients at Planned Parenthood of Western Pennsylvania who have decided to undergo and are eligible for a procedural abortion.
18 years old or older
<14 weeks gestation on day of abortion
Able to comprehend written English
Willing to comply with the study protocol
Willing and able to provide informed consent