Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy

Официальное название

Comparison of Virtual Reality and Podcast in Improving Patient Experience During Colposcopy: A Randomized Controlled Trial

Обзор

This study wants to see if two things-virtual reality (VR) and podcasts-can help women feel better during a medical test called colposcopy. The study looks at stress, anxiety, pain, and heartbeat. It also checks if women are happy with the test and how long the test takes. There are three groups: one uses VR, one listens to a podcast, and one gets no extra help. The study will include 75 women in Turkey. All women are 25 to 65 years old and need to have a colposcopy. Some women cannot join the study-for example, if they are pregnant, cannot see or hear well, or take strong medicine for pain or stress.

Вмешательства

• Другое VR
  Participants will view a relaxing virtual environment (e.g. nature landscapes, lightly animated themes) for 5 minutes prior to the colposcopy procedure and during the colposcopy wearing a VR headset.
• Другое Podcast
  Participants will listen to a podcast of relaxing or informative content for 5 minutes before and 5 minutes during colposcopy. The content will be selected according to individual preferences (e.g. storytelling, humorous content or educational content).

Первичные конечные точки

• Perceived Stress Scale [Срок оценки: Before and after colposcopy at 5 min.]
• State Anxiety Inventory [Срок оценки: Before and after colposcopy procedure 5 min.]
• Visual Analog Scale [Срок оценки: Before and after colposcopy procedure 5 min.]

Вторичные конечные точки (3)

• Patient Satisfaction Scale [Срок оценки: 5 minutes after colposcopy procedure]
• Pulse measurement [Срок оценки: 5 minutes before and after the colposcopy procedure.]
• Prosedur duration [Срок оценки: During the colposcopy procedure (in minutes)]

Критерии участия

Критерии включения

• Patients scheduled for colposcopy procedure due to suspicion of cervical squamous intraepithelial lesions.
• Individuals who agree to sign the informed consent form and are willing to participate after being informed about the procedure.
• Individuals who are deemed suitable for the colposcopy procedure and whose health status does not constitute an obstacle to perform this procedure (no visual or hearing impairment).
• Volunteers who speak Turkish at a level to understand the methods and questionnaires used in the study.

Критерии исключения

• Those with claustrophobia, epilepsy, or any other neurological or psychological disorder that may cause discomfort when using the VR headset.
• Individuals with hearing loss that affects their ability to hear podcast content.
• Individuals with vision loss that affects their ability to see VR content.
• Individuals who have previously experienced discomfort while using VR or are unable to adapt to VR
• Individuals who are not suitable for the colposcopy procedure or have a serious health condition that may affect the procedure
• Individuals who are pregnant.
• Individuals with language barriers who may have difficulty understanding the study procedures or distractions.
• Individuals with regular use of sedative or pain medication that may affect stress or pain management during the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Etlik City Hospital,Department of Gynecology Oncology — Ankara

Идентификаторы

NCT: NCT06940583 · VR24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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