Effectiveness of a Virtual Reality Intervention on Pain, Anxiety, and Satisfaction in Laboring Women

Обзор

This study is designed to evaluate whether a virtual reality (VR) intervention can help reduce pain and anxiety and improve childbirth satisfaction among laboring women. Eligible participants will be randomly assigned to either a VR intervention group or a control group receiving standard intrapartum care. Women in the VR group will use a virtual reality headset that provides immersive natural imagery and music during labor, while women in the control group will receive routine care without VR. The study will compare levels of labor pain, anxiety, and childbirth satisfaction between the two groups to determine the effectiveness of the virtual reality intervention as supportive care during labor.

Подробное описание

This randomized, parallel-group interventional study aims to evaluate the effectiveness of a virtual reality (VR) intervention as supportive care during labor. The study will be conducted among laboring women admitted for childbirth who meet the eligibility criteria.

Eligible participants will be randomly assigned to one of two groups: a virtual reality intervention group or a control group receiving standard intrapartum care without additional intervention. Randomization will be performed using an appropriate allocation method to ensure comparable groups. Due to the nature of the intervention, this study will be conducted as an open-label trial.

Participants assigned to the VR intervention group will receive virtual reality-based supportive care during labor. The intervention involves the use of a head-mounted VR device providing immersive natural imagery and calming music, intended to promote relaxation and distraction from labor-related discomfort. The VR intervention will be administered during the active phase of labor according to the study protocol.

Participants in the control group will receive routine intrapartum care in accordance with standard clinical practice, without exposure to virtual reality or other additional supportive interventions beyond usual care.

The primary outcome of the study is labor pain intensity, assessed using the Visual Analogue Scale (VAS) during the active phase of labor. Secondary outcomes include maternal anxiety during labor, measured using the State subscale of the State-Trait Anxiety Inventory (STAI-S), and childbirth satisfaction, assessed using the Childbirth Experience Questionnaire (CEQ) within 48 hours postpartum.

Outcome measures will be compared between the intervention and control groups to determine the effectiveness of the virtual reality intervention in reducing labor pain and anxiety and improving childbirth satisfaction.

Вмешательства

• Диагностический тест Virtual Reality
  Virtual reality interventions offer a promising avenue for addressing the challenges faced by laboring women in Taiwan, particularly in the context of nursing shortages. By effectively reducing pain, anxiety, and improving childbirth satisfaction, these interventions present a cost-effective and easily implementable solution with multiple benefits.

Первичные конечные точки

• Labor pain intensity as measured by the Visual Analogue Scale (VAS) [Срок оценки: During the active phase of labor]

Вторичные конечные точки (2)

• Maternal anxiety during labor as measured by the State-Trait Anxiety Inventory (STAI-S) [Срок оценки: At baseline (admission for labor) and immediately after the intervention]
• Childbirth satisfaction as measured by the Childbirth Experience Questionnaire (CEQ) [Срок оценки: Within 48 hours postpartum]

Критерии участия

Women meeting the following criteria were eligible for enrollment:

• Pregnant.
• Aged 18 years or older.
• Pregnant for more than 37 weeks.
• Single baby born in the cephalic presentation and willing to deliver naturally.
• Admitted to the hospital during the latent period.
• No major medical conditions or complications during pregnancy for either mother or baby.
• Able to hear, speak, read, and write Chinese.
• Interested in participating in this study and agreeing to complete the questionnaire.

Women meeting the above criteria will be enrolled after the researchers explain the research methods and objectives. Exclusion criteria include:

• Virtual reality sickness.
• Vision or hearing problems.
• Withdrawal from the study.
• Maternal or fetal condition requiring emergency cesarean section.
• Those diagnosed with migraine, epilepsy, or mental illness.

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

Список центров уточняется — проверьте первичный протокол.

Публикации

• Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973. PMID 30702436

Идентификаторы

NCT: NCT07329764 · TYGH114028

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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