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Набор скоро начнётся NCT07512999

The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test

Без фазы С лечением Pregnancy - Prenatal Testing

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, Nature sounds, Control.
Кому может быть актуально
Состояния в реестре: Pregnancy - Prenatal Testing. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test on Fetal Well-Being, Maternal Anxiety, Comfort, and Satisfaction

Обзор

The aim of this study is to examine the effect of using nature sounds and virtual reality during the non-stress test on fetal well-being, maternal anxiety, comfort, and satisfaction. The study sample will consist of all pregnant women admitted to the Non-Stress Test (NST) unit. A total of 150 women will be included in the sample: 50 for the virtual reality group, 50 for the nature sounds group, and 50 for the control group.

Подробное описание

Pregnancy is a multidimensional process characterized not only by physiological changes but also by the restructuring of social roles and psychological adaptation. The changes that occur during this process affect both the mother and the fetus. Increased maternal stress and anxiety may influence fetal development through hormonal mechanisms. Therefore, regular and holistic monitoring of pregnancy is important. Antenatal care is a systematic evaluation process aimed at protecting maternal and fetal health and identifying risk factors. One of the frequently used non-invasive methods for assessing fetal health is the non-stress test. It is widely used because it is easy to administer and considered safe. The test evaluates the relationship between fetal heart rate, fetal movements, and uterine contractions. A reactive result indicates that the fetus is in good condition, whereas a non-reactive result may require further evaluation. Although the non-stress test is non-invasive and painless, it generally lasts at least 20 minutes, and remaining in the same position may lead to hypotension, discomfort, and anxiety. Increased maternal anxiety may affect fetal heart rate patterns, increase false-positive rates, and result in unnecessary interventions. Therefore, non-pharmacological interventions aimed at increasing maternal comfort and reducing anxiety during the NST process are important. Nature sounds may reduce perceived stress by promoting relaxation, while virtual reality may decrease anxiety and increase satisfaction by diverting attention away from the environment. The aim of this study is to determine the effects of using nature sounds and virtual reality during the non-stress test on fetal well-being, maternal anxiety, comfort, and satisfaction. The study sample will consist of all pregnant women admitted to the Non-Stress Test (NST) unit. A total of 150 women will be included in the sample: 50 for the virtual reality group, 50 for the nature sounds group, and 50 for the control group. Personal Information Form, Non Stress Test Evaluation Form, Visual Analog Scale for Satisfaction (VAS-Satisfaction), Visual Analog Scale for Comfort (VAS-Comfort), Spielberger State-Trait Anxiety Inventory (STAI) Scale, Intervention for the experimental group, the Evaluation Form (Virtual reality, Nature sounds) will be used in data collection.

Вмешательства

  • Поведенческое Virtual Reality
    Women treated with virtual reality will be presented with videos of natural scenes (forest and sea) accompanied by nature sounds and asked to watch. The headset will be fitted before the procedure begins, and women will be instructed on how to continue watching the video while wearing the headset during the procedure.
  • Поведенческое Nature sounds
    Women in the nature sounds group will be given the opportunity to listen to relaxing nature sounds (sea, rain, wind, river, birds) using MP3 players and headphones according to their preferences throughout the non-stress test.
  • Поведенческое Control
    Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention will perform.

Первичные конечные точки

  • State-Trait Anxiety Inventory (STAI) Scale [Срок оценки: Before the non-stress test and after the procedure is completed (20 minutes after the start of the procedure)]
  • Visual Analog Scale for Comfort (VAS-Comfort) [Срок оценки: After the non-stress test is completed (20 minutes after the start of the procedure)]
  • Visual Analog Scale for Satisfaction (VAS-Satisfaction) [Срок оценки: After the non-stress test is completed (20 minutes after the start of the procedure)]
  • Non Stress Test Evaluation Form [Срок оценки: After the non-stress test is completed (20 minutes after the start of the procedure)]
  • Intervention for the experimental group The Evaluation Form (Virtual reality, Nature sounds) [Срок оценки: After the non-stress test is completed (20 minutes after the start of the procedure)]

Критерии участия

Критерии включения

  • Being 18 years of age or older
  • Being at 32 weeks of gestation or beyond
  • Having a healthy pregnancy
  • Having a singleton and viable pregnancy
  • Not using tobacco or alcohol
  • Having eaten at least two hours before the NST procedure

Критерии исключения

  • Having any communication impairment (language, vision, hearing, speech, etc.)
  • Having a physical or cognitive condition that prevents the use of the virtual reality application and nature sound Having a diagnosis of a high-risk pregnancy Having a diagnosis of a significant chronic (cardiac, renal, neurological, etc.) or psychiatric disorder (psychosis, neurosis, substance dependence, etc.) Having a multiple pregnancy Having a fetus with an anomaly Experiencing fetal distress requiring emergency intervention Having uterine contractions

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.

Идентификаторы

NCT: NCT07512999 · S-Tez

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗