Virtual Reality (VR) Based Relaxation for Nausea and Comfort in Pregnancy
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 (VR) Visual Relaxation - Single Session, Virtual Reality (VR) Visual Relaxation - Three Sessions.
- Кому может быть актуально
- Состояния в реестре: Pregnancy, Nausea and Vomiting in Pregnancy (NVP), Sleep Quality, Comfort. Базовые параметры: 18 лет — 49 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
- Turkey (Türkiye)
- 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 Effect of Virtual Reality-Based Visual Relaxation Application on Nausea and Vomiting Severity, Sleep Quality, and Pregnancy Comfort During Pregnancy: A Clinically Monitored Randomized Controlled Study
Обзор
This study aims to evaluate the effect of a virtual reality (VR)-based visual relaxation intervention on nausea and vomiting severity, sleep quality, and comfort in pregnant women. Nausea and vomiting are common symptoms during pregnancy and may negatively affect women's quality of life and overall well-being. Non-pharmacological interventions such as VR-based relaxation may provide a safe and effective alternative to improve these symptoms. In this randomized controlled study, pregnant women will be assigned to either an intervention group receiving VR-based relaxation or a control group receiving standard care. The outcomes will be assessed using validated measurement tools for nausea and vomiting severity, sleep quality, and comfort. The findings of this study are expected to contribute to improving maternal comfort and supporting non-invasive care approaches during pregnancy.
Подробное описание
Pregnancy is a period marked by significant physiological changes in a woman's body. Nausea and vomiting of pregnancy (NVP) are common experiences during this time, particularly in the first trimester, affecting a large proportion of pregnant women and often impairing quality of life. Symptoms typically emerge between the 4th and 7th weeks of gestation and usually subside by the 12th-14th weeks, although they may persist into later stages in some cases. While mild NVP is generally self-limiting, moderate to severe forms can result in fluid and electrolyte imbalances, malnutrition, decreased work capacity, and, in severe cases, hospitalization. Hyperemesis gravidarum, the most severe form of NVP, is relatively rare but can lead to significant maternal morbidity.
The impact of NVP extends beyond physical discomfort. It can increase stress, anxiety, and depressive symptoms, leading to considerable psychosocial distress. Limitations in daily activities, disruption of nutritional intake and sleep patterns, and reduced functional capacity further compromise overall pregnancy comfort.
Although pharmacological interventions such as vitamin B6, doxylamine, antihistamines, metoclopramide, and ondansetron are commonly used to manage NVP, some pregnant women may decline these treatments due to concerns regarding teratogenicity, potential effects on fetal development, or personal preferences. Consequently, there is a growing need for safe, non-pharmacological interventions that can effectively alleviate NVP symptoms.
Pregnancy comfort encompasses both physical and psychological dimensions of well-being. Physical comfort includes relief from pain, fatigue, dizziness, and gastrointestinal discomfort, whereas psychological comfort refers to reductions in anxiety, depressive symptoms, and pregnancy-related fears. Disturbances in either domain can significantly affect overall quality of life during pregnancy.
In recent years, digital health technologies have emerged as promising tools for supporting maternal health, particularly in out-of-hospital settings. Virtual Reality (VR) is one such technology that immerses users in a simulated sensory environment, providing distraction from symptoms and promoting relaxation. VR has been successfully applied in various clinical contexts, including pain management, anxiety reduction, labor relaxation, and control of nausea in chemotherapy patients. By redirecting attention away from discomfort, VR facilitates both psychological and physiological relaxation.
Studies investigating VR interventions often employ nature-themed visual content accompanied by soothing auditory stimuli, such as water or bird sounds. These interventions have been associated with reductions in stress hormone levels, improved heart rate and respiratory regulation, and activation of the parasympathetic nervous system. The resulting decreases in cortisol, increased subjective relaxation, and attenuation of stress-related gastrointestinal effects provide a plausible mechanistic basis for VR's effectiveness.
Research specifically examining VR's effects on NVP severity and pregnancy comfort is limited. Most existing evidence comes from chemotherapy or postoperative populations. Nevertheless, current literature suggests that VR is highly effective in promoting relaxation and reducing anxiety, indicating its potential utility in alleviating NVP symptoms during pregnancy.
The primary objective of this study is to evaluate the effects of a VR-based visual relaxation intervention on NVP severity, sleep quality, and overall pregnancy comfort. Participants will engage in daily sessions featuring nature-themed VR visual and musical content. The severity of nausea and vomiting will be assessed using the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) scale, sleep quality will be measured with the Richard-Campbell Sleep Questionnaire (RCSQ), and overall comfort will be evaluated using the General Comfort Scale.
This study introduces a novel, non-pharmacological, technology-based intervention for managing NVP. The accessibility, low cost, and ease of implementation of VR make it a promising approach for both individual and population-level maternal health support. Its non-invasive nature and absence of side effects render it suitable for use during pregnancy, potentially improving adherence and satisfaction. By addressing a gap in the literature, this research aims to strengthen the evidence base for VR interventions and support their integration into prenatal care guidelines.
Вмешательства
- Поведенческое Virtual Reality (VR) Visual Relaxation - Single Session
Participants will receive one session of virtual reality (VR)-based visual relaxation lasting approximately 15 minutes. The session will be administered in addition to standard antenatal care and is designed to promote relaxation, reduce nausea and vomiting severity, improve sleep quality, and enhance comfort during pregnancy. - Поведенческое Virtual Reality (VR) Visual Relaxation - Three Sessions
Participants will receive three sessions of virtual reality (VR)-based visual relaxation, each lasting approximately 15 minutes and administered every other day. The intervention will be provided in addition to standard antenatal care and is designed to promote relaxation, reduce nausea and vomiting severity, improve sleep quality, and enhance comfort during pregnancy.
Первичные конечные точки
- Overall Comfort Scale (GCQ) [Срок оценки: Baseline and 24 hours after each session during the study period]
Вторичные конечные точки (2)
- Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Scale [Срок оценки: Baseline and 24 hours after each session during the study period]
- Richard Campbell Sleep Questionnaire (RCSQ) Scale [Срок оценки: Baseline and 24 hours after each session during the study period]
Критерии участия
Критерии включения
- Women between 6 and 14 weeks of gestation
- Pregnancy-specific nausea and vomiting severity measured by PUQE-24 scale scoring 6-10 points
- No obstetric complications in the current pregnancy
- Aged 18-49 years
- Not using antiemetic medications
- Not using any pharmacological or non-pharmacological (alternative/complementary) interventions aimed at reducing nausea and vomiting
- Willing and able to provide informed consent for participation in the study
- Adequate Turkish language proficiency to read and understand study materials
Критерии исключения
- Diagnosis of hyperemesis gravidarum (HG).
- Presence of a diagnosed psychiatric disorder (e.g., depression, anxiety disorder).
- Presence of neurological, vestibular, or visual conditions that may prevent the use of a virtual reality headset (e.g., vertigo, epilepsy, migraine, visual impairments).
- Classified as a high-risk pregnancy (e.g., multiple pregnancy, history of diabetes, preeclampsia).
- Presence of cognitive or communication impairments that would hinder active participation in the study.
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
Turkey (Türkiye) · 1 центр
- Istanbul Esenler Nenehatun Family Health Center — Istanbul
Идентификаторы
NCT: NCT07503080 · IstinyeU-SBE-FK-RK1