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临床试验/NCT07503080
NCT07503080Enrolling By Invitation不适用

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

Filiz Keskin1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
90
试验地点
1
主要终点
Overall Comfort Scale (GCQ)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Not applicable due to the open-label design of the study.

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Single-session VR Group

Experimental

Participants in this group will receive a single session of virtual reality (VR)-based visual relaxation. The intervention will last approximately 15 minutes and will be provided in addition to standard antenatal care.

干预措施: Virtual Reality (VR) Visual Relaxation - Single Session (Behavioral)

Three-session VR Group

Experimental

Participants in this group will receive three sessions of virtual reality (VR)-based visual relaxation, administered every other day. Each session will last approximately 15 minutes, in addition to standard antenatal care.

干预措施: Virtual Reality (VR) Visual Relaxation - Three Sessions (Behavioral)

Control Group

No Intervention

Pregnant women in this group will receive routine antenatal care without any additional intervention.

结局指标

主要结局

Overall Comfort Scale (GCQ)

时间窗: Baseline and 24 hours after each session during the study period

The scale can be administered using two different Likert types: a four-point scale and a six-point scale. Both forms have the same number of items, totaling 48 questions. In this research, the four-point Likert type was preferred for ease of use. The scale evaluates comfort levels in three dimensions: relief (16 items), relaxation (17 items), and coping with problems (15 items). Items consist of both positive and negative statements, the response order is mixed, and negative items are reverse-coded for scoring. A high score (4) on positive items indicates higher comfort, while a low score (1) indicates lower comfort. The highest possible total score on the scale is 192, and the lowest is 48. The total score is divided by the number of items to calculate the average value, and the result is evaluated between 1 and 4. Accordingly, low comfort is represented by one point, and high comfort by four points. The reliability coefficient of the scale was found to be 0.88 in the original study.

次要结局

  • Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Scale(Baseline and 24 hours after each session during the study period)
  • Richard Campbell Sleep Questionnaire (RCSQ) Scale(Baseline and 24 hours after each session during the study period)

研究者

发起方
Filiz Keskin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Filiz Keskin

PhD Candidate, Specialist Nurse

Istinye University

研究点 (1)

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