PregnancyNausea and Vomiting in Pregnancy (NVP)Sleep QualityComfort
Investigational drug(s) / intervention(s)
Virtual Reality (VR) Visual Relaxation - Single SessionVirtual Reality (VR) Visual Relaxation - Three Sessions
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.
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.
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
49 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Overall Comfort Scale (GCQ) — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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