VR
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
Sponsor study identifier
interventional
90
1 country
1
Study Start
March 23, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2026
Actual (reported)March 25, 2026
Actual (reported)March 31, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall Comfort Scale (GCQ)
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.
Baseline and 24 hours after each session during the study period
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Scale
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.
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.
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.
Istanbul Esenler Nenehatun Family Health Center
Istanbul, Esenler, 34220, Turkey (Türkiye)
Refika Genc Koyucu, MD, PhD
Istinye University
First Submitted
March 25, 2026
First Posted
March 31, 2026
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
Pregnant women in this group will receive routine antenatal care without any additional intervention.
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.
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Study Start
March 23, 2026
Actual (reported)Primary Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 6, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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