Virtual Reality (VR) Based Relaxation for Nausea and Comfort in Pregnancy (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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Sleep Quality; Comfort; Nausea and Vomiting in Pregnancy (NVP)
• Intervention / Treatment: Behavioral: Virtual Reality (VR) Visual Relaxation - Single Session; Behavioral: Virtual Reality (VR) Visual Relaxation - Three Sessions

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Esenler
    • Istanbul, Esenler, Turkey (Türkiye), 34220
      • Istanbul Esenler Nenehatun Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single-session VR Group; 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.	Behavioral: 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.; Other Names: Virtual Reality (VR); VR Relaxation; Virtual Reality Relaxation; VR-based Visual Relaxation
Experimental: Three-session VR Group; 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.	Behavioral: 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.; Other Names: VR Relaxation; Virtual Reality Relaxation; VR-based Visual Relaxation
No Intervention: Control Group; Pregnant women in this group will receive routine antenatal care without any additional intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) Scale	The PUQE scale is designed to measure the severity of nausea and vomiting during pregnancy. It consists of three questions measuring the duration of nausea and the frequency of vomiting in the past 24 hours using a five-point Likert scale. Each question is scored between 1 and 5 points, with a total score of 3 to 15. A score of 3 indicates no nausea, 4-6 points mild, 7-12 points moderate, and ≥13 points severe nausea and vomiting.	Baseline and 24 hours after each session during the study period
Richard Campbell Sleep Questionnaire (RCSQ) Scale	The scale consists of 6 items that assess the depth of nighttime sleep, time to fall asleep, frequency of awakenings, duration of wakefulness upon waking, sleep quality, and ambient noise level. Each item is evaluated on a visual analog scale ranging from 0 to 100. A score of "0-25" indicates very poor sleep, while a score of "76-100" indicates very good sleep. The total score is evaluated based on 5 items; the 6th item, which assesses ambient noise level, is excluded from the total score evaluation. As the scale score increases, the patients' sleep quality also improves.	Baseline and 24 hours after each session during the study period

Collaborators and Investigators

• Sponsor: Filiz Keskin
• Investigators: Study Director: Refika Genc Koyucu, MD, PhD, Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Prenatal Care; Maternal Health; Virtual Reality Relaxation
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Signs and Symptoms, Digestive; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Nausea
• Other Study ID Numbers: IstinyeU-SBE-FK-RK1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No