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PregnancyVRNCT07503080

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

A study testing Virtual Reality (VR) Visual Relaxation - Single Session and Virtual Reality (VR) Visual Relaxation - Three Sessions in people with Pregnancy and Nausea and Vomiting in Pregnancy (NVP), run by Filiz Keskin at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
What is being tested?
Virtual Reality (VR) Visual Relaxation - Single Session and Virtual Reality (VR) Visual Relaxation - Three Sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Mar 2026to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Istanbul Esenler Nenehatun Family Health Center

    Istanbul, Esenler, 34220

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Virtual Reality (VR) Visual Relaxation - Single Session, Virtual Reality (VR) Visual Relaxation - Three Sessions
Keywords
Virtual Reality Relaxation, Prenatal Care, Maternal Health
Medical subject headings
Nausea, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality (VR) Visual Relaxation - Single SessionBehavioural

    Also called VR Relaxation, Virtual Reality Relaxation, VR-based Visual Relaxation, Virtual Reality (VR)

    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 SessionsBehavioural

    Also called VR Relaxation, Virtual Reality Relaxation, VR-based Visual Relaxation

    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 groups in NCT07503080
Study groupRoleWhat they receive
Single-session VR GroupExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality (VR) Visual Relaxation - Single Session
Three-session VR GroupExperimentalParticipants 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.
Receives: Behavioral: Virtual Reality (VR) Visual Relaxation - Three Sessions
Control GroupNo interventionPregnant women in this group will receive routine antenatal care without any additional intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (2)
  1. 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.

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

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2026
  2. Study start23 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will be conducted as a parallel assignment randomized controlled trial with three arms. Participants will be randomly allocated into three groups: a single-session virtual reality (VR) intervention group, a three-session VR intervention group, and a control group receiving standard care. Each participant will remain in their assigned group throughout the study and will not cross over between groups. The interventions will be administered independently to each group, and outcomes will be compared between groups to evaluate the effectiveness of different VR intervention frequencies.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07503080
Sponsor's protocol ID
IstinyeU-SBE-FK-RK1
Acronym
VR
Status last verified
Mar 2026
First submitted
25 Mar 2026
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality (VR) Visual Relaxation - Single Session and Virtual Reality (VR) Visual Relaxation - Three Sessions in people with Pregnancy and Nausea and Vomiting in Pregnancy (NVP), run by Filiz Keskin at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Comfort Scale (GCQ) (time frame: Baseline and 24 hours after each session during the study period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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