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

NCT07503080 | Enrolling By Invitation

• 1 other identifier: IstinyeU-SBE-FK-RK1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy; Nausea and Vomiting in Pregnancy (NVP); Sleep Quality; Comfort

Keywords

Virtual Reality Relaxation; Prenatal Care; Maternal Health

Outcome Measures

Primary Outcomes (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.

  Baseline and 24 hours after each session during the study period

Secondary Outcomes (2)

• 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

Study Arms (3)

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.

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

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.

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

Control Group

NO INTERVENTION

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

Interventions

Virtual Reality (VR) Visual Relaxation - Single Session BEHAVIORAL

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.

Also known as: VR Relaxation, Virtual Reality Relaxation, VR-based Visual Relaxation, Virtual Reality (VR)

Single-session VR Group

Virtual Reality (VR) Visual Relaxation - Three Sessions BEHAVIORAL

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.

Also known as: VR Relaxation, Virtual Reality Relaxation, VR-based Visual Relaxation

Three-session VR Group

Eligibility Criteria

• Age: 28 Years - 49 Years
• Gender Eligibility Details: Only biologically female individuals who are pregnant are eligible to participate in the study. Self-identified gender does not affect eligibility; participants must be pregnant women regardless of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Filiz Keskin: lead

Study Sites (1)

Istanbul Esenler Nenehatun Family Health Center

Istanbul, Esenler, 34220, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Nausea; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Refika Genc Koyucu, MD, PhD

  Istinye University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable due to the open-label design of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate, Specialist Nurse

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)