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Not yet recruitingNCT06996457VRPregAnxSlpUpdated May 30, 2025

The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women

An interventional study of VR in Virtual Reality, Pregnancy and Anxiety, sponsored by Akdeniz University. Not yet recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Akdeniz University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study summary

This study aims to determine the effect of watching nature videos accompanied by natural sounds (music) through virtual reality (VR) headsets on sleep quality, state anxiety, and trait anxiety levels in high-risk pregnant women. The research is designed as a single-blind, randomized controlled experimental study. Data collection tools include the Pregnant Information Form, State-Trait Anxiety Inventory (STAI), and the Pittsburgh Sleep Quality Index (PSQI). The collected data will be analyzed using SPSS 25. Data collection is planned to take place between June 2025 and December 2026.

Read the detailed description

High-risk pregnancies are a process that carries complications that can negatively affect both maternal and fetal health, increasing stress and anxiety. In such pregnancies, women are more affected by both psychological and physiological changes. Increased stress and anxiety can threaten both the mother's and fetus's health and increase the likelihood of pregnancy complications. Additionally, common sleep problems during pregnancy, especially in the third trimester, become more pronounced and can negatively impact both physiological and psychological health. This project aims to investigate the effects of virtual reality headsets with nature scenes and sounds on sleep quality and anxiety levels in women with high-risk pregnancies. The virtual reality experience aims to reduce stress, improve sleep quality, decrease anxiety, and enhance overall physiological health for the women. Recently, virtual reality used in the medical field has helped reduce stress levels in pregnant women through nature imagery and sounds, promoting relaxation and improving sleep quality. With this technology, it may be possible to alleviate the psychological challenges encountered during pregnancy, thereby improving both maternal and fetal health. Therefore, researching the effects of virtual reality technology on psychological and physiological health in high-risk pregnancies is of great importance. The study will be conducted at the Perinatology Clinic of Health Sciences University Antalya Training and Research Hospital between June 2025 and December 2026 with 68 high-risk pregnant women. A randomized controlled design will be used, and participants will be divided into two groups. The intervention group will watch videos with nature scenes and sounds for 15 minutes each evening for 5 consecutive days, using virtual reality headsets. The control group will not receive any intervention. Data collection tools will include the Pregnancy Introduction Form, Anxiety Inventories, and the Pittsburgh Sleep Quality Index, and the data will be analyzed using SPSS 25. During the study, participants' psychological health, anxiety levels, and sleep quality will be regularly evaluated. This study aims to investigate the effects of virtual reality technology on psychological health in high-risk pregnancies and whether it reduces anxiety and improves sleep quality. The results may indicate that virtual reality helps cope with psychological challenges and improve fetal health. The study will contribute to the nursing literature by exploring the effects of virtual reality headsets on anxiety and sleep quality and will aim to develop suitable approaches for women with high-risk pregnancies. Additionally, virtual reality could be an effective non-pharmacological intervention. The results could bring innovations to health service policies and clinical practices, help healthcare workers develop more effective support strategies, and improve both maternal and fetal health.

02

Conditions studied

  • Virtual Reality
  • Pregnancy
  • Anxiety
  • Sleep Quality

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 68 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

Pregnant women who are hospitalized due to high-risk pregnancy and have been admitted for more than 3 days,

Able to communicate verbally,

Having no hearing or visual impairments,

Citizens of the Republic of Türkiye,

Willing to participate in the study.

Exclusion criteria

Exclusion Criteria:

Having a diagnosed psychiatric disorder,

Inability to speak Turkish.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    1

    Virtual Reality Headset Group

    Device: VR

  • No intervention
    2

    No intervention will be performed.

Interventions

  • DeviceVR

    The use of a virtual reality (VR) headset to present videos with nature imagery and natural sounds (music)

06

What researchers measure

Primary outcomes

  1. Assessment of trait anxiety levels in high-risk pregnant women.

    An assessment will be conducted using the Trait Anxiety Inventory.

    Time frame: 5th day

  2. Assessment of state anxiety levels in high-risk pregnant women

    An assessment will be conducted using the State Anxiety Inventory.

    Time frame: 5th day

  3. To determine the sleep quality of high-risk pregnant women.

    An assessment will be conducted using the Pittsburgh Sleep Quality Index.

    Time frame: 5th day

07

Study locations

1 site
  • Akdeniz Üniversitesi
    Antalya, Konyalalt 07070, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06996457
Lead sponsor
Akdeniz University
Responsible party
Feyzanur Gülçelik (Doctoral Student, Akdeniz University) — Principal investigator
First posted
May 30, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
May 30, 2025

Study contacts

Feyzanur GÜLÇELİK, Specialist Nurse
Contact
feyzanurgulcelik@gmail.com
+90 5389788986
Nurcan KIRCA, Doç. Dr.
Contact
nurcankirca@akdeniz.edu.tr
+90 5054168620

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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