Virtual RealityVRPregAnxSlpNCT06996457
The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women
A study testing VR in people with Virtual Reality and Pregnancy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Virtual Reality, Pregnancy, Anxiety
- What is being tested?
- VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Dec 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having a diagnosed psychiatric disorder,
- Inability to speak Turkish.
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
Akdeniz Üniversitesi
Antalya, Konyalalt, 07070
About this study
Official title: The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women: Randomized Controlled Study
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.
- Conditions
- Virtual Reality, Pregnancy, Anxiety, Sleep Quality
- Being tested
- VR
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRDevice
The use of a virtual reality (VR) headset to present videos with nature imagery and natural sounds (music)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Virtual Reality Headset Group Receives: Device: VR |
| 2 | No intervention | No intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of trait anxiety levels in high-risk pregnant women.
An assessment will be conducted using the Trait Anxiety Inventory.
Measured: 5th day
Assessment of state anxiety levels in high-risk pregnant women
An assessment will be conducted using the State Anxiety Inventory.
Measured: 5th day
To determine the sleep quality of high-risk pregnant women.
An assessment will be conducted using the Pittsburgh Sleep Quality Index.
Measured: 5th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paralel özelliklere sahip iki Grup vardır. İlk grup sanal gerçeklik gözlükleri kullanan deneysel gruptur. İkinci grup ise herhangi bir müdahalede bulunulmayan kontrol grubudur.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feyzanur Gülçelik, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996457
- Sponsor's protocol ID
- Ethics Decision 13/7, 05.09.20
- Acronym
- VRPregAnxSlp
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Sleep Quality and Anxiety Level in High-risk Pregnant Women: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06996457
- Acronym / sponsor ID
- VRPregAnxSlp / Ethics Decision 13/7, 05.09.20
- Conditions
- Virtual Reality, Pregnancy, Anxiety, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paralel özelliklere sahip iki Grup vardır. İlk grup sanal gerçeklik gözlükleri kullanan deneysel gruptur. İkinci grup ise herhangi bir müdahalede bulunulmayan kontrol grubudur.
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: VRVirtual Reality Headset Group |
| 2 | No intervention | –No intervention will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Having a diagnosed psychiatric disorder,
- Inability to speak Turkish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRThe use of a virtual reality (VR) headset to present videos with nature imagery and natural sounds (music) | Device | 1 |
Primary outcome
Assessment of trait anxiety levels in high-risk pregnant women.
Time frame: 5th day
An assessment will be conducted using the Trait Anxiety Inventory.
Assessment of state anxiety levels in high-risk pregnant women
Time frame: 5th day
An assessment will be conducted using the State Anxiety Inventory.
To determine the sleep quality of high-risk pregnant women.
Time frame: 5th day
An assessment will be conducted using the Pittsburgh Sleep Quality Index.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR in people with Virtual Reality and Pregnancy, run by Akdeniz University 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 May 2025. 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?
Contact Feyzanur GÜLÇELİK, Specialist Nurse (+90 5389788986, feyzanurgulcelik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of trait anxiety levels in high-risk pregnant women. (time frame: 5th day). The study lists 3 primary outcomes in all. 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 30 May 2025.