High-Risk PregnancyNCT07724249
The Effect of a Virtual Reality Video Intervention
A study testing Virtual Reality Group in people with High-Risk Pregnancy and Anxiety, run by Sümeyye BAL at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of a virtual reality (VR) video intervention on fear of childbirth and anxiety among hospitalized high-risk pregnant women receiving bed rest. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- High-Risk Pregnancy, Anxiety
- What is being tested?
- Virtual Reality Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older
- Willing to participate in the study and provide written informed consent
- No diagnosed psychiatric or mental disorder
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Virtual Reality Headset-Based Video Intervention on Fear of Childbirth and Anxiety in High-Risk Pregnant Women
This randomized controlled trial aims to evaluate the effect of a virtual reality (VR) video intervention on fear of childbirth and anxiety among hospitalized high-risk pregnant women receiving bed rest. High-risk pregnancy and prolonged hospitalization may increase psychological distress, including fear of childbirth and anxiety. Virtual reality has emerged as a non-pharmacological distraction technique that promotes relaxation by immersing individuals in calming virtual environments. Participants in the intervention group will watch a nature-themed VR video with relaxing sounds using a VR headset in addition to routine care, while the control group will receive routine care only. The findings may provide evidence for the use of VR as a supportive nursing intervention to improve the psychological well-being of hospitalized high-risk pregnant women.
Read the detailed description
Pregnancy is a physiological process; however, approximately one-third of pregnancies are classified as high-risk due to maternal, fetal, or obstetric conditions that may threaten the health of the mother and/or fetus. Women with high-risk pregnancies frequently require hospitalization and bed rest for close maternal and fetal monitoring. Although hospitalization is essential for preventing adverse pregnancy outcomes, prolonged bed rest and uncertainty regarding pregnancy outcomes may increase psychological distress, particularly fear of childbirth and anxiety.
Fear of childbirth and anxiety are common among women with high-risk pregnancies and may negatively affect maternal well-being, treatment adherence, and pregnancy outcomes. Therefore, effective, safe, and non-pharmacological interventions that reduce psychological distress during hospitalization are needed.
Virtual reality (VR) is an immersive technology that provides users with a three-dimensional virtual environment and has been increasingly used as a distraction and relaxation intervention in healthcare settings. Previous studies have demonstrated that VR may reduce pain, anxiety, and stress in various clinical populations by diverting attention from unpleasant stimuli and promoting relaxation. However, evidence regarding the effectiveness of VR in reducing fear of childbirth and anxiety among hospitalized women with high-risk pregnancies is limited.
The present study is designed as a randomized controlled trial to evaluate the effectiveness of a VR-based relaxation intervention in hospitalized high-risk pregnant women receiving bed rest. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using block randomization.
Participants in the intervention group will receive routine obstetric and nursing care in addition to a VR intervention. During the intervention, participants will wear a compatible VR headset and watch a 360-degree nature-themed relaxation video accompanied by calming natural sounds for approximately 15 minutes while resting in bed. Participants in the control group will receive routine obstetric and nursing care only.
The primary outcomes of the study are fear of childbirth and anxiety. These outcomes will be measured using validated assessment instruments before and after the intervention. The effectiveness of the VR intervention will be determined by comparing outcome measures between the intervention and control groups.
This study is expected to provide evidence regarding the effectiveness of virtual reality as a safe, inexpensive, and non-pharmacological nursing intervention for reducing fear of childbirth and anxiety among hospitalized high-risk pregnant women. If effective, VR may be incorporated into routine prenatal inpatient care to improve maternal psychological well-being.
- Conditions
- High-Risk Pregnancy, Anxiety
- Being tested
- Virtual Reality Group
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GroupOther
Also called control
Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | In addition to routine obstetric and nursing care, participants assigned to the virtual reality group will receive a virtual reality intervention. Women in this group will wear a virtual reality headset while resting in bed and watch a relaxing 360° nature video accompanied by calming natural sounds for approximately 15 minutes. The virtual reality intervention is designed to promote relaxation and reduce fear of childbirth and anxiety during hospitalization. Receives: Other: Virtual Reality Group |
| control group | No intervention | Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety
State Anxiety Inventory (SAI) (State subscale of the State-Trait Anxiety Inventory, STAI-State)
Measured: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
Fear of Childbirth
Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)
Measured: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Jul 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk PregnancyStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sümeyye BAL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sümeyye BAL, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724249
- Sponsor's protocol ID
- 2023/44
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Virtual Reality Headset-Based Video Intervention on Fear of Childbirth and Anxiety in High-Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT07724249
- Acronym / sponsor ID
- 2023/44
- Conditions
- High-Risk Pregnancy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sümeyye BALUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 24 Jul 2026 (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 randomized controlled trial aims to evaluate the effect of a virtual reality (VR) video intervention on fear of childbirth and anxiety among hospitalized high-risk pregnant women receiving bed rest. High-risk pregnancy and prolonged hospitalization may increase psychological distress, including fear of childbirth and anxiety. Virtual reality has emerged as a non-pharmacological distraction technique that promotes relaxation by immersing individuals in calming virtual environments. Participants in the intervention group will watch a nature-themed VR video with relaxing sounds using a VR headset in addition to routine care, while the control group will receive routine care only. The findings may provide evidence for the use of VR as a supportive nursing intervention to improve the psychological well-being of hospitalized high-risk pregnant women.
Detailed description
Pregnancy is a physiological process; however, approximately one-third of pregnancies are classified as high-risk due to maternal, fetal, or obstetric conditions that may threaten the health of the mother and/or fetus. Women with high-risk pregnancies frequently require hospitalization and bed rest for close maternal and fetal monitoring. Although hospitalization is essential for preventing adverse pregnancy outcomes, prolonged bed rest and uncertainty regarding pregnancy outcomes may increase psychological distress, particularly fear of childbirth and anxiety.
Fear of childbirth and anxiety are common among women with high-risk pregnancies and may negatively affect maternal well-being, treatment adherence, and pregnancy outcomes. Therefore, effective, safe, and non-pharmacological interventions that reduce psychological distress during hospitalization are needed.
Virtual reality (VR) is an immersive technology that provides users with a three-dimensional virtual environment and has been increasingly used as a distraction and relaxation intervention in healthcare settings. Previous studies have demonstrated that VR may reduce pain, anxiety, and stress in various clinical populations by diverting attention from unpleasant stimuli and promoting relaxation. However, evidence regarding the effectiveness of VR in reducing fear of childbirth and anxiety among hospitalized women with high-risk pregnancies is limited.
The present study is designed as a randomized controlled trial to evaluate the effectiveness of a VR-based relaxation intervention in hospitalized high-risk pregnant women receiving bed rest. Eligible participants who provide written informed consent will be randomly assigned to either the intervention group or the control group using block randomization.
Participants in the intervention group will receive routine obstetric and nursing care in addition to a VR intervention. During the intervention, participants will wear a compatible VR headset and watch a 360-degree nature-themed relaxation video accompanied by calming natural sounds for approximately 15 minutes while resting in bed. Participants in the control group will receive routine obstetric and nursing care only.
The primary outcomes of the study are fear of childbirth and anxiety. These outcomes will be measured using validated assessment instruments before and after the intervention. The effectiveness of the VR intervention will be determined by comparing outcome measures between the intervention and control groups.
This study is expected to provide evidence regarding the effectiveness of virtual reality as a safe, inexpensive, and non-pharmacological nursing intervention for reducing fear of childbirth and anxiety among hospitalized high-risk pregnant women. If effective, VR may be incorporated into routine prenatal inpatient care to improve maternal psychological well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality GroupIn addition to routine obstetric and nursing care, participants assigned to the virtual reality group will receive a virtual reality intervention. Women in this group will wear a virtual reality headset while resting in bed and watch a relaxing 360° nature video accompanied by calming natural sounds for approximately 15 minutes. The virtual reality intervention is designed to promote relaxation and reduce fear of childbirth and anxiety during hospitalization. |
| control group | No intervention | –Participants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 18 years or older
- Willing to participate in the study and provide written informed consent
- No diagnosed psychiatric or mental disorder
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Virtual Reality GroupAlso: controlParticipants assigned to the control group will receive routine obstetric and nursing care only. No additional intervention will be administered. | Other | Virtual Reality Group |
Primary outcome
State Anxiety
Time frame: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
State Anxiety Inventory (SAI) (State subscale of the State-Trait Anxiety Inventory, STAI-State)
Fear of Childbirth
Time frame: Baseline (immediately before the intervention) and immediately after the 15-minute intervention
Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ Version A)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Group in people with High-Risk Pregnancy and Anxiety, run by Sümeyye BAL 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State Anxiety (time frame: Baseline (immediately before the intervention) and immediately after the 15-minute intervention). The study lists 2 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 Sep 2026.