Fetal Health AnxietyNCT07660393
The Use of Virtual Reality Glasses in Women With Premature Rupture of Membranes
A study testing Standard prenatal care and Nature-themed video in people with Fetal Health Anxiety and Prenatal Distress, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women with Premature Rupture of Membranes: A Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Health Anxiety, Prenatal Distress, Prenatal Attachment
- What is being tested?
- Standard prenatal care and Nature-themed video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2026to 1 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 years of age or older
- Being nulliparous
- Having a diagnosis of preterm premature rupture of membranes (PPROM)
- Being between 24 and 37 weeks of gestation
- Having a singleton pregnancy
- Being hospitalized in the ward for at least 3 days
Show all 9Show fewer
- Having no visual or hearing impairment
- Being communicative and mentally and psychologically healthy
- Being able to speak and express oneself in Turkish
Who cannot join
- Having an additional diagnosis besides preterm premature rupture of membranes (PPROM) (e.g., preeclampsia, fetal distress, fetal anomalies, gestational diabetes, bleeding, etc.)
- Having a chronic disease (e.g., hypertension, diabetes mellitus, thyroid disorders, etc.)
- Having conceived through assisted reproductive technologies (ART)
- Having any skin infection.
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, 1 recruiting
- Recruiting
Seyhan Çankaya
Konya, 42250
Seyhan Çankaya, PhD, 05054300733, seyhane32@gmail.com
Seyhan Çankaya, PhD
About this study
Official title: The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women With Premature Rupture of Membranes: A Randomized Controlled Trial
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women with Premature Rupture of Membranes: A Randomized Controlled Trial
Read the detailed description
This study is a randomized controlled trial. The study population will consist of nulliparous pregnant women hospitalized with a diagnosis of preterm premature rupture of membranes (PPROM) in the Perinatology Clinic of Konya City Hospital between June 2025 and January 2027. A total of 176 pregnant women who will be giving birth for the first time will be included in the study (intervention group: n = 88; control group: n = 88). In the intervention group, pregnant women with PPROM will watch a nature-themed video accompanied by natural sounds selected by the researchers through a virtual reality headset (VRH) twice daily for three consecutive days, with each session lasting at least five minutes. The control group will receive the standard antenatal care provided by the hospital. Data will be collected using a Personal Information Form, the Fetal Health Anxiety Scale, the Prenatal Distress Questionnaire, and the Prenatal Attachment Inventory.
- Conditions
- Fetal Health Anxiety, Prenatal Distress, Prenatal Attachment
- Being tested
- Standard prenatal care, Nature-themed video
- Keywords
- Virtual Reality Glasses (VRG), Fetal Health Anxiety, Prenatal Distress Scale, Prenatal Attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard prenatal careOther
The control group will receive standard prenatal care and treatment provided by the hospital.
After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish.
Nature-themed videoOther
Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days.
| Study group | Role | What they receive |
|---|---|---|
| Standard prenatal care | Placebo comparator | The control group will receive standard prenatal care and treatment provided by the hospital.
After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish. Receives: Other: Standard prenatal care; Other: Nature-themed video |
| Nature-themed video | Experimental | Pregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days. Receives: Other: Nature-themed video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.
Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.
Measured: 6 months
Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.
The Fetal Health Concern Scale will be administered to pregnant women.
The Fetal Health Concern Scale ranges from 0 to 42 points (minimum-maximum), with higher scores indicating greater fetal health concern.
Measured: 6 months
Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
The Prenatal Distress Scale will be administered to all pregnant women.
The Prenatal Distress Scale ranges from 0 to 34 points (minimum-maximum), with higher scores indicating greater prenatal distress.
Measured: 6 months
Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.
The Prenatal Attachment Inventory will be administered to all pregnant women.
The Prenatal Attachment Inventory score ranges from 21 to 84 points (minimum-maximum), with higher scores indicating greater prenatal distress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start16 Jun 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Health AnxietyStudies of the same condition, open and under way.
- More trials run by Selcuk 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyhan Çankaya, Selcuk University
- Investigators
- Seyhan Çankaya, Phd, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660393
- Sponsor's protocol ID
- 2025/1150
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women With Premature Rupture of Membranes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07660393
- Acronym / sponsor ID
- 2025/1150
- Conditions
- Fetal Health Anxiety, Prenatal Distress, Prenatal Attachment
- Keywords
- Virtual Reality Glasses (VRG), Fetal Health Anxiety, Prenatal Distress Scale, Prenatal Attachment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 22 Jun 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.
The Effect of Virtual Reality Glass Use on Fetal Health Anxiety, Prenatal Distress, and Maternal-Fetal Attachment in Women with Premature Rupture of Membranes: A Randomized Controlled Trial
Detailed description
This study is a randomized controlled trial. The study population will consist of nulliparous pregnant women hospitalized with a diagnosis of preterm premature rupture of membranes (PPROM) in the Perinatology Clinic of Konya City Hospital between June 2025 and January 2027. A total of 176 pregnant women who will be giving birth for the first time will be included in the study (intervention group: n = 88; control group: n = 88). In the intervention group, pregnant women with PPROM will watch a nature-themed video accompanied by natural sounds selected by the researchers through a virtual reality headset (VRH) twice daily for three consecutive days, with each session lasting at least five minutes. The control group will receive the standard antenatal care provided by the hospital. Data will be collected using a Personal Information Form, the Fetal Health Anxiety Scale, the Prenatal Distress Questionnaire, and the Prenatal Attachment Inventory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard prenatal care | Placebo comparator | Other: Standard prenatal care, Other: Nature-themed videoThe control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish. |
| Nature-themed video | Experimental | Other: Nature-themed videoPregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Being 18 years of age or older
- Being nulliparous
- Having a diagnosis of preterm premature rupture of membranes (PPROM)
- Being between 24 and 37 weeks of gestation
- Having a singleton pregnancy
Key exclusion criteria (4 listed)
- Having an additional diagnosis besides preterm premature rupture of membranes (PPROM) (e.g., preeclampsia, fetal distress, fetal anomalies, gestational diabetes, bleeding, etc.)
- Having a chronic disease (e.g., hypertension, diabetes mellitus, thyroid disorders, etc.)
- Having conceived through assisted reproductive technologies (ART)
- Having any skin infection.
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 |
|---|---|---|
| Standard prenatal careThe control group will receive standard prenatal care and treatment provided by the hospital. After the study is completed, control group participants will be shown nature-themed videos via Virtual Reality Glasses (VRG) if they wish. | Other | Standard prenatal care |
| Nature-themed videoPregnant women with premise rupture of membranes (PRM) in the intervention group will be shown a nature-themed video prepared by the researchers with nature sounds via Virtual Reality Glasses (VRG) twice a day for at least five minutes each time for three days. | Other | Nature-themed video, Standard prenatal care |
Primary outcome
Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires.
Time frame: 6 months
Sociodemographic information of pregnant women will be collected, compared, and reported through questionnaires.
Comparison of mean scores on the Fetal Health Concern Scale among groups of pregnant women.
Time frame: 6 months
The Fetal Health Concern Scale will be administered to pregnant women. The Fetal Health Concern Scale ranges from 0 to 42 points (minimum-maximum), with higher scores indicating greater fetal health concern.
Comparison of mean Prenatal Distress Scale scores among groups of pregnant women.
Time frame: 6 months
The Prenatal Distress Scale will be administered to all pregnant women. The Prenatal Distress Scale ranges from 0 to 34 points (minimum-maximum), with higher scores indicating greater prenatal distress.
Comparison of mean Prenatal Attachment Inventory scores among groups of pregnant women.
Time frame: 6 months
The Prenatal Attachment Inventory will be administered to all pregnant women. The Prenatal Attachment Inventory score ranges from 21 to 84 points (minimum-maximum), with higher scores indicating greater prenatal distress.
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 11 Aug 2026.
- 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.
Seyhan Çankaya, Phd study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard prenatal care and Nature-themed video in people with Fetal Health Anxiety and Prenatal Distress, run by Selcuk 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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Aug 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. Some participants in this study may receive a placebo. 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 Seyhan Çankaya, PhD (+905054300733, seyhane32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sociodemographic characteristics of pregnant women with premature rupture of membranes prior to intervention using questionnaires. (time frame: 6 months). The study lists 4 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 11 Aug 2026.