Pregnancy RelatedNCT05711875
The Effects of Using Virtual Reality Glasses During the Non-Stress Test
A study testing Virtual Reality (VR) glasses in people with Pregnancy Related, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Virtual Reality (VR) glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 1 Feb 2022
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- not carrying any risk factors (e.g., preeclampsia, intrauterine growth retardation (IUGR), premature rupture of membranes, gestational diabetes)
- having a singleton pregnancy and no vision problems
- No uterine contraction on the tracing paper at the end of NST
- having eaten at least two hours before NST
- not smoking or drinking alcoholic beverages at least two hours before NST
- having a systolic blood pressure value in the range of 90-140 mmHg and a diastolic blood pressure value in the range of 60-90 mm/Hg
- not having any problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation)
- having no communication barriers.
Who cannot join
- presence of fetal distress and emergency intervention planned by the physician
- uterine contraction as a result of NST
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Using Virtual Reality Glasses on Anxiety, Stress, and Fetal Well-Being During the Non-Stress Test
The aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.
Read the detailed description
Material and Method
This research was conducted between between October 2021 and February 2022 in Fethi Sekin City Hospital. When power analysis was performed, the sample size was calculated to be at least 71 women for each group (71 experiments, 71 controls). During the NST procedures, VR glasses were given to the participants in the experimental group by the researcher for the intervention. Data collection form for experimental and control groups before the NST procedures; Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) and State-Trait Anxiety Inventory (STAI) were applied two times before and after NST procedure. After the NST procedures, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.
- Conditions
- Pregnancy Related
- Being tested
- Virtual Reality (VR) glasses
- Keywords
- Anxiety, non-stress test, stress, virtual glasses
- 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 (VR) glassesOther
During the Non Stress Test (NST), the pregnant women in the experimental group watched a video of nature scenery with Virtual Reality (VR) glasses for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Glasses | Experimental | Virtual Reality (VR) glasses applied group Receives: Other: Virtual Reality (VR) glasses |
| Standard of care | No intervention | group without Virtual Reality (VR) glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scores
StateTrait Anxiety Scale (STAI The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
Measured: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Distress scores
Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version): The highest score from the scale is 34, the lowest score is 0. Higher scores indicate higher levels of perceived prenatal distress in the respondent
Measured: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Secondary outcomes (1)
Fetal Well-Being scores
NST Registration Form: In the interpretations, the baseline FHR was accepted as 110-160 bpm, variability in a reactive NST was accepted as an FHR of 6-25 bpm, and acceleration was accepted as an elevation in the baseline FHR by at least 15 bpm for at least 15 s. Additionally, deceleration was accepted as a 15-20 bpm drop in comparison to the baseline FHR, and a reactive NST was defined as a result where two or more accelerations peaked at least 15 bpm above the baseline point, each acceleration lasted 15 s or longer, and all these conditions were met within 20 min from the start of the test. A nonreactive NST was defined as the absence of at least two accelerations lasting at least 15 s on the NST tracing paper within 20 min from the start of the test
Measured: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start15 Oct 2021
- Primary completion21 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Crossover
- Model description
- This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevhibe Coban, Inonu University
- Investigators
- ESRA GÜNEY, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711875
- Sponsor's protocol ID
- 2021/2302
- Status last verified
- Jan 2023
- First submitted
- 26 Jan 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: research results will be shared.
Publications
Sridhar A, Shiliang Z, Woodson R, Kwan L. Non-pharmacological anxiety reduction with immersive virtual reality for first-trimester dilation and curettage: a pilot study. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):480-483. doi: 10.1080/13625187.2020.1836146.
PubMed 33140989
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Using Virtual Reality Glasses on Anxiety, Stress, and Fetal Well-Being During the Non-Stress Test
- ClinicalTrials.gov ID
- NCT05711875
- Acronym / sponsor ID
- 2021/2302
- Conditions
- Pregnancy Related
- Keywords
- Anxiety, non-stress test, stress, virtual glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 3 Feb 2023 (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 aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.
Detailed description
Material and Method
This research was conducted between between October 2021 and February 2022 in Fethi Sekin City Hospital. When power analysis was performed, the sample size was calculated to be at least 71 women for each group (71 experiments, 71 controls). During the NST procedures, VR glasses were given to the participants in the experimental group by the researcher for the intervention. Data collection form for experimental and control groups before the NST procedures; Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) and State-Trait Anxiety Inventory (STAI) were applied two times before and after NST procedure. After the NST procedures, both groups were re-administered. Descriptive statistics and independent t-test were used for data analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was designed as a randomized controlled trial conducted with experimental and control groups (71 experimental group, 71 control group).
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Glasses | Experimental | Other: Virtual Reality (VR) glassesVirtual Reality (VR) glasses applied group |
| Standard of care | No intervention | –group without Virtual Reality (VR) glasses |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- not carrying any risk factors (e.g., preeclampsia, intrauterine growth retardation (IUGR), premature rupture of membranes, gestational diabetes)
- having a singleton pregnancy and no vision problems
- No uterine contraction on the tracing paper at the end of NST
- having eaten at least two hours before NST
- not smoking or drinking alcoholic beverages at least two hours before NST
Key exclusion criteria (2 listed)
- presence of fetal distress and emergency intervention planned by the physician
- uterine contraction as a result of NST
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 (VR) glassesDuring the Non Stress Test (NST), the pregnant women in the experimental group watched a video of nature scenery with Virtual Reality (VR) glasses for 10 minutes | Other | Virtual Reality Glasses |
Primary outcome
Anxiety scores
Time frame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
StateTrait Anxiety Scale (STAI The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels
Distress scores
Time frame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version): The highest score from the scale is 34, the lowest score is 0. Higher scores indicate higher levels of perceived prenatal distress in the respondent
1 secondary outcome
Fetal Well-Being scores
Time frame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)
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 7 Sep 2023.
- Results publication: PubMed 33140989Sridhar A, Shiliang Z, Woodson R, Kwan L. Non-pharmacological anxiety reduction with immersive virtual reality for first-trimester dilation and curettage: a pilot study. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):480-483. doi: 10.1080/13625187.2020.1836146.
- Reference linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. research results will be shared.
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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.
ESRA GÜNEY principal investigator
Inonu 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 Virtual Reality (VR) glasses in people with Pregnancy Related, run by Inonu 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 8 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: finished, as of the sponsor's last update on 7 Sep 2023. 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?
Anxiety scores (time frame: NST involves 20 minutes of monitoring the fetal heart rate (FHR)). 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?
On the ClinicalTrials.gov record for NCT05711875, which also lists 1 linked publication.
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 7 Sep 2023.