Virtual RealityVirtualNCT05093283
The Effect of Virtual Reality Glasses on Fetal Movement
A study testing Virtual Reality Glasses in people with Virtual Reality, run by Mine Gokduman Keles at 1 site in Turkey (Türkiye).
Trial summary
When the literature is examined, it is seen that virtual reality glasses are used during medical procedures, have an anxiety-lowering effect and have a reducing effect on the perception of fatigue (20, 7, 10, 11). Read more about this study
- Who is it for?
- Ages 32 to 40 weeks, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- Virtual Reality Glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Jun 2021
- 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 32 to 40 weeks
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Between the ages of 18-45,
- Healthy pregnant women,
- No cardiovascular disease diagnosed in the fetus,
- Having completed the 32nd gestational week,
- Having eaten at least two hours before the NST procedure,
- Not smoking or consuming alcohol at least two hours before the NST procedure,
- Pregnant women who have no communication and visual impairments were included in the study.
Who cannot join
- • Pregnant women with fetal distress and for whom emergency intervention is considered by the physician,
- Pregnant women with impaired NST and needing intervention at that time,
- Pregnant women with uterine contraction as a result of NST were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
TurkishMoHKahramanmarasPH
Kahramanmaraş, Onikişubat
About this study
Official title: The Effect of Virtual Reality Glasses on Fetal Movement, Fetal Heart Rate, Maternal Satisfaction and Anxiety Level
When the literature is examined, it is seen that virtual reality glasses are used during medical procedures, have an anxiety-lowering effect and have a reducing effect on the perception of fatigue (20, 7, 10, 11). On the other hand, no study has been found in the literature on the application of virtual glasses to pregnant women who underwent NST. However, in line with the results of the study on virtual glasses, it is thought that the application of virtual glasses will also have a positive effect on the Reactive (Negative) Non-Stress Test result by reducing the anxiety level of pregnant women and increasing fetal movement and fetal cup speed in pregnant women with NST.
This study was planned to examine the effects of virtual reality glasses, one of the cognitive behavioral techniques, on fetal movement, fetal heart rate, maternal satisfaction and anxiety level.
Read the detailed description
One of the parameters used in the evaluation of fetal health during pregnancy is the Non-Stress Test (NST). When a healthy fetus moves, the oxygen requirement increases, the fetus increases the cardiac output to meet this requirement, and this is reflected in the trace as acceleration. Increased fetal heart rate during fetal movements; Adequate oxygenation, healthy transmission between the fetal central nervous system and the heart, and the ability of the fetus to respond to stimuli indicate fetal well-being (4, 23). This physiological response of the fetus is evaluated with the Non-Stress Test. The best result of this test is between 30-32 days of pregnancy when the fetal central nervous system development is completed. It is applied starting from these weeks in order to evaluate fetal health in routine pregnancy follow-ups (4). The results of the Non-Stress test are evaluated under two headings: Reactive (negative) and non-reactive (positive) NST. 1) Reactive (Negative) Non-Stress Test: At least two fetal movements within 20 minutes, fetal heart rate (FKA) being more than 15 beats (increase) than basal fetal heart rate in parallel with the movements, and accelerations lasting more than 15 seconds (fetal heart rate increases). 2) Non-reactive (Positive) Non-Stress Test: It is the situation in which there are accelerations (fetal heart rate increases) that are less than 15 beats and last less than 15 seconds despite the absence of fetal movements or fetal movements (4). The expected result in a healthy fetus is the Reactive (Negative) Non-Stress Test result. In the study of one it was found that 95% of the pregnant women were followed up for NST in the antepartum period (18).
The results of the Non-Stress test; Variables in the external environment (such as maternal abdominal palpation, voice, and fetal sleep) may affect the procedure (4). In the literature, it has been reported that some practices such as listening to music while applying the Non-Stress test, relaxation exercises and relaxation training increase the Reactive (Negative) Non-Stress Test result expected in fetal well-being, increase the average number of accelerations, and cause a significant decrease in the level of anxiety in pregnant women (1,3,6,12,13,19,21-25). It was reported that the mean number of accelerations was 8.9±3.9 in pregnant women who were listened to music during NST application, and 4.3±3.2 in pregnant women who were not listened to. Again, in this study, NST results were reported as reactive in 98.0% of pregnant women who were listened to music and 66% of those who were not listened to (6). Similarly, while Küçükkelepçe and Timur Taşhan's (2018) average number of accelerations while listening to music was 2.14 ± 1.12, the average number of accelerations in the control group was 1.29 ± 1.09. reported (19). In addition, in the study of In the study of one in which they examined the effect of relaxation training on the reactivity of NST, they reported that the rate of reactive NST in relaxation training was 53.2%, while the rate of non-reactive NST was 46.8% (1). Based on these studies in the literature, it is seen that these practices within the scope of midwifery care practices have an effect on the NST results. In recent years, virtual reality glasses application as one of these applications has taken its place in the literature. Although virtual reality glasses technology is a device, it has been widely used in the medical field in hospitals. When the literature is examined, it is seen that virtual reality glasses reduce the level of anxiety and reduce the perception of fatigue level (20, 7, 10, 11). In the literature, in a meta-analysis study on the effectiveness of VR glasses on pain and anxiety in pediatric patients undergoing medical procedures, it was reported to be effective in reducing anxiety (SMD = 1.32; 95% CI, 0.21-2.44; P = .020) (29). In another meta-analysis, it is seen that virtual reality glasses are effective in reducing pre-operative anxiety (30) Again,one in the study of It has been reported that they have pre-anxiety anxiety and that virtual reaIn the study of onelity glasses can be a potential tool to provide low perception of fatigue levels (20).
- Conditions
- Virtual Reality
- Being tested
- Virtual Reality Glasses
- Keywords
- Virtual Reality, Fetal Movement, Fetal Heart Rate, Anxiety
- 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 GlassesDevice
Virtual Reality Glasses
| Study group | Role | What they receive |
|---|---|---|
| Workgroup | Experimental | The probes will be fixed by giving the left lateral position for NST to the pregnant women in the intervention group by the researcher. After providing internet connection with a smart phone for the image, by clicking on youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video watching virtual reality glasses will be provided. The name and surname of the pregnant woman will be written on the NST trace and the trace will be photographed. After the NST process is completed, the NST traces will be evaluated by the researchers. Receives: Device: Virtual Reality Glasses |
| Control | No intervention | Unlike the study group, only video monitoring will not be applied to the pregnant women included in the control group. Other applications will be done in the same way. |
What is being measured
The primary outcome is the main question the study is designed to answer.
When virtual reality glasses are applied during the Non-Stress test application; (1) increase fetal heart rate and fatal heart rate?
occurring at least 2 times within a maximum of 20 minutes, at least 15 beats/min more than basal level and lasting for 15 seconds
Measured: through study completion, wenty minutes
When virtual reality glasses are applied during the Non-Stress test application; (2) increases maternal satisfaction?
The scale is a 5-point Likert-type scale consisting of 19 items including nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100. The increase in the total score obtained from the scale indicates that the patients' satisfaction with nursing is high.
Measured: through study completion, twenty minutes
When virtual reality glasses are applied during the Non-Stress test application; Does it reduce the level of maternal anxiety?
Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
Measured: through study completion, twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2021
- Study completion30 Jun 2021
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.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mine Gokduman Keles
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mine Gokduman Keles, Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093283
- Sponsor's protocol ID
- TurkishMoHKahramanmarasPH
- Acronym
- Virtual
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Fetal Movement, Fetal Heart Rate, Maternal Satisfaction and Anxiety Level
- ClinicalTrials.gov ID
- NCT05093283
- Acronym / sponsor ID
- Virtual / TurkishMoHKahramanmarasPH
- Conditions
- Virtual Reality
- Keywords
- Virtual Reality, Fetal Movement, Fetal Heart Rate, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Mine Gokduman KelesOther government
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Oct 2021 (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.
When the literature is examined, it is seen that virtual reality glasses are used during medical procedures, have an anxiety-lowering effect and have a reducing effect on the perception of fatigue (20, 7, 10, 11). On the other hand, no study has been found in the literature on the application of virtual glasses to pregnant women who underwent NST. However, in line with the results of the study on virtual glasses, it is thought that the application of virtual glasses will also have a positive effect on the Reactive (Negative) Non-Stress Test result by reducing the anxiety level of pregnant women and increasing fetal movement and fetal cup speed in pregnant women with NST.
This study was planned to examine the effects of virtual reality glasses, one of the cognitive behavioral techniques, on fetal movement, fetal heart rate, maternal satisfaction and anxiety level.
Detailed description
One of the parameters used in the evaluation of fetal health during pregnancy is the Non-Stress Test (NST). When a healthy fetus moves, the oxygen requirement increases, the fetus increases the cardiac output to meet this requirement, and this is reflected in the trace as acceleration. Increased fetal heart rate during fetal movements; Adequate oxygenation, healthy transmission between the fetal central nervous system and the heart, and the ability of the fetus to respond to stimuli indicate fetal well-being (4, 23). This physiological response of the fetus is evaluated with the Non-Stress Test. The best result of this test is between 30-32 days of pregnancy when the fetal central nervous system development is completed. It is applied starting from these weeks in order to evaluate fetal health in routine pregnancy follow-ups (4). The results of the Non-Stress test are evaluated under two headings: Reactive (negative) and non-reactive (positive) NST. 1) Reactive (Negative) Non-Stress Test: At least two fetal movements within 20 minutes, fetal heart rate (FKA) being more than 15 beats (increase) than basal fetal heart rate in parallel with the movements, and accelerations lasting more than 15 seconds (fetal heart rate increases). 2) Non-reactive (Positive) Non-Stress Test: It is the situation in which there are accelerations (fetal heart rate increases) that are less than 15 beats and last less than 15 seconds despite the absence of fetal movements or fetal movements (4). The expected result in a healthy fetus is the Reactive (Negative) Non-Stress Test result. In the study of one it was found that 95% of the pregnant women were followed up for NST in the antepartum period (18).
The results of the Non-Stress test; Variables in the external environment (such as maternal abdominal palpation, voice, and fetal sleep) may affect the procedure (4). In the literature, it has been reported that some practices such as listening to music while applying the Non-Stress test, relaxation exercises and relaxation training increase the Reactive (Negative) Non-Stress Test result expected in fetal well-being, increase the average number of accelerations, and cause a significant decrease in the level of anxiety in pregnant women (1,3,6,12,13,19,21-25). It was reported that the mean number of accelerations was 8.9±3.9 in pregnant women who were listened to music during NST application, and 4.3±3.2 in pregnant women who were not listened to. Again, in this study, NST results were reported as reactive in 98.0% of pregnant women who were listened to music and 66% of those who were not listened to (6). Similarly, while Küçükkelepçe and Timur Taşhan's (2018) average number of accelerations while listening to music was 2.14 ± 1.12, the average number of accelerations in the control group was 1.29 ± 1.09. reported (19). In addition, in the study of In the study of one in which they examined the effect of relaxation training on the reactivity of NST, they reported that the rate of reactive NST in relaxation training was 53.2%, while the rate of non-reactive NST was 46.8% (1). Based on these studies in the literature, it is seen that these practices within the scope of midwifery care practices have an effect on the NST results. In recent years, virtual reality glasses application as one of these applications has taken its place in the literature. Although virtual reality glasses technology is a device, it has been widely used in the medical field in hospitals. When the literature is examined, it is seen that virtual reality glasses reduce the level of anxiety and reduce the perception of fatigue level (20, 7, 10, 11). In the literature, in a meta-analysis study on the effectiveness of VR glasses on pain and anxiety in pediatric patients undergoing medical procedures, it was reported to be effective in reducing anxiety (SMD = 1.32; 95% CI, 0.21-2.44; P = .020) (29). In another meta-analysis, it is seen that virtual reality glasses are effective in reducing pre-operative anxiety (30) Again,one in the study of It has been reported that they have pre-anxiety anxiety and that virtual reaIn the study of onelity glasses can be a potential tool to provide low perception of fatigue levels (20).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workgroup | Experimental | Device: Virtual Reality GlassesThe probes will be fixed by giving the left lateral position for NST to the pregnant women in the intervention group by the researcher. After providing internet connection with a smart phone for the image, by clicking on youtube.com link, Relaxation (https://www.youtube.com/watch?v=H1iboKia3AQ) nature video watching virtual reality glasses will be provided. The name and surname of the pregnant woman will be written on the NST trace and the trace will be photographed. After the NST process is completed, the NST traces will be evaluated by the researchers. |
| Control | No intervention | –Unlike the study group, only video monitoring will not be applied to the pregnant women included in the control group. Other applications will be done in the same way. |
Who may qualify
- Ages
- 32 to 40 weeks
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Between the ages of 18-45,
- Healthy pregnant women,
- No cardiovascular disease diagnosed in the fetus,
- Having completed the 32nd gestational week,
- Having eaten at least two hours before the NST procedure,
Key exclusion criteria (3 listed)
- • Pregnant women with fetal distress and for whom emergency intervention is considered by the physician,
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 GlassesVirtual Reality Glasses | Device | Workgroup |
Primary outcome
When virtual reality glasses are applied during the Non-Stress test application; (1) increase fetal heart rate and fatal heart rate?
Time frame: through study completion, wenty minutes
occurring at least 2 times within a maximum of 20 minutes, at least 15 beats/min more than basal level and lasting for 15 seconds
When virtual reality glasses are applied during the Non-Stress test application; (2) increases maternal satisfaction?
Time frame: through study completion, twenty minutes
The scale is a 5-point Likert-type scale consisting of 19 items including nursing care. All items of the Newcastle Nursing Care Satisfaction Scale are positive. In the scoring used to determine the degree of satisfaction, there are statements such as "Not at all Satisfied=1 point, Slightly Satisfied=2 points, Fairly Satisfied=3 points, Very Satisfied=4 points, Extremely Satisfied=5 points". The scores given to the questions of all items marked on the score evaluation scale are added together. The maximum score obtained from the scale is 95, and the minimum score is 19. Evaluation is made by converting the total score obtained from the scale to 100. The increase in the total score obtained from the scale indicates that the patients' satisfaction with nursing is high.
When virtual reality glasses are applied during the Non-Stress test application; Does it reduce the level of maternal anxiety?
Time frame: through study completion, twenty minutes
Scoring in the State Anxiety Scale varies between 20-80 points. A score of less than 36 is considered no anxiety, a score of 37-42 is considered mild anxiety, and a score of 42 and above is considered high anxiety.
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 26 Oct 2021.
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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 Glasses in people with Virtual Reality, run by Mine Gokduman Keles 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 7 inclusion and 3 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 26 Oct 2021. 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?
When virtual reality glasses are applied during the Non-Stress test application; (1) increase fetal heart rate and fatal heart rate? (time frame: through study completion, wenty minutes). 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 26 Oct 2021.