Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05093283 |
| Other study ID # |
TurkishMoHKahramanmarasPH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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).
