Clinical trial NCT05093283: The Effect of Virtual Reality Glasses on Fetal Movement
Official title: The Effect of Virtual Reality Glasses on Fetal Movement, Fetal Heart Rate, Maternal Satisfaction and Anxiety Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality
Keywords: Virtual Reality
Fetal Movement
Fetal Heart Rate
Anxiety
Lead sponsor: Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
Sponsor class: OTHER_GOV
First posted: 2021-10-26
Enrollment: 87
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* • 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.

Primary outcomes:
measure: When virtual reality glasses are applied during the Non-Stress test application; (1) increase fetal heart rate and fatal heart rate?
timeFrame: through study completion, wenty minutes
measure: When virtual reality glasses are applied during the Non-Stress test application; (2) increases maternal satisfaction?
timeFrame: through study completion, twenty minutes
measure: When virtual reality glasses are applied during the Non-Stress test application; Does it reduce the level of maternal anxiety?
timeFrame: through study completion, twenty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: TurkishMoHKahramanmarasPH
state: Onikişubat
Study officials:
References: