Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05723666 |
| Other study ID # |
Mine ORUÇ |
| Secondary ID |
Kamile KABUKCUOG |
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2022 |
| Est. completion date |
January 30, 2023 |
Study information
| Verified date |
February 2023 |
| Source |
Akdeniz University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
From the gestation period, labor affects the mother due to both physical and emotional
changes. Mothers experience new emotions and experiences since their admission to the
delivery room. With the progression of the mother's physiological changes and labor in the
delivery room, new situations arise. Although the birth process is a complex process, it can
vary from person to person. In the delivery room, many preparations and applications are made
for labor. A positive pregnancy and childbirth will affect both the motherhood process and
later life periods. Every day, new applications are added to the applications made for the
mother to leave the labor satisfied. Virtual reality (VR) glasses application has features
such as relaxation, distraction, reducing focus on pain, painful and stressful applications.
When the literature is examined, SG glasses are generally focused on pain in the field of
women's health. In this study, it is aimed to evaluate the effect of watching videos with SG
glasses on the fear of childbirth, NST results and delivery time by using the distraction
feature of the mother in the delivery room. The study included mothers who came to Antalya
Training and Research Hospital delivery room for vaginal delivery, aged 18-35, had no hearing
and vision problems, had an uneventful pregnancy, and had no chronic disease in the fetus or
mother. A total of 128 mothers with 64 experimental (32 primiparous, 32 multiparous), 64
control groups (32 primiparous, 32 multipara) and a total of 128 mothers will be included in
the study by power analysis. For the randomization of this study, which was planned as a
randomized controlled trial, "simple randomization method" stratified sampling, which was
admitted to the delivery room and met the inclusion criteria, was used. In the study, mothers
in the experimental group will be shown a nature video with SG glasses during the NST
procedure. No intervention other than routine delivery room care will be applied to the
control group. At the end of the study, it is expected that the level of fear of birth will
decrease, the NST will be reactive, and the duration of labor will decrease with the relief
of the mothers' SG glasses.
Description:
The birth of a baby is expressed as a unique life experience for every mother. From the
pregnancy period, labor affects the mother to a great extent due to both physical and
emotional changes. Mothers experience new emotions and experiences since their admission to
the delivery room. Birth is a situation where fear, sadness, pain, happiness and joy are
experienced together. For this reason, the practices made since the admission of women to the
delivery room include an unforgettable experience in women's life.
Labor takes place in a total of four stages, including the onset and completion of effacement
and dilatations, the tightening of contractions, the birth of the baby, the birth of the
placenta and membranes, and the first four hours afterward. Although the duration of delivery
may vary in multiparous and primiparous cases, it should not exceed 24 hours. It has been
reported that pregnant women admitted to the delivery room before the active phase stay in
the delivery room more, spend labor alone, face more negative situations, and have more
stress due to monitoring and analgesia.
Fetal monitoring, induction application, enema, cervical examination, use of analgesia to
reduce labor pain for monitoring maternal and fetal health during labor, Applications such as
bladder catheter, episiotomy, dose and duration of epidural anesthesia are performed and
these applications directly affect the duration of delivery and the length of stay of the
mother in the delivery room. Despite all these practices, it is not yet known what the most
effective and successful method for initiating and accelerating labor is. In addition to the
pharmacological and mechanical methods applied, non-pharmacological and supportive care
practices in labor, which are more preferred by women, are also being developed.
In recent years, the idea that childbirth is a natural process that is disrupted by medical
interventions has become increasingly common. If the needs of the pregnant woman are known
and respected during labor, it is aimed to reduce the need for non-medical supportive care,
which facilitates the pregnant woman to use coping methods more, and aims to reduce her
anxiety, discomfort, loneliness and fatigue, and to reduce excessive and unnecessary
interventions. The use of applications for non-pharmacological care in the labor process is
increasing day by day. Acupressure, acupuncture, music therapy, massage treatments, breathing
techniques, yoga, hypnosis. Methods such as focusing, distraction, daydreaming, hydrotherapy
can be used. Non-pharmacological methods do not prolong the delivery period and attract
attention as they have no side effects, no allergy risk, are economical, reliable and easy to
use. There is a need for further development of these methods, which are found by trial and
error in different countries.
From the mother's admission to the delivery room, many preparations and practices are made
for labor. Non-invasive non-stress testing (NST) is frequently used in the evaluation of the
well-being of the mother and the baby in the delivery room. The nonstress test is a test used
to monitor the heartbeat of the fetus, and to determine the relationship between fetal
movements and uterine contractions, if any. The NST is evaluated for at least 20 minutes
while the expectant mother is lying on her back or on her left side. A reactive NST is
expected to have at least 2 accelerations within 20 minutes and short-term variability to be
moderate. NST without at least 2 accelerations for 20 minutes, up to 40 minutes If it still
fails, it is considered as non-reactive NST. NST is one of the most important methods used in
pregnancy follow-ups to show fetal well-being. The most important disadvantage is the need
for further extension of the test period and repetition due to reasons such as long
application time and non-reactive NST. The NST can be affected by the mother's intake of
sufficient fluid, the mother's hunger or satiety, drug or smoking status, excitement, fear
and stress level, and the noise level of the environment. Many non-pharmacological methods
are tried to improve maternal and fetal outcomes in NST. It has been reported that music,
stress and anxiety during the NST procedure, relaxing hypnotherapy, and distraction methods
reduce anxiety in pregnant women and lead to an increase in the number of fetal movements and
accelerations.
Pain due to contractions during labor, experiences related to the moment of birth, birth
stories heard from others, uncertainty, mother's stress state, routine care given in the
delivery room cause fear and stress. Practices in the delivery room, loneliness due to the
length of stay and uncontrollable psychological support may cause fear of childbirth in
pregnant women. Fear of childbirth; It is an anxiety that starts before pregnancy and
includes the fear of birth and death. This situation, which may differ in every woman, cause
negative consequences in women, and intensify gradually, is defined as "Tokophobia". Other
important reasons that trigger the fear of childbirth; Problematic birth experiences such as
risky pregnancy history, listening to or watching fearful experiences of others, difficult
labor with vacuum or forceps intervention, history of anomaly or stillbirth, history of
excessive blood loss during delivery, emergency cesarean section decision, emergencies during
delivery is the mother's inability to receive adequate social support during pregnancy and
delivery.
Prevalence of fear of childbirth in pregnant women; sociodemographic, obstetric and cultural
differences. Not knowing the methods of coping with the fear of childbirth further
complicates the situation. It is known that the care given in the delivery room shortens the
duration of labor, reduces the fear of childbirth, is exposed to less pharmacological support
and obstetric intervention, decreases the risk of perinatal complications, episiotomy
application, oxytocin use and cesarean section rates. As non-pharmacological methods to
reduce fear of childbirth, breathing exercises, hydrotherapy, meditation, breathing
exercises, daily walks, hypnotic birth, yoga, social support and birth information training
given in pregnant schools were found to be effective in reducing fear of birth .
Although most women describe childbirth as a powerful and positive experience, some women may
feel helpless, detached from life and abandoned during childbirth. Stress, anxiety, fear,
labor pain, fear of the unknown regarding childbirth, distrust of caregivers increase the
secretion of catecholamines, cortisone and epinephrine. For this reason, the duration of
delivery, non-stress test results and fear of childbirth are negatively affected. In recent
years, simple and easy non-pharmacological methods to manage these conditions and reduce
negative effects have come to the fore. Distraction methods are focused on the basis of the
non-pharmacological methods applied.
Distraction is focusing one's attention from the current situation to another situation. It
is used in many ways for distraction. There is information that listening to music, watching
videos, exercising, reading a book, breathing techniques or handicraft activities attract
attention at a substantial level. The person can distance himself from situations such as
fear, stress and anxiety, which he feels with distraction methods. Regardless of the method
used, distraction helps to relax and get away from stress.
World Health Organization, technology in health services; It is defined as the application of
organized knowledge and capabilities developed through systems, vaccines, drugs, devices
developed to improve quality of life and solve health problems. It is reported that these
devices have been developed to increase the quality of care, to correct or change body
functions, apart from the purposes such as the prevention, diagnosis and treatment of
diseases. In recent years, new technologies have been used in the care applied in nursing
services. Virtual reality (Virtual Reality/VR) has many application areas related to care and
treatment in the health sector. VR technology is used as a tool to support surgery, health
care services, rehabilitation of patients and exercise, education of patients, healthcare
workers and clinical students, and preventive and caregiver health services in clinical
applications.
Virtual reality is defined as "a technology that gives the feeling that three-dimensional
pictures and animations created in the computer environment are in a real environment in
people's minds with technological tools and enables them to interact with these objects in
the environment". It usually allows the person to interact in this new world, by using
technology to create a dimension that the person experiences as reality in the virtual
environment. The purpose of VR is to make the user believe that they are in a
computer-generated environment as much as possible. VR simulators are technically advanced
and available in a variety of sizes and shapes. VR provides a three-dimensional environment,
including a head-mounted device, 3D-capable glasses, headsets, and/or other similar sensors.
Thanks to its audio and visual settings, it is possible to interact with a simulated,
lifelike or fantastic environment.
Virtual reality glasses (Visual Reality-VR) are used as a tool to support preventive health
services in clinical applications. VR, which is among the technological products, can be used
in non-pharmacological methods as well as pharmacological methods. Although there are
discussions about the harms and benefits of non-pharmacological use, there are many studies
in the literature showing that it is effective. The effect is directly proportional to the
level of the patient in the virtual environment. Patient interaction is a uniquely effective
method of distraction (compared to video or audio stimulation) as it is multidimensional,
immersive, and interactive. In general, VR has been described as an effective tool for
distraction in medical procedures.
One of the recent uses of virtual reality is women's health. Studies in this area have found
that virtual reality is an effective non-pharmacological method to reduce pain and anxiety
during labor. It is stated that daydreaming or music during labor has an effect on
distraction and relaxation. However, because sometimes dreaming and dreaming can be difficult
for women, watching videos with virtual reality glasses is a good alternative.
Life is a continuous process, each phase of which affects the next. Childbirth and motherhood
are considered the most important stages of a woman's life. A positive pregnancy and
childbirth will affect both the motherhood process and later life periods. Every day, new
applications are added to the applications made for the mother to leave the labor satisfied.
Virtual glasses application has features such as relaxation, distraction, reducing focus on
pain and painful applications. In this study, it is aimed to evaluate the effect of fear of
childbirth, NST results, and duration of delivery by watching the video with virtual reality
glasses in the delivery room, distracting the mother's attention and providing relaxation.
