Viewing Study NCT05723666



Ignite Creation Date: 2024-05-06 @ 6:37 PM
Last Modification Date: 2024-10-26 @ 2:51 PM
Study NCT ID: NCT05723666
Status: ENROLLING_BY_INVITATION
Last Update Posted: 2023-02-13
First Post: 2022-01-21

Brief Title: The Effect of Virtual Reality Glasses on Fear of Birth Delivery Time and Non-Stress Test Results in Pregnancy in the Process of Labor
Sponsor: Akdeniz University
Organization: Akdeniz University

Study Overview

Official Title: The Effect of Virtual Reality Glasses on Fear of Birth Delivery Time and Non-Stress Test Results in Pregnancy in the Process of Labor A Randomized Controlled Single-Blind Study
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2023-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 mothers 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 womens 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
Detailed 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 womens 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 mothers 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 mothers intake of sufficient fluid the mothers 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 mothers 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 mothers 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 ones 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 RealityVR 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 peoples 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 andor 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 womens 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 womans 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 mothers attention and providing relaxation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
Kamile KABUKCUOĞLU OTHER Akdeniz University None