The Effect of Virtual Reality Video and Mandala Coloring Activity on Anxiety Levels, Satisfaction and Non-Stress Test Results of Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The Effect of Virtual Reality Video and Mandala Coloring Activity on Non-Stress Test Results
研究概览
简要总结
Non-stress testing (NST) is one of the most commonly used non-invasive tests to assess fetal health. NST is widely used because it is non-invasive and easy to interpret. However, although it is a painless procedure, pregnant women may experience anxiety during the procedure. The high level of anxiety experienced by the pregnant woman during the NST procedure affects the test result and may increase the rate of non-reactive NST, leading to misinterpretation. These false positive rates of NST lead to an increase in cesarean section rates. Recent studies have shown that methods that increase fetal movements and shorten the duration of NST are used. When the literature is examined, it is seen that non-pharmacological methods such as music therapy, virtual reality and abdominal touching applied during the NST procedure reduce the anxiety of pregnant women and positively affect the NST results. With this proposed project, it is aimed to determine the Effect of Virtual Reality Video and Mandala Coloring Activity on Anxiety Levels, Satisfaction and Non-Stress Test Results of Pregnant Women.
The study is a randomized controlled experimental type study in pretest-posttest design and the population of the study will consist of pregnant women who applied to Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Obstetrics and Gynecology Outpatient Clinic and were referred to NST. Simple randomization method will be used while sampling the pregnant women. The power analysis was performed under 95% power (1-β), number of groups=3 and α=0.05, and in the light of these parameters, it was concluded that a sample size of at least 90 participants was required for this study. In case of data loss, it was envisaged to increase the sample size by 20%. Accordingly, the project was planned to be conducted with a total of n=108 participants, with 36 pregnant women in each group. After the ethics committee permission, institutional permission will be obtained from Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital. Data will be collected using the "Personal Introduction Form", "State Anxiety Scale", "NST findings record form" in which NST findings are recorded, and Visual Analog Scale-Satisfaction Form to evaluate their satisfaction after NST.
详细描述
In the first part of the study, pregnant women who apply to Kahramanmaraş Sütçü İmam University Health Practice and Research Hospital Obstetrics and Gynecology Outpatient Clinic and are referred to NST and meet the inclusion criteria will be informed about the project and verbal and written consent will be obtained. In this direction, survey questions will be directed to pregnant women who agree to participate in the study. In the study, pre-test data will be obtained with 13-question Participant Introduction Form and 20-question State Anxiety Scale forms. Post-test data will be obtained after the NST procedure is completed for the experimental groups, the researcher will ask the State Anxiety Scale, VAS-Satisfaction form by face-to-face interview method and the NST Findings Record Form will be filled by the researcher.
and the explanations made to the pregnant women before the procedure will be made in a room outside the NST room.
Randomization Pregnant women included in the study will be randomized with the single-blinded randomized rule. Randomization will be done by using the random integer generator method in the numbers subheading of the random.org website, and three-group columns will be created with numbers from 1 to 108. At the beginning of the study, lots will be drawn to determine which of the 3 columns will be the experimental groups and which will be the control group. When there is a participant who meets the inclusion criteria, the participant will be included in whichever group the next number is in.
Data Collection Tools Data will be collected using the Personal Introduction Form, which determines the socio-demographic and obstetric characteristics of women and their knowledge about NST, the State Anxiety Scale, the NST Findings Record Form, which includes the findings related to NST, which allows the researchers to evaluate the NST result of pregnant women, and the Visual Analog Scale (VAS) - Satisfaction Form to evaluate their satisfaction after NST.
Personal Introduction Form This form was created by the researchers to determine women's sociodemographic (age, educational status, etc.), obstetric characteristics (pregnancy, abortion and number of living children) and knowledge about NST (receiving information about NST before, from whom they received the information, reason for NST withdrawal, etc.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be over 18 years of age,
- •Not having any chronic or metabolic disease (completely healthy pregnant women)
- •Not having any psychiatric illne
排除标准
- •-Multiple pregnancy
- •Contraction on NST communication and visual impairment, uterine contraction as a result of NST,
- •Have any chronic disease (such as diabetes mellitus, hypertension, heart failure),
- •Have pregnancy complications (such as pre-eclampsia, gestational diabetes, Rh incompatibility),
- •History of infertility and conceived with assisted reproductive techniques,
- •The fetus has an identified problem (such as anomaly, intrauterine growth retardation and cardiovascular disease),
- •Pregnant women who provided false or incomplete information were excluded from the study.
研究组 & 干预措施
Virtual Glasses Group
Pregnant women assigned to the Virtual Reality Group will watch a virtual reality (VR) video through a VR headset connected to a smartphone during the non-stress test (NST) procedure while lying in the left lateral position. The VR video will feature natural scenery accompanied by relaxing nature sounds, such as flowing water and birdsong. Before the intervention, participants will receive instructions on the use of the VR headset and will be informed that they may discontinue viewing the video at any time if they experience any discomfort. Since VR exposure may cause nausea or vomiting, the recommended viewing duration is 5-20 minutes. As this study involves pregnant women, the VR video will be presented for 5-10 minutes.
干预措施: Virtual Glasses Group (Device)
Mandala Coloring activity group
Mandala Coloring activity group; In studies examining the effect of art therapy on the reduction of psychological symptoms, it has been shown that the use of round patterns is more effective in symptom management.(24) In line with these studies, ready-made mandala coloring templates with round shapes will be used in our study (25,26). Each participant will be asked to choose one of the mandala coloring templates. Each participant will be given colored pencils and asked to color the mandala template of their choice during the NST (27,28).
After the procedure is completed, the pregnant women will be asked the State Anxiety Scale, VAS-Satisfaction form and the NST Findings Record Form will be completed by the researcher.
干预措施: Mandala Coloring activity group; (Other)
Control Group
Pregnant women in the control group will undergo standard outpatient clinic practice. Pregnant women in the control group will be asked Personal Information Form and State Anxiety Scale form questions in the pretest. After the procedure is completed, the pregnant women will be asked the State Anxiety Scale, VAS-Satisfaction form in the post-test and the NST Findings Record Form will be completed by the researcher.
结局指标
主要结局
The Effect of Virtual Reality Video and Mandala Coloring Activity on Non-Stress Test Results
时间窗: 20 minutes later
Reactive Non-Stress Test Results
次要结局
未报告次要终点
研究者
Fatma Keskin Töre
Assistant Professor, PhD
Kahramanmaras Sutcu Imam University