THE EFFECT of VİRTUAL REALİTY HEADSETS on ANXİETY, FEAR, and PHYSİOLOGİCAL PARAMETERS in CHİLDREN With CANCER UNDERGOİNG INTRATHECAL CHEMOTHERAPY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The Child Anxiety Scale-State Scale (CAS-S)
研究概览
简要总结
This study was planned to determine the effect of virtual reality glasses on anxiety, fear, and physiological parameters in cancer patients aged 4-10 years undergoing intrathecal chemotherapy. The main questions that the study aimed to answer are as follows:
- Could virtual reality glasses affect the fear experienced by children undergoing intrathecal chemotherapy?
- Could virtual reality glasses affect the anxiety experienced by children undergoing intrathecal chemotherapy?
- Does virtual reality goggles have an effect on the physiological parameters of children undergoing intrathecal chemotherapy? Researchers will compare the effects of virtual reality glasses on fear, anxiety, and physiological parameters (heart rate, blood pressure, respiratory rate, and oxygen saturation) in children with cancer undergoing intrathecal chemotherapy to a control group that will not receive any intervention.
Cancer patients participating in the study will be given virtual reality glasses before intrathecal chemotherapy treatment.
详细描述
Cancer is a chronic disease with a long follow-up and treatment process that profoundly affects the lives of children and their families (1). Chemotherapy (CT) is one of the frequently used methods in cancer treatment (1,2). In children with cancer, CT is administered intraarterial, intraperitoneal, intrapleural, intravenous, intramuscular, subcutaneous, oral, and intrathecal (3). Intrathecal CT is a method developed to cross the blood-brain barrier after the administration of systemic chemotherapy (3). Intrathecal CT is frequently used in pediatric oncology clinics (4) and can cause pain, stress, anxiety, and fear in children (5). Before intrathecal CT, various distraction methods can be used to reduce the stress, anxiety, and fear experienced by the child (5). Distraction is one of the non-pharmacological methods used to better control and reduce stress, anxiety, and fear by focusing the individual's attention elsewhere (6,7). Due to its non-invasive nature and lack of known side effects, distraction methods have become the most frequently preferred methods in recent years; Examples of distraction methods include blowing a pinwheel, watching cartoons/animations and playing games on a phone/computer, inflating balloons, reading books, counting numbers, listening to music, kaleidoscopes, medical puppets, distraction cards, and virtual reality glasses (VRG) (8-13). VRG, which can alter visual, auditory, and tactile sensations by creating a perception of being in a different environment, isolates the individual from real life by showing digital images (games, animations, etc.) through a headset with a lens close to the eyes. At the same time, individuals can be immersed in the virtual world by wearing headphones to prevent the perception of sounds in the environment. In these aspects, VRG is a different method from other distraction methods in that it combines multiple sensory experiences and maximizes the sense of attention (6, 13-15). No study has been found that uses VRG to reduce anxiety, fear, and anxiety experienced by children before intrathecal chemotherapy. Therefore, this study was planned to determine the effect of pre-operative SGG (Supplementary Endoscopic Glycemia) on anxiety, fear, and physiological parameters experienced by children aged 4-10 years before intrathecal chemotherapy.
Research Hypotheses
The application of SGG to children aged 4-10 years undergoing intrathecal chemotherapy has the following effects:
H1: It has an effect on pre-operative anxiety.
H2: It has an effect on pre-operative fear.
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
- 4 Years 至 10 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outside the 4-10 age range,
- •have a chronic or genetic illness,
- •have an intellectual, visual, or hearing impairment,
- •cannot adapt to virtual reality glasses,
- •are uncooperative (both themselves and their parents),
- •neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.
排除标准
- •outside the 4-10 age range,
- •have a chronic or genetic illness,
- •have an intellectual, visual, or hearing impairment,
- •cannot adapt to virtual reality glasses,
- •are uncooperative (both themselves and their parents),
- •neither they nor their parents are willing to participate in the research and have not given their verbal or written consent will not be included in the study.
研究组 & 干预措施
group using virtual reality glasses
In this study, children and their families who meet the inclusion criteria will be informed about the use of Virtual Reality Glasses, and the researcher will obtain an "Informed Consent Form." Before intrathecal chemotherapy, the Child and Family Demographic Characteristics Form and scales (thus determining the children's predicted levels of fear and anxiety before the procedure) will be administered to the children by the researcher, and the child's physiological parameters (heart rate, blood pressure, respiratory rate, oxygen saturation value) will be recorded by the researcher. Then, the children will be fitted with Virtual Reality Glasses by the researcher and shown a selected animation film (approximately 15 minutes long). Five minutes after the child finishes watching the video, the physiological parameters will be recorded again, and the scales will be administered by the researcher.
干预措施: virtual reality glasses (Other)
结局指标
主要结局
The Child Anxiety Scale-State Scale (CAS-S)
时间窗: 10 minutes before intrathecal chemotherapy and 5 minutes after the child finishes watching the video.
The Child Anxiety Scale-State Scale (CAS-S): This visual scale, designed for children aged 4-10, resembles a thermometer, featuring a lightbulb at the bottom and 10 horizontal lines leading upwards. When administering the scale, explain to the children: "Imagine all your anxious or tense feelings are at the top of the thermometer (point to it with your finger)," "If you are slightly anxious or nervous, the feelings may increase slightly (move your finger upwards on the scale)," "If you are very, very anxious or tense, the feelings may reach the top of the lines (move your finger to the top)," "Put a line that helps us understand how anxious or tense you feel." Before using the CAS-S, check if the child has counting and sequencing skills, specifically whether they know that 5 is greater than 2. If they do not know this, the scale cannot be administered to the child.
次要结局
未报告次要终点
研究者
Eda Kalayci
specialist nurse
TC Erciyes University
