The Effect of Immersive Virtual Reality and Music on Anxiety, Fear, and Pain During Circumcision Surgery in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Statistical difference between groups about fear scores
研究概览
简要总结
The goal of this randomized controlled trial is to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery.
The main question[s] it aims to answer are:
- Are immersive virtual reality and music interventions effective in reducing children's anxiety and fear levels during circumcision surgery?
- Are immersive virtual reality and music interventions effective in reducing children's pain levels during circumcision surgery? There were three groups in the study: control group (n:24), immersive virtual reality group (n:24), and music group (n:24). The control group did not undergo any intervention and only the routine procedure of the clinic was performed. The participants in the immersive virtual reality group played an interactive video game. The participants in the music group listened to music of their preference.
详细描述
Aim: Circumcision is one of the surgical procedures causing fear and pain in children. This study aimed to examine the effectiveness of immersive virtual reality (IVR) and music on children's anxiety, fear, and pain levels during circumcision surgery.
Methods:The participants were divided into three groups: Immersive virtual reality group (n=24), music group (n=24), and control group (n=24). Data were collected using a Participant Information Form, the Children's Anxiety Meter-Scale (CAM-S), the Children's Fear Scale (CFS), and the Wong-Baker Faces Pain Rating Scale (WBS). Anxiety and fear levels of the children were measured before, during, and after the circumcision operation and their pain levels were measured during and after circumcision. The study was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive statistics, analysis of variance, t-test, and Duncan and Bonferroni tests were performed for data analysis.
Intervention protocols: As a routine procedure in the clinic where the study was conducted, the children to be circumcised were admitted to the clinic in the morning on the day of the procedure, and routine preparations for the operation were completed. When the children and their families came to the clinic immediately after hospitalization, they were informed about the study by one of the researchers, and their written and verbal consent was obtained. Then the data were collected using an introductory information form, the Children's Anxiety Meter-Scale (CAM-S), and the Children's Fear Scale (CFS). Children who met the selection criteria were divided into groups by randomization method.
After the children in the experimental groups were taken to the waiting room in the operating room, they were informed by the researcher who would perform the intervention. The researcher explained the use of virtual reality glasses to the children in the IVR group and the use of music headphones to the children in the music group. Each child in the music group was allowed to choose the music he wanted to listen to during the circumcision. The children were also informed that the intervention would be stopped if they experienced motion sickness, eye discomfort, headache, or earache. In the interview with the children in the music group, the type of music they listened to in their daily lives was asked and the music they wanted to listen to during circumcision was determined. Each child in the IVR group was allowed to choose the VR game he wanted to play during the circumcision. Routine procedures were applied for the control group.
Intervention phase:In this study, one group received IVR intervention, and the other group received music intervention to distract the child during the circumcision operation. One of the researchers (an academic with a PhD degree in pediatric nursing) was certified as a music therapy practitioner and had knowledge and experience in virtual reality. The interventions were carried out by this researcher. The researcher complied with the principles of medical and surgical asepsis in the operating room. Just before the intervention, the researcher put the virtual reality glasses on the children in the IVR group and gave the remote controls to their hands. The children in the music group wore music headphones.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor) Triple-blind (i.e., triple-masking) studies are randomized experiments in which the treatment or intervention is unknown to (a) the research participant, (b) the individual(s) who administer the treatment or intervention, and (c) the individual(s) who assess the outcomes
入排标准
- 年龄范围
- 6 Years 至 8 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Circumcision in a pediatric surgery clinic
- •Agreeing to participate in the study
- •Having no visual and hearing problems, having no history of surgical intervention, and having no chronic pain or mental health problems
排除标准
- •Presence of contraindications for the procedure (hypospadias, epispadias, bleeding disorders, anatomical disorders),
- •Use of any painkillers 24 hours before the procedure,
- •Presence of communication problems.
结局指标
主要结局
Statistical difference between groups about fear scores
时间窗: During the procedure approximately 10 minutes
Implementation of interventions aimed at reducing fear in experimental groups. Children's Fear Scale:This scale is used in clinical settings to assess children's fear during invasive procedures.The scale consists of five gender-neutral facial expressions, ranging from neutral on the far left to extremely fearful on the far right. The evaluation of facial expressions ranges between 0-4 points.
Statistical difference between groups about anxiety scores
时间窗: During the procedure approximately 10 minutes
Implementation of interventions aimed at reducing anxiety in experimental groups. Children's Anxiety Meter-Scale:This scale is used in clinical settings to assess children's anxiety during invasive procedures. Scores obtained from the scale range from 0 to 10.
Statistical difference between groups about pain scores
时间窗: During the procedure approximately 10 minutes
Implementation of interventions aimed at reducing pain in experimental groups. Wong-Baker Faces Pain Rating Scale:This scale was developed by Wong and Baker to evaluate pain in children aged 3-18. Scores on the numerical rating scale range from 0 to 10. The scale shows a series of faces ranging from a smiling face (0=very happy/no pain) to a crying face (10=high pain)
次要结局
未报告次要终点
研究者
Hamide Nur Çevik Özdemir
Asst.prof.
Afyonkarahisar Health Sciences University
