Immersive Virtual Reality and Music During Circumcision in Children
Condition: Fear; Anxiety; Child
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      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:

        1. Are immersive virtual reality and music interventions effective in reducing children's
           anxiety and fear levels during circumcision surgery?

        2. 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.
    

Detailed description: 
      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.

      Circumcision operations were performed in the same operating room setting by the same
      pediatric surgeon and operating room team (assistant physician, anesthesia technician, three
      nurses, and the researcher). The thermocautery assisted guillotine technique was performed in
      all children during circumcision. Each circumcision operation took an average of 15 minutes
      for all children in the experimental and control groups. This period included the child's
      entry and exit to and from the operating room. During this period, the parents of all
      children waited in the waiting room outside the operating room.

      During the circumcision operation, the IVR group received both routine care and VR game. The
      children were allowed to play the virtual reality game of their choice. The children in the
      IVR group had an interactive gaming experience for 10 minutes with the game of their choice,
      using the remote controls while lying on their backs on the operating table during
      circumcision.

      The children in the IVR group were offered two video games from the Oculus Quest gallery.
      These games were Ocean Rift and Epic Roller Coaster-T-Rex Kingdom. Ocean Rift is the world's
      first VR water safari park. It has 12 different marine animals such as dolphins, sharks, and
      turtles and a habitat. Here one can visit a vibrant underwater world that extends all the way
      to the Arctic and Atlantis. Epic Roller Coaster-T-Rex Kingdom takes one on a roller coaster
      ride through the Age of Dinosaurs. There are more than 10 species of dinosaurs such as
      terrestrial, flying, herbivorous and carnivorous. The aforementioned VR video games are
      commercially available and were obtained from the Oculus Quest 2 Store
      (https://www.oculus.com/experiences/quest/).

      A disposable silicone pad was placed on the Oculus Quest before each use. To minimize direct
      contact with the device, the patients wore disposable headgear and a face mask (personal
      protective equipment) before use. The parts of the device in contact with children's faces
      were cleaned before each intervention.

      The children in the music group listened to music at the same volume (60 dB), with the same
      type of headphones, and the same iPad. The children listened to the music of their choice for
      10 minutes after wearing the headphones. In musical interventions, it is recommended to play
      music chosen by individuals. Disposable ear pads were used for each child and the headphones
      were cleaned after each intervention.

      Children in the control group received routine care and no intervention was performed.
      Anxiety, fear, and pain of the children in the experimental and control groups were
      re-evaluated 10 minutes after circumcision by the children and an external observer using the
      Children's Anxiety Meter-Scale (CAM-S), the Children's Fear Scale (CFS), and the Wong-Baker
      Faces Pain Rating Scale (WBS).
    

Intervention name(s): Immersive virtual reality group; Music group
Intervention type(s): Other; Other
Intervention description(s): The children in the IVR group were offered two video games from the Oculus Quest gallery. These games were Ocean Rift and Epic Roller Coaster-T-Rex Kingdom. Ocean Rift is the world's first VR water safari park. It has 12 different marine animals such as dolphins, sharks, and turtles and a habitat. Here one can visit a vibrant underwater world that extends all the way to the Arctic and Atlantis. Epic Roller Coaster-T-Rex Kingdom takes one on a roller coaster ride through the Age of Dinosaurs. There are more than 10 species of dinosaurs such as terrestrial, flying, herbivorous and carnivorous.; In musical interventions, it is recommended to play music chosen by individuals. Disposable ear pads were used for each child and the headphones were cleaned after each intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized controlled experimental study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Immersive Virtual Reality; Music; Pain; Circumcision