THE EFFECT OF VIRTUAL REALITY ON CHILDREN'S ANXIETY, FEAR, AND PAIN LEVELS BEFORE CIRCUMCISION IN TURKEY
Condition: to Have a Circumcision Operation
Study type: Interventional

Summary: 
      Background: Circumcision is one of the most common surgical interventions in boys, and boys
      undergoing this procedure experience anxiety and fear during the preoperative period. In
      addition, postoperative pain in children is reported to be associated with anxiety and fear.

      Aim: This study aimed to examine the effects of using a virtual reality (VR) application
      before circumcision on the pre- and postoperative anxiety and fear levels and postoperative
      pain symptoms in children.

      Material and Methods: This randomized controlled experimental study included 5-to 10-year-old
      boys referred to a pediatric hospital for circumcision between June and September 2019.
      Randomization was performed using the randomized block design, and the subjects were divided
      into control (n = 38) and experimental (n = 40) groups. The data were collected using a
      participant information form, the children's fear scale (CFS), the children's anxiety meter
      scale (CAM-S), and the Wong-Baker Faces Pain Rating Scale; data were analyzed using SPSS 22.0
      package program. The data were evaluated using descriptive statistics; the chi-square test
      was used to assess the sociodemographic data, the Mann-Whitney U test was used to compare two
      independent groups, the Wilcoxon T-test was used to compare intra-group preoperative and
      postoperative values, and the Spearman Correlation test was used to examine the relationship
      between anxiety, fear and pain scores.

      Keywords: Circumcision, child, virtual reality, anxiety, fear, pain.
    

Detailed description: 
      This randomized controlled study was included 5-to 10-year-old boys who were referred to a
      pediatric hospital in Turkey for circumcision between June and September 2019. The sample
      size for the study was calculated using the G-Power 3.0.10 program and t-test for comparison
      of two independent groups with an effect size of 0.8, an alpha level and margin of error of
      0.05, and a power of 95%. The sample size was determined to be 70; each of the experimental
      and control groups included 35 children. Data were collected from 98 children. Of them, 14
      children were excluded from the study because two could not obtain approval from their
      families to participate in the study, four had previous surgical interventions, six had
      chronic and mental illnesses, and two had vision problems. The inclusion criteria for the
      study were agreement to participation in the study, age between 4 and 10 years, no vision or
      hearing problems, no history of surgical intervention, and no chronic and mental health
      problems. Children who met the inclusion criteria and who had written and verbal consents
      from their parents for participation in the study were divided into 2 groups. The
      experimental group consisted of 40 children who received a VR application, and the control
      group consisted of 38 children who received standard healthcare. A randomized block design
      method was used to randomize the participants to the groups. The randomization list was
      prepared by a third person and was given to the investigator only during the application.

      Instruments The data were collected using a participant information form to obtain details
      about baseline characteristics; children's fear scale (CFS) and children's anxiety meter
      scale (CAM-S) were used to evaluate fear and anxiety in children during both the pre- and
      postoperative periods, and the Wong-Baker faces pain rating scale (WBS) was used to evaluate
      the levels of postoperative pain in children. A white colored "VR BOX 3.0" with VR glasses (a
      headset with a screen covering the children's eyes) was used in this study. It was compatible
      with iOS and Android operating systems and 4-6-inch screen smartphones. The VR device, which
      is activated through applications installed on smartphones, divides the image into two equal
      windows, providing the necessary viewfinder range for panoramic view. The distance between
      the mobile phone and the lens can be adjusted for each user. The VR glasses do not require
      any power or electrical connection, except the mobile phone, during their use. The weight of
      the VR glasses is 0.414 kg. Soundproof headsets are used to provide immersive VR.

      Procedure Sociodemographic data of the children and their mothers were collected using the
      participant information form. Then, the children rated their fear and anxiety on the scales
      using a pen. Similar assessments were performed by their mothers and the investigator. The
      investigator explained the use of VR glasses to the children in the VR group. The
      investigator selected two VR programs to be watched by the children. In the VR program named
      Amazon, the child perceives himself to be walking among the trees in the Amazon forests. The
      other VR program gives the child a feeling of water skiing. Before commencement of the study,
      the VR applications were administered to five children aged between five and ten years, and
      these children shared no negative feedback about the VR programs. Before the surgery, the
      children were allowed to watch the VR program of their choice, the average duration of which
      was 4.5 minutes, using the VR glasses. Parts of the device that come in contact with the
      children's faces were cleaned before each application. After the surgery, the children, their
      mothers, and the investigator re-evaluated the fear and anxiety in children using the CFS and
      the CAM-S. The pain levels in children during the postoperative period were evaluated by both
      their mothers and the nurse. The same evaluations were performed in children in the control
      group who received routine clinical care.
    

Intervention name(s): Virtual Reality
Intervention type(s): Procedure
Intervention description(s): The investigator explained the use of VR glasses to the children in the VR group. The investigator selected two VR programs to be watched by the children. In the VR program named Amazon, the child perceives himself to be walking among the trees in the Amazon forests. The other VR program gives the child a feeling of water skiing. Before commencement of the study, the VR applications were administered to five children aged between five and ten years, and these children shared no negative feedback about the VR programs. Before the surgery, the children were allowed to watch the VR program of their choice, the average duration of which was 4.5 minutes, using the VR glasses. Parts of the device that come in contact with the children's faces were cleaned before each application
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This randomized controlled study was conducted a pediatric hospital in Turkey for circumcision between June and September 2019. The sample size for the study was calculated using the G-Power 3.0.10 program and t-test for comparison of two independent groups with an effect size of 0.8, an alpha level and margin of error of 0.05, and a power of 95%. The sample size was determined to be 70; each of the experimental and control groups included 35 children. Data were collected from 78 children. A randomized block design method was used to randomize the participants to the groups. The randomization list was prepared by a third person and was given to the investigator only during the application.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: circumcision; child; virtual reality; anxiety; fear; pain