Effects of Virtual Reality on Pain, Fear and Anxiety During Blood Draw in Children Aged 5-12 Years Old
Condition: Pain; Anxiety State; Fear; Child, Only
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Virtual Reality (VR) has firmly stood amongst other technological devices and can easily be
      adapted to clinical procedures due to its low cost. It can be easily used particularly in
      pediatric care units because it appeals to various age groups and can be adapted to mobile
      phones. Virtual Reality (VR) can be used during painful procedures in children. The aim of
      this study was to evaluate the effects of two different VR methods on procedure-related pain,
      fear and anxiety of children aged 5-12 years old during blood draw. This randomized
      controlled study used parallel trial design.
    

Detailed description: 
      Aim and Hypothesis

      The aim of this study was to evaluate the effects of two different VR methods on
      procedure-related pain, fear and anxiety levels of children aged 5-12 years old during blood
      draw. The hypotheses of this study were to:

      H1: Children in the two different VR groups will have significantly less procedure-related
      pain than those in the control group.

      H2: Fear and anxiety scores of the children in the two different VR groups will be reduced
      than those in the control group.

      Study sample This prospective, randomized controlled study was conducted at a university
      hospital special blood draw unit in Izmir, Turkey between September 2017 and November 2017. A
      parallel trial design was used describing two different VR groups (VR-Rollercoaster group and
      VR-Ocean Rift group) and a control group (no VR device used) as the third arm. Children aged
      5-12-year-old who underwent blood draw were eligible to participate (n=136). This age group
      was selected because they were open to co-operation and more curious about technology.

      It was determined that 18 children in pain dimension and 19 children in fear dimension should
      be sampled in each group according to the one-way analysis of variance for the comparison of
      mean self-reported pain and fear scores (Canbulat et al., 2014), based on a power of .95 and
      an acceptable Type I error size of .05 in three groups in the Gpower 3.1.0 statistical
      program. It is planned that each group will consist of 45 children, considering that the
      parametric test assumptions can be fulfilled and lost in the study.

      Randomization One hundred seventy-three children were assessed for eligibility; 32 children
      were excluded; refused to participate (n = 18); had chronic or genetic diseases (n = 12); had
      visual problem (n = 2). One hundred forty-one children randomized; 5 children were
      excluded/incomplete data collection (wanted to remove VR during the procedure). The final
      sample comprised 136 children (Figure 1) (Schulz, Altman, Moher, & the CONSORT Group, 2010).

      The children meeting the inclusion criteria's were included in the study; (a) aged
      5-12-year-old, (b) underwent blood draw, (c) had no chronic or genetic diseases, (d) had no
      visual problem or eyeglasses. The informed consent was received form children and parents.
      Their sample characteristics recorded. They were allocated by the blocked randomization;
      gender (2 blocks) and age groups (5-8 / 9-12-year-old: 2 blocks). The allocation concealment
      was guaranteed by a computer-generated number table by the researcher. Children and parents
      did not know which group they were included at the time of allocation concealment.

      Instruments Demographic Form. This form included the child's gender, age, the last blood draw
      time, blood draw success and also the parent demographics such as age, educational level.

      Wong-Baker FACES (WB-FACES) Pain Rating Scale. This scale uses in children aged 3 and older
      to rate pain severity. This numeric rating scale ranges from 0 to 10.

      The Child Fear Scale (CFS). This scale is a one-item self-report measure for measuring
      pain-related fear in children. It ranges from a no fear (neutral) face on the far left to a
      face showing extreme fear on the far right. The rater responds indicates the level of fear
      for children aged 5-10 years (McMurtry, Noel, Chambers, & McGrath, 2011).

      The Children's Anxiety Meter (CAM). It assesses children's anxiety in clinical settings and
      uses before medical procedures. Children are asked to mark how he/she feel "right now" to
      measure state anxiety (CAM-S). (Kleiber & Mccarthy, 2006). Scores range from 0 to 10. It
      validated at children aged 4-10 years during an intravenous procedure.

      Data collection A single researcher (called Z) gave information about the study to the
      participants in the waiting area in the entrance of a private blood draw unit. The informed
      consent was received form children and parents. Their sample characteristics recorded. The
      allocation concealment was guaranteed by a computer-generated number table by the researcher
      Z. Children and parents did not know which group they were included at the time of allocation
      concealment. The researcher Z informed the researcher G that children allocated to which
      group.

      CFS and CAM-S were administered by another researcher (called D) to the children to assess
      their fear and anxiety levels about blood draw. The researcher D did not know which group
      children were included, was blinded to the groups. The children were told that their blood
      would be drawn, and that they would be asked to rate their fear and anxiety on CFS and CAM-S
      just before the blood draw. The instructions about the scales were read to the children.
      Children rated the score on the paper. Afterwards, the children's parent was asked to rate
      the CFS and CAM-S according to child's fear and anxiety. Child and parent were blind to each
      other score. Finally, the researcher D rated CFS and CAM-S. The researcher D was not blinded
      to the children and parent's score because she collected the scores. The children and their
      parents were taken into the unit where the blood draw was performed. All children were
      allowed to keep their family nearby during the blood draw.

      Blood draw procedure; It was performed 5 pediatric nurse specialists in this special blood
      draw unit. There were 5 blood collection cabins in the unit, the child went to the cabin
      according to the sequence number. Each blood draw cabin had one nurse. When the child went to
      the cabin, the nurse asked for the name of the child and told the child to sit in the blood
      draw chair. His/her parent also sat in a chair next to the child. The nurse introduced the
      materials to be used in the blood draw process, asked the child which arm wants blood drawn.
      After allowing the child to blood draw, the nurse performed the procedure. If the procedure
      failed, the child was asked to allow the blood draw from the other arm. If the child did not
      want to blood draw immediately, it was expected for a while. The nurse performed the
      procedure again when the child is ready.

      Scripted verbal protocol used for nurses. It was stated that children in the control group
      would not be administered a non-pharmacological method. The children in the VR groups were
      told to watch the video by wearing virtual glasses. However, it was not explained which VR
      group the child was. The nurses were blinded to the VR groups. They were told to stop the
      procedure if child wanted to remove the virtual glasses. The nurses were asked to rate the
      WB-FACES for all of the children after the blood draw. The nurses had no conﬂict of interest,
      all of them agreed to participate.

      Control Group; The first researcher (called G) explained to the patients in the control group
      that no additional procedure would be performed and they would be monitored during the
      procedure if their informed consent was received. Control group children did not receive any
      distraction techniques.

      The virtual headsets were introduced to the children in the intervention groups by the
      researcher G, and they were told that they could watch applications by wearing the virtual
      headset during the procedure. The VR applications were chosen by the researchers. Since fear
      and anxiety, as well as pain, were assessed in the present study, the researchers preferred
      one of the applications to be more remarkable/distractor and the other to be more relaxing.
      Before the study was conducted, 10 children aged between 5 and 12 years old were asked to
      watch these two applications, and no negative feedback was received. By wearing the VR
      headsets in the VR-Rollercoaster Group, individuals feel as if they are getting on and riding
      a rollercoaster. The rollercoaster speeds up and slows down. By wearing the VR headsets in
      the VR-Ocean Rift Group, individuals can take an underwater tour with 12 different marine
      animals with slow music.

      The children were excluded from the study that they wanted to take off the virtual headset
      during the procedure. When the child wanted to take off the virtual headset, blood draw
      procedure was stopped and immediately the virtual headset was removed and blood draw
      procedure continued.

      During the procedure, the researcher G monitored the children and recorded the procedure
      success at the same time. When the blood started to flow into the tube within 5 seconds with
      disposable Vacutainer®, the blood draw was considered successful.

      After the procedure finished, the researcher G, the children and their parents went to the
      waiting area in the entrance of a private blood draw unit. The researcher G gave the children
      a pen and asked them to rate the fear and anxiety they experienced during the blood draw
      procedure on the CFS and CAM-S again and also asked to rate their pain levels on the
      WB-FACES. Afterwards, their parents were asked to rate the CFS, CAM-S and WB-FACES. The
      researcher G also rated CFS, CAM-S and WB-FACES. After the children left from the unit, the
      nurse who performed the procedure was asked to rate the WB-FACES. The nurse was blinded to
      the child, parent and researcher's score. The researcher G was not blinded because she
      collected the scores. The researcher G and researcher D were blinded to each other's scores.
      The researcher G didn't know the scores before the blood draw.

      Ethics Ethical approval was received from the Non-Invasive Clinical Studies Ethics Committee
      of University (3481GOA 2017/20-02) and institutional permissions (71995408-000-10575). The
      researcher informed the children and their parents about the aim of the study and obtained
      written consent forms from parents.

      Data Analysis Data analysis was conducted by the Researcher M, was blinded to the groups.
      Percentages and means were used to evaluate the sample demographics. The data were analyzed
      using SPSS (22.0) software. The normal distribution of the data was assessed by
      Kolmogorov-Smirnov and Shapiro-Wilk tests. Sample characteristics were compared with Chi
      Square test in the three groups. The pain scores of the different VR and control groups were
      not normally distributed, the comparison of the pain scores of the three groups were
      evaluated with Kruskal Wallis analysis. One-way ANOVA test was used to compare the mean
      scores of the groups because of the normal distribution of fear and anxiety scores of the
      three groups before and after the blood draw. For any statistically significant differences
      between the three groups, post hoc pairwise comparisons were conducted using the Bonferroni
      adjustment. The effect of three groups on predicting fear and anxiety, and the effect of
      decrease in fear and anxiety were evaluated with linear regression analysis. The data were
      analyzed by using Tolerance and VIF values. p values were accepted as statistically
      significant <.05.
    

Intervention name(s): Children watch applications by wearing the virtual headset during the blood draw.
Intervention type(s): Behavioral
Intervention description(s): wearing the virtual headset
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, parallel trial design
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: blood draw