The Effect of Virtual Reality On Pain and Anxiety During Blood Draw in Children: A Randomized Controlled Study
Condition: Pain, Procedural; Children, Only
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      Purpose: The study was carried out to determine the effect of virtual reality applied during
      blood collection upon pain and anxiety in children aged 5-12.

      Design and Methods: In this randomized controlled study, children included in the sample
      group were assigned to the control group (n=43) and Aquarium VR group (n=45) using block
      randomization. "Child State Anxiety Scale " and "Wong-Baker Faces Pain Scale" were used to
      collect the data of the study. Children in the Aquarium VR group watched the "Aquarium VR"
      application through virtual reality glasses during the procedure. The children in the control
      group benefited from routine nursing services. The pain scores after blood collection and
      anxiety scores before and during blood collection in children in both groups were
      interpreted.
    

Detailed description: 
      Purpose: The study was carried out to determine the effect of virtual reality applied during
      blood collection upon pain and anxiety in children aged 5-12.

      MATERIAL AND METHOD Study Design, Participants This study in randomized controlled design was
      carried out with children aged between 5-12 in Pediatric Polyclinic blood draw unit of the
      University Hospital in a province in Turkey between 15 May and 31 July 2021. The study
      population included children who applied to the Pediatrics Polyclinic blood draw unit of the
      prespecified hospital between 15 May-31 July 2021. It was calculated by taking into account
      the pre-test anxiety score averages of the intervention and control groups in the study of
      Gerker et al. (2019) (for the t-test to compare the two groups). As a result of the
      evaluations, it was calculated as d=0.99 (high effect size), power=0.95, α=0.05 in the
      G*Power 3.1.9.2 statistical program. Accordingly, it was determined that the minimum number
      of children to be included in the study was 28 for the intervention group and 28 for the
      control group, a total of 56 children. Between these dates, 45 patients were included in the
      experimental group and 43 patients in the control group, who met the research criteria and
      volunteered to participate in the research, and the study was completed with a total of 88
      patients. The study was carried out with children aged 5-12 years, who did not have
      communication barriers, did not use glasses, did not have pain before the procedure and did
      not have a chronic disease that would cause pain, blood was taken from the antecubital region
      and volunteered to participate in the study.

      Randomization The children were included in groups randomly. "Stratification and block
      randomization methods" were used in the study for assigning the participants to the control
      and study groups. It was reported in the literature that the variables of age, gender, and
      interventional procedure experience were among the factors affecting the pain and anxiety
      experienced by children during interventional procedures. In this sense, the children were
      stratified as "female and male" for the gender variable and "5-8 years and 9-12 years" for
      the age variable, and block randomization was performed. In order to prevent the groups from
      being influenced by each other, data of the study group were collected in one day and the
      control group in the other. Data collection days of the study and control groups were
      determined with the method of drawing lots. This cycle was continued until sufficient sample
      size was obtained.

      Data Collection Tools Question Form In this section, there were 6 questions related to the
      descriptive characteristics of the children (age, gender, education level of the mother,
      education level of the father, time of the last blood draw, the parent's presence with the
      child during the blood draw process).

      Wong Baker Faces Pain Scale-WBFPS This scale measuring the severity of pain was used in
      children aged between 3-18 years. In this scale, pain was scored for facial expressions
      according to numerical values, and the numerical rating of the scale varied between 0 and 10.
      Facial expressions ranging from smiling (0=very happy/no pain) to crying (10=most painful)
      indicated emotions. The severity of pain increased as the score obtained from the scale
      increased, and the severity decreased as the score decreased. The child was possible to tell
      the nurse about the pain experienced more accurately with the drawing illustrating what each
      of the different numbers on the pain scale indicated. This scale was a reliable measurement
      tool for the Turkish population (Tsao and Zeltzer, 2008).

      Children's State Anxiety Scale (CSAS) CSAS was a thermometer-like scale with a light bulb at
      the bottom and horizontal upward lines at intervals. On the scale, the children were
      instructed as "Imagine all your anxious or frustrated feelings are in the bulb or bottom of
      the thermometer." "If you're a little worried or nervous, emotions can go a little upward on
      the thermometer. If you are very, very anxious or nervous, the emotions can go to the top.
      Put a line indicating how worried or angry you are on the thermometer." In order to measure
      state anxiety (CSAS), the children were asked to mark what they felt "right now". Before
      filling in CSAS, sequencing skills of the children were monitored. They were asked to count
      to ten, They were also asked to answer, "Which is bigger, seven or four?" The children who
      could not successfully complete these tasks or did not understand the instructions were not
      asked to fill in CSAS. Subsequent to data collection, two members of the research team
      reviewed and scored CSAS of the children. A transparent meter with increments of ½ point
      marked was placed above the rating of children, then the increment of ½ point was rounded to
      the nearest number. The score varied between 0 and 10 (Gerçeker et al., 2018).

      Virtual Reality Headset In the Aquarium VR group, virtual reality headset compatible with
      iPhone 7 (Apple) was used to distract attention. Before use, the headsets were tested on five
      children for face fit and visibility of the application used. Written and verbal consent of
      the children and their parents was obtained to test the headsets. The children who tested the
      headsets were not included into the study. The headset offered a soft and comfortable
      experience in contact with the skin due to its leather and pad covering. It also had a wide
      viewing angle and an optical zoom button. Due to its noise isolation function, it did not
      disturb anyone or make noise.

      "Aquarium VR" Application The application simulated a submarine journey to explore the inside
      of virtual aquarium. The aquarium included sharks, aquatic mammals, clown fish and much more.
      It also allowed children to learn more about marine life in the Pacific Ocean (Eon Reality,
      2021).

      Ethical Principles of the Research In order to carry out the research, 14/03/2021 dated and
      03/14 numbered ethics committee approval from the Human Research Ethics Committee and legal
      permissions from the Hospital Management were obtained. After informing the children
      participating in the study and their parents about the research, they were explained about
      being free to participate in or not, and their written and verbal consent was also obtained
      from the parents. The children who participated into the study and their parents were assured
      that their personal information would not be disclosed to others, would not be used anywhere
      else and they had right to withdraw from the study at any time they wanted.

      Data Collection The children included into the study and control groups and their families
      were primarily informed about the study by the researcher in the waiting room at the entrance
      of the pediatric outpatient clinic blood draw unit. The children who were in 5-12 age group,
      had no communication barriers, did not use glasses, had no pain before the procedure and did
      not have a chronic disease causing pain, and volunteered to participate into the study were
      included in the study. The "Informed Consent Form" was signed by the parents and children who
      met the criteria and agreed to participate into the study. The children were stratified as
      "female and male" for the gender variable and "5-8 years and 9-12 years" for the age
      variable, and block randomization was performed.

      The children included into the study and control groups and their parents were asked to rate
      CSAS to assess their anxiety levels before and during blood draw, and WBFPS to determine the
      pain they felt in their arm during blood draw. Similarly, the nurse and researcher rated
      WBFPS and CSAS.

      The children in the study group were shortly informed about using the virtual reality glasses
      before the procedure. When the children sat on the patient's chair for blood draw, they put
      on virtual reality glasses and 3D "Aquarium VR" application was started to be watched from
      the virtual reality glasses 1 minute before the blood draw procedure. At the same time, the
      nurse applied a tourniquet for blood draw from the child and determined the vein from which
      blood would be drawn from the antecubital region. The blood was drawn from the antecubital
      region by the same nurse by means of a vacuum blood draw tube and the process lasted for
      approximately 2-3 minutes. During this procedure, the children were asked not to remove their
      virtual reality glasses at all.

      No interventional procedure was administered to the children in the control group. Blood was
      drawn from the antecubital region by the same nurse by means of a vacutainer. In both groups,
      parents were permitted to be with their children in the blood draw room during the procedure.

      Data Analysis and Interpretation SPSS 25.0 package software was used for statistical analysis
      of the data. Percentage, average, Simple t-test and One Way ANOVA analysis were used to
      interpret the data. The statistical level of significance was regarded to be 0.05 in all
      tests. In order to obtain statistical results, fit of the data to the normal distribution was
      interpreted using the Shao method. In this sense, the Skewness value was determined to be
      0.139, the Kurtosis value was -2,027, and it was found to have a normal distribution between
      -3 and +3.
    

Intervention name(s): Nanpharmacological method
Intervention type(s): Other
Intervention description(s): Virtual Reality
Intervention model: Single Group Assignment
Intervention model description: It is a randomized controlled trial consisting of an experiment and a control group.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety; Blood draw; Children; Nursing; Pain; Virtual reality