Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Paediatric immunization is often associated with significant fear and anxiety among children
      and their parents. Their distress can greatly affect their future adherence to the
      immunization schedule and the acceptance of recommended vaccines by physicians. This pilot
      was a single-centre, open label, randomised controlled trial to examine the use of VR
      analgesia in childhood immunization in primary care.The study primarily aimed to determine
      the feasibility of using immersive virtual reality (VR) during immunization in children by
      assessing the response rate of the participants during recruitment. The secondary outcome of
      the study was to determine the effectiveness of immersive VR in alleviating pain and anxiety
      among children during immunization compared to usual care without VR. It also aimed to
      determine the effectiveness of immersive VR in reducing anxiety among the parents and nurses
      during immunization procedure.
    

Detailed description: 
      This study primarily aimed to determine the feasibility of using immersive VR during
      immunization in children. The response rate of the recruitment was the feasibility assessment
      on whether children and parents were acceptable to the VR usage during immunization. The
      secondary outcome mainly focused on the clinical and safety outcomes of using immersive VR
      during immunization in preparation towards a larger randomized control trial. The secondary
      outcome of the study was the change in children's pain and anxiety scores using the Faces
      Pain Scale-Revised (FPS-R) and Children's Fear Scale (CFS) pre- and post-immunization. The
      other secondary outcome were the change in parent's and nurse's anxiety score using the
      Anxiety visual analogue scale (VAS).The nurses' acceptability, simplicity and willingness to
      use VR during immunization were also assessed in the study. Adverse events such as premature
      termination due to VR side effects in the children were also reported.

      This pilot was a single-centre, open label, randomised controlled trial that was
      conceptualized as a proof of concept study to examine the use of VR analgesia in childhood
      immunization in primary care.

      Study Setting and Population:

      This study was conducted at a regional public primary care clinic (polyclinic) in Sengkang,
      which serves a population of about 240,000 inhabitants - of which children under the age of 9
      years old account for 14.5% of them (second highest paediatric population in Singapore).The
      study populations included multi-ethnic Asian children aged 4 to 10 years, their parents and
      the registered nurses who administered their immunization at the polyclinic.

      Sample Size:

      Julious SA recommends a sample size of 12 per group as a rule of thumb for a pilot study. We
      recruited 30 children for this pilot study, with 15 in the intervention group (VR) and 15 in
      the control group to allow for estimated 3 children who may fail to use the VR during the
      immunization for whatever reasons.

      Randomization:

      Randomization was performed a-priori using a computer generated randomization system. The
      randomization sequences were concealed in a numbered, opaque envelope. Blinding of the
      subject was not possible in this study due to the nature of the intervention. After obtaining
      the consent and assent, the study team member retrieved the randomization envelopes to reveal
      the group assigned to the child.

      Instrument to assess feasibility outcome:

      The response rate of the recruitment of children and parents on this study was assessed.

      Instruments to assess clinical outcome:

      There are various self-reported measurement tools for pain assessment in children. We
      selected the FPS-R scale which is a validated and well-established psychometric test,
      recommended by various literature and International Association for the Study of Pain (IASP).
      FPS-R has strong positive correlations with the visual analogue scale (VAS) across the age of
      4-16 years old.To date, there is no gold standard self-reported tools to measure children's
      anxiety during a needle procedure. We used the Children's Fear Scale (CFS) which was adapted
      from Faces Anxiety Scale that originally used in adult. Support was found for construct
      validity, test-retest reliability and inter-rater reliability for CFS during needle procedure
      among children. Anxiety VAS was used to assess anxiety in parents and nurses. The nurses'
      acceptability, simplicity and willingness to use VR during immunization were also assessed in
      the study, using a scale of 1 to 10.

      VR equipment:

      The VR equipment comprises an Oculus Quest headset (Facebook Technologies) which measures 8.7
      x 7.6 x 4.1 inches and weighs 0.57kg. The field of angle is 100° with adjustable
      inter-pupil-distance (IPD) ranging from 58 to 72mm. The VR headset has an adjustable strap
      which can fit various head sizes.

      VR software:

      Evidence suggests that if the VR environment is individually tailored to user's age, gender,
      ethnicity, the VR analgesic effect will be enhanced. The VR software named SILVER (Soothing
      Immunization Leveraging on Virtual Reality Experience) was co-created by the two
      investigators with software engineers and virtual artist team from Yoozoo Games Co., Ltd in
      Singapore.

      Recruitment procedure:

      The clinical research coordinator (CRC) screened the appointment list of eligible children
      scheduled for their influenza or other childhood immunizations at the study site. When the
      child turned up for their immunization appointment, the CRC provided the parent or legal
      guardian with the study information and clarified their doubts before seeking their consent.
      They also spoke to the child on the potential use of the gadget used in the VR to seek their
      assent.

      Written informed consent from the parent or legal guardian and assent from children were
      obtained prior to their study enrolment. The registered nurses involved also endorsed their
      consent to participate in the study. The study was conducted from September to December 2020.

      Pre-intervention procedure:

      The children in both groups rated their anticipatory pain score using the FPS-R scale and
      their anticipatory anxiety score using CFS. Their parents and respective attending nurses
      rated their anticipatory anxiety level using the Anxiety VAS before the immunization. The
      immunization room is cleared of any audio-visual equipment as a distraction in immunization.

      Intervention group:

      After revealing the allocation, the children allocated to the intervention group were briefed
      on the cartoon animation before they don the head-set. After the children entered the
      immunization room, the attending nurses completed their pre-procedure anxiety level using
      Anxiety VAS. The children donned the VR headset and viewed the VR animation. The animation
      can be viewed by the attending nurse via a tablet. At a specific juncture during the VR
      animation, the nurse administered the vaccine to the child. The duration of the storyline is
      about 2 minutes. At the end of each immunization, the VR headset will be cleaned and
      sanitized with standard infection control procedure in our institution.

      Control group:

      The children in control group underwent immunization as per usual care following our
      institution standard operating protocol. The nurse explained the immunization procedure to
      parents and children before the administration of the vaccine. The children in control group
      were not forbidden to use any distractions during immunization. Parents or additional nurses
      might be instructed to hold the child during the immunization procedure depending on the
      children's anxiety level to ensure accurate administration of the vaccine.

      Statistical analysis:

      All analyses were performed using IBM SPSS version 25.0. Both Intention to treat (ITT) and
      Per Protocol (PP) analysis were performed. Mann-Whitney U test was used to assess the
      difference in the change in anxiety and pain score in children, change in nurse's anxiety
      assessment and change in parent's anxiety assessment. Chi-square test and Fisher's exact test
      were used to assess the difference in the demographics of the two groups. Wilcoxon signed
      rank test was used to assess the difference in the nurses' experience of using the VR
      application. A p-value of less than 0.05 is considered statistically significant.
    

Intervention name(s): Virtual Reality Headset
Intervention type(s): Device
Intervention description(s): Virtual Reality Headset running SILVER software
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: virtual reality; pain; anxiety; children; immunization