Evaluation of Virtual Reality Glasses Use During Inhaler Treatment in Children
Condition: Bronchiolitis; Anxiety
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      Virtual reality (VR) glasses are technological devices that are often used in medical fields
      recently and are seen as suitable for distracting children. In the last few years, many
      studies have been conducted to facilitate pediatric patients against painful or frightening
      medical procedures. For uncomfortable procedures, distracting the child's attention is seen
      as the most important point. VR technology has been used for procedures such as burn cases,
      tooth extraction, intramuscular injection, intravenous cannula, lumbar puncture, and the
      results of the research have been found to be satisfactory. Using VR glasses alone or in
      combination with standard care is effective in reducing pain and anxiety. So far, there is no
      study in the literature on distraction with VR during inhaler treatment in pediatric
      patients. Children cannot receive inhaler treatment efficiently due to reasons such as
      restlessness, crying, and pulling the mask during inhaler treatment, and their hospital stay
      is prolonged. In this study, the investigators planned to compare the patients who received
      inhaler treatment with VR glasses with the patients who received treatment without the aid of
      any device in terms of treatment compliance.

      Thus, the investigators aimed to make the inhaler treatment more comfortable with VR
      technology.
    

Detailed description: 
      The study was designed by including children aged 2-5 years, who needed inhaler treatment
      (salbutamol) between 10.11.2022 and 01.04.2023, whose families gave consent for the study.
      This age group (preschool) was chosen because it is the age group that presents the most
      difficulties to families and physicians during inhaler treatment and screen exposure does not
      cause problems up to a certain point. The study was conducted as a prospective, single-blind,
      randomized, controlled study in the Pediatric Emergency Department of the Health Sciences
      University Haseki Training and Research Hospital.

      Children with neuromotor retardation, visual and auditory problems, underlying chronic
      diseases (bronchiolitis, chronic lung diseases other than asthma, congenital heart diseases,
      neurological diseases such as epilepsy), obesity or malnutrition (to equalize the
      effectiveness of the drug dose), adrenaline, budesonide or Those who receive ipratropium
      bromide treatment, those who will receive inhaler nebula treatment for the first time, those
      who have received inhaler treatment in the last 72 hours, those who have a previous operation
      or sedative history, those who have a fever above 37.5°C, those who have used VR before,
      those under 2 years of age to avoid screen exposure children (infants) and children over 5
      years old (school period) were excluded from the study. In addition, children with a
      saturation value below 92% at the time of admission, those presenting with severe asthma
      attacks and those with respiratory failure symptoms were not included in the study. Children
      with a score of 5 and above according to the bronchiolitis severity score were excluded from
      the study.

      The children included in the study were divided into 3 groups by randomization method: VR
      audio-visual users (Roller Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2)
      and those who did not use any additional equipment. (group 3). These children were observed
      during their 15-minute inhaler treatment and the groups were compared in terms of crying
      times, changes in RR, SpO2, HR values with pre- and post-treatment physician questionnaires
      and family questionnaires.

      In the comparison study of Gerceker et al., with VR glasses in children from whom blood was
      drawn, the pain score was found to be 1.2 ± 2.2 in children using VR glasses, and 4.1 ± 3.5
      in children without VR (control group), and the standard effect size was determined as 0.99
      in the power analysis based on these data. When the number of 45 cases in each group is
      taken, the power of the study was calculated to be with a 1% margin of error and 98% power.

      During the study period (November 2022 - April 2023), 913 children received inhaler treatment
      in our hospital. Children who met the selection criteria and whose families agreed to
      participate in the study were included in the study, and the study was terminated when the
      target number of 135 children was reached. 689 children who did not meet the inclusion
      criteria (such as chronic disease or severe bronchiolitis) and were not suitable for their
      age (such as under 2 years old, over 5 years old) were excluded from the study. Of the 224
      children who met the inclusion criteria, 89 were excluded because they refused to participate
      in the study.

      The children to be included in the study were determined by randomization method. For
      randomization, the site named randomizer.org was used to randomize 3 different groups. A
      computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR
      glasses wild dolphins, and control). Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1
      Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then
      randomly placed in a blocking box. protected. Only the second researcher knew the group value
      of the sets.

      The children included in the study were divided into 3 groups: VR audio-visual users (Roller
      Coasters, group 1), VR audio-visual users (Wild Dolphins, group 2), and those who did not use
      any additional equipment (group 3). 3D Roller Coasters and 3D Wild Dolphins videos were used
      as VR images via Youtube application (Google LLC. California, USA; Youtube®). VR glasses were
      integrated into the tablet and given to the accompanying parent, so that the parent could see
      what their child was watching at that moment.

      Children in all groups were given 'salbutamol' inhaler treatment for 15 minutes, and equality
      was achieved between the groups in terms of treatment active substance and duration.
      Salbutamol was given to each child as 2.5 mg/2.5 ml. The children were observed during their
      15-minute inhaler treatment, and the crying times were compared with the anxiety scoring made
      by the same doctor before and after the treatment, and the minute respiratory rate (RR),
      oxygen saturation (SpO2), heart rate change (HR) and the duration of inhaler treatment were
      compared. In addition, families filled out questionnaires about their children's mental state
      before and after the treatment. The FLACC (Face, Legs, Activity, Cry, consolability) Pain
      Assessment Scale was used for the anxiety scoring made by the physician, and the Yale
      Modified Anxiety Scale (MYPAS), which was thought to be appropriate for our study, although
      it was designed to measure pre-operative anxiety. For families, a form consisting of eight
      'yes-no' questions called the Parents' Pain Measure (MPPM), modified by us and normally used
      for post-operative anxiety/pain measurement, was used. In addition, Wong Baker Faces Pain
      Rating Scale (WBS) was also used to evaluate the anxiety of the children for convenience to
      the family.

      The children to be included in the study were determined by a single researcher. The first
      investigator identified the children who met the inclusion criteria, noted the FLACC and
      MYPAS score, as well as the RR, SpO2, and HR values, and referred the child to the other
      investigator. The second investigator divided the child into his group using the
      randomization method, and determined the duration of crying and effective treatment, along
      with the duration of treatment, with a double chronometer during treatment. At the end of the
      treatment, the family and the child were re-directed to the first researcher on the condition
      that they did not tell the first researcher which group they were in. Thus, it was ensured
      that the first investigator did not know which group the child belonged to while filling in
      the FLACC and MYPAS score before and after the treatment and determining SpO2, RR and HR. In
      addition, with the MPPM and WBS performed by the families, the changes in the children's
      discomfort/restlessness were determined from the family's point of view before and after the
      treatment.

      Newly opened sterile masks were used for inhalation therapy in each child. In order to
      standardize the treatment, the 'Omron® CompAIR Pro NE-C900 Compressor Nebulizer' was used as
      a nebulizer. After each child, the infected materials of the VR glasses were removed with a
      surface disinfectant containing didecyldimethylammonium chloride and left in a disinfectant
      containing non-abrasive quarter ammonium carbonate, non-ionic surface active material and
      enzymatic complex, then rinsed with distilled water and waited until dry.
    

Intervention name(s): Virtual Reality audio and visual glass (Roller Coasters, group 1); Virtual Reality audio and visual glass (Wild Dolphins, group 2)
Intervention type(s): Device; Device
Intervention description(s): During the inhaler treatment, the child was shown Roller Coasters with VR glasses.; During the inhaler treatment, the child was shown Wild Dolphins with VR glasses.
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The children randomize 3 different groups. A computer-generated block method divided children into 3 groups (VR glasses roller coaster, VR glasses wild dolphins, and control).
Based on 45 randomly sorted sets (1, 2, 3) (eg Set 1 Group 2, Set 2 Group 3, Set 3 Group 1), a total of 135 unique codes were generated and then randomly placed in a blocking box. protected. Only the second researcher knew the group value of the sets.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Inhaler treatment; Children; Virtual reality glasses