Virtual-Reality and Cold-Vibration Device on Procedure-Related Fear, Anxiety and Pain During Pediatric IV Line Placement
Condition: Pain; Fear; Anxiety; Child, Only
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      Studies evaluating VR are quite insufficient. In the study we determined in the emergency
      room between the ages of 4-10, cold vibration and virtual reality will be compared, and the
      success of the first attempt, pain, fear and anxiety will be evaluated.
    

Detailed description: 
      It was planned to evaluate the effect of virtual reality, cold vibration device application
      on the first attempt success, procedure-related pain, fear and anxiety during pediatric
      intravenous line placement in children aged 4-10 years in the pediatric emergency unit.

      H1: Patients who watch videos with virtual reality glasses or who are applied cold vibration
      device during the vascular access procedure have a high first-attempt success.

      H2: The pain, fear, and anxiety scores of the patients who watch videos with virtual reality
      glasses or who are applied cold vibration device during the venipuncture procedure are lower.

      It is planned to include children between the ages of 4 and 10 who will be given vascular
      access in the Dokuz Eylül University Pediatric Emergency Unit. Between December 2020 and
      January 2021, it is planned to include patients selected by stratified randomization method
      in accordance with the sampling criteria. In the Gpower statistical program, based on the
      results of one-way variance analysis used in the comparison of pain and anxiety scores in the
      study of Canbulat et al. It was determined that a sample was required. In the study, it was
      planned to fulfill the parametric test assumptions and to have 50 children for each group and
      150 children for the total sample, considering 10% loss.

      Inclusion / exclusion criteria in the study:

        -  Children between the ages of 4-10

        -  The child agrees to voluntarily participate in the study.

        -  Parents agree to voluntarily participate in the study

        -  Obtaining consent form from the child and parent

        -  The child does not have a physical and psychological deficit to prevent him from wearing
           the glasses to be worn on his head so that he can watch virtual reality.

      Patients who will be peripheral IV line accessed will be allocated to the groups according to
      randomization. The child and parents will be informed and after their consent, the group they
      belong to will be determined. No additional intervention will be made to the patient in the
      control group and will be observed during the procedure after obtaining her consent.

      Standard approach will be applied to all pediatric patients. Standard approach; Providing
      information about the procedure, introducing the nurse himself, choosing the region together,
      being with the parent and talking to the child during the procedure. No additional
      intervention will be made to the patient in the control group, and until the intervention
      begins, "How old are you? Which grade are you in? What is the name of your favorite friend?
      Which sport do you like better? " Attention will be distracted by asking questions such as.

      By introducing a virtual headset to the selected child to the video monitoring initiative
      group with virtual glasses, it will be said that he can watch videos by wearing the virtual
      headset during the procedure (Figure 1). The video he wants to watch together will be
      determined. If virtual glasses are desired to be removed during the procedure, the child will
      be excluded from the study. One of the 3 interesting videos will be determined by the
      researchers, with the preference of the child.

      In the cold vibration group, bee Buzzy will be attached to the arm where the nurse will
      perform the peripheral IV line access. Bee Buzzy confuses nerves and reduces pain thanks to
      its cold wings and vibration. help distract attention during the injection period, reduce the
      feeling of pain and fear. Buzzy will be tied 5 cm above the area where blood will be taken,
      and after waiting 15 seconds, vascular access will be opened by the nurse. It will be wiped
      with disinfectant before and after the intervention.

      After each patient included in the study is taken to the chair where the intervention will be
      performed (the starting hour/minute of the procedure will be recorded), the patient will be
      monitored and pulse, respiration, and blood pressure will be measured. The child will be
      evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children.

      The patient's pulse, respiration, blood pressure will be measured again (minutes will be
      recorded). Pulse, respiration and blood pressure will be re-evaluated at the 5th minute of
      the beginning of the procedure. At the 5th minute of the procedure, the child will be asked
      to evaluate the most painful moment he feels during the procedure with a Facial Expressions
      Rating Scale and a Color Analog Scale. The child will be given the Child Fear Scale (CFS) and
      the Child Anxiety Scale-State to evaluate how anxious and afraid he or she is during the
      procedure. You will be asked to mark it with a pencil.

      Research data will be collected by the following data collection forms:

      Socio-Demographic Data Collection Form Procedure Follow-up Form Pain scale Fear Scale Child
      Anxiety Scale-State Emotional Appearance Scale for Children

      Socio-Demographic Data Collection Form: The Socio-demographic Data Collection Form consists
      of questions about the sociodemographic characteristics of the children and parents who will
      participate in the study. Sociodemographic features; It includes "age, gender, diagnosis,
      date of last bloodletting" regarding the child, and "age, closeness to the child, educational
      status, number of children" for the parent.

      Procedure Follow-up Form: The child's difficult vascular access intervention score, procedure
      initiation time, vital signs, and first attempt success will be recorded.

      Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to
      rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).

      The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures
      procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no
      fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear
      (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher
      scores mean a worse outcome. The rater response indicates the level of fear. It can be used
      during the procedure for children aged 5-10 years.

      The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's
      anxiety and uses before medical procedures. This scale is drawn like a thermometer with a
      bulb at the bottom and also includes horizontal lines at intervals going up to the top
      (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.

      Emotional Appearance Scale for Children: This scale allows direct behavioral observation,
      consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity',
      'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of
      behavior in each category and selecting the numerical value that most represents the observed
      behavior. Each category is scored from 1 to 5. The total score is made so that the numerical
      value is between 5-25 by adding the points obtained for each category. Higher scale score
      indicates the appearance of more negative emotional behaviors.
    

Intervention name(s): virtual reality; Cold vibration
Intervention type(s): Device; Device
Intervention description(s): wearing virtual reality glasses; Buzzy
Other intervention name(s): distraction methods; distraction methods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care