Two Different Distraction Methods on Pain and Fear During Venipuncture in Children
Condition: Venipuncture Site Reaction; Procedural Complication; Nursing Caries
Study type: Interventional

Summary: 
      Objective: Needle-related procedures (venipuncture, vaccine injections) are the most common
      source of pain and fear, and generally experienced in childhood for the first time. This
      study was designed to determine the effects of watching cartoon films on non-VR and VR
      virtual reality on pain and fear during venipuncture in school-age children and to compare
      these two methods.

      Method: This randomized controlled trial study was conducted on 120 school-age children (7
      -12 years of age) with pain and fear of venipuncture. The children were randomized according
      to their arrival in the biochemistry laboratory; the first, second, and third children were
      assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet
      computer screen (n=40) and no distraction group (n=40), respectively. The data collection was
      carried out using the children identification form, Wong-Baker FACES Pain Rating Scale
      evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by
      the children, parent, and observer.
    

Detailed description: 
      Introduction: Needle procedures (eg, venipunctures, vaccine injections) are the most common
      and generally experienced in childhood for the first time. Children often describe needle
      procedures as the most painful and fearful intervention in the healthcare. The pain and fear
      of injections may affect the children psychologically and lead to situations such as refusal
      of interventions in children. Besides, these effects can disrupt the communication between
      nurses and children and cause distress to parents. Unmitigated pain during these procedures
      may increase fear which in turn can exacerbate future pain in an escalating relationship.
      However, there are no studies on the techniques applied to reduce pain and fear during
      venipuncture in school-age children, nor are there any comparing watching cartoon films and
      virtual reality. This study was carried out to determine the effects of watching cartoon
      films on non-VR and VR virtual reality on pain and fear during venipuncture in school-age
      children and to compare these two methods.

      Study design A randomized controlled clinical trial was conducted.

      The following hypotheses (H) were tested in this study:

      H1. Watching cartoon films by non-VR distractor to children during venipuncture would be
      effective in controlling pain and fear.

      H2. Watching cartoon films by VR distractor to children during venipuncture would be
      effective in controlling pain and fear.

      Sample and Setting This study was conducted with 120 children, studying at the at the
      Biochemical Laboratory of Medipol University Hospital, Turkey between September 2017-April
      2018. The sample included in the study were required to meet the eligibility criteria of
      being between 7-12 years old, a physician order was placed for blood sample, no current acute
      pain, no cognitive or severe physical disability, no communication difficult, blood sample
      was taken in the first attempt and consent of the parents for the child to take part in the
      research. The sample consisted of 120 out of the 147 children aged. Among the 27 children not
      included the sample group.

      Childrens were divided into 3 groups. The children were randomized according to their arrival
      in the biochemistry laboratory; the first, second, and third children were assigned VR group
      (n=40), non-VR group (n=40) and control group (n=40), respectively. The outcome measures were
      the level of pain and fear by the children, the parent and blinded research observer,
      immediately after venipuncture procedures.

      Data Collection Form Data collection was carried out using (a) the Children Identification
      Form prepared by the authors, (b) Wong-Baker FACES Pain Rating Scale and (c) Childrens' Fear
      Scale.

      Procedure The procedure and reason were explained to the child before each step of the
      venipuncture process such as apply a tourniquet, insert and remove the needle. The parent
      stopped on the left side of the child's in all groups. The display was a head-mounted VR box
      in the VR group. The computer tablet was the 10 centimeters far from the child in the non-VR
      group.
    

Intervention name(s): Virtual Reality Box; Tablet Computer
Intervention type(s): Device; Device
Intervention description(s): Virtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N.; The tablet computer is a device that children watch on a 7-inch screen.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This randomized controlled trial study was conducted on 120 school-age children (7 -12 years of age) with pain and fear of venipuncture. The children were randomized according to their arrival in the biochemistry laboratory; the first, second, and third children were assigned VR distraction group with a headset (n=40), non-VR distraction group on a tablet computer screen (n=40) and no distraction group (n=40), respectively. The data collection was carried out using the children identification form, Wong-Baker FACES Pain Rating Scale evaluating the pain and Childrens' Fear Scale evaluating the fear. The outcomes reported by the children, parent, and observer.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School-age children; pain; fear; venipuncture; distraction