Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear
Condition: Pain; Fear
Study type: Interventional

Summary: 
      This experimental, prospective, and randomized controlled study was designed to determine and
      compare the effects of applying manual pressure and ShotBlocker methods in reducing pain and
      fear during the subcutaneous insulin injection for children with Type 1 diabetes mellitus. A
      parallel trial design was used describing two intervention (manual pressure and ShotBlocker)
      and a control group (no intervention used) as the third arm. The study population consisted
      of children aged 6-12 years, diagnosed with Type 1 diabetes mellitus, administered insulin
      injections, able to cognitively score their pain and fear levels, who wanted to participate
      in the study, and gave verbal and written consent to participate in the study.The study
      sample composed of 90 children based on confidence interval of 95% and statistical power of
      80%. Each intervention and control group was matched in terms of gender. In the study, the
      randomization of the sample group was performed by using stratification and block
      randomization methods.
    

Detailed description: 
      This experimental, prospective, and randomized controlled study was designed to determine and
      compare the effects of applying manual pressure and ShotBlocker methods in reducing pain and
      fear during the subcutaneous insulin injection for children with Type 1 diabetes mellitus. A
      parallel trial design was used describing two intervention (manual pressure and ShotBlocker)
      and a control group (no intervention used) as the third arm. The study sample composed of 90
      children based on confidence interval of 95% and statistical power of 80%. In post-hoc
      analysis made using G power 3.1 software, the power of sample size including 90 children with
      α = .05 and effect size (w)= .31, was 1 - β = 0.87. Power of .80 or higher is indicative of
      an adequate sample size. In addition, in order to prevent bias and increase the validity of
      the data, the pain and fear scores of the children before and after the procedure were
      assessed by three different groups as children (n:90), their parents (n:90), and a researcher
      specialized in pediatric nursing (the first author; n:1), and the inter-observer agreement
      was examined. The parents meeting the following inclusion criteria were eligible for the
      participation: 1) being healthy in terms of neurological functions, 2) communicating
      verbally, 3) understanding and reading Turkish, and 4) voluntarily signing the written
      informed consent. The children were first categorized according to their genders and then
      assigned into three study groups by using block randomization method to control the effect of
      gender on pain. First, the numbers 1, 2 and 3, representing the three groups, were written on
      paper of the same color and shape and put in a pink box for girls and blue for boys.After,
      female children were asked to draw a piece of paper from the pink box and male children were
      asked to draw a piece of paper from the blue box to provide a randomized distribution and to
      reduce all negative effects. Thus, the groups became self-balanced. Intervention and control
      groups were matched in themselves based on gender, each group included a total of 30 children
      including 15 girls and 15 boys. The study was conducted in accordance with the CONSORT
      guideline for reporting the randomized controlled trials.
    

Intervention name(s): Manuel pressure; ShotBlocker; Control
Intervention type(s): Other; Other; Other
Intervention description(s): 10-second manual pressure was applied on the insulin injection area.; ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.; No intervention was performed to reduce pain and fear.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Interventional
Masking: None (Open Label)
Primary purpose: Prevention