Intramuscular Injection-Related Pain and Fear
Condition: Pain; Fear
Study type: Interventional

Summary: 
      The study is an experimental randomized controlled study conducted to compare the effect of
      buzzy and shotblocker methods applied during intramuscular injection from on pain and fear
      level in 6-12 year-old children. The sample of the study consisted of 90 children aged
      between 6 and 12 years who were diagnosed with upper and lower tract respiratory infections
      and received intramuscular injection of ceftriaxone at the pediatric emergency department of
      a university hospital in İstanbul between November 2018 and April 2019. The children were
      divided into 3 groups of 30 people, including shotblocker, buzzy, and control groups. 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: 
      The study is a randomized controlled, non-blinded, experimental trial. The sample of the
      study consisted of 90 children aged between 6 and 12 years who were diagnosed with upper and
      lower tract respiratory infections and received intramuscular injection of ceftriaxone at the
      pediatric emergency department of a university hospital in İstanbul between November 2018 and
      April 2019. The children were recruited into the study on the basis of the following
      criteria: being aged between 6-12, requiring for ceftriaxone intramuscular injection because
      of upper and lower respiratory tract infections, being cognitively able to rate pain and fear
      scales, and voluntariliy signing the written informed consent. Children were excluded if they
      had a disease causing chronic pain, received analgesics within the last 6 hours, with
      pacemakers, had infection, rash, or detoriorated skin integrity in the site where the
      injection was to be made, had nerve damage in the injection site, had critical or unstable
      health status, had intellectual disability, reynaud's syndrome, and sickle cell disease, and
      were unwilling to participate in the study. Also, the parents were eligible for the
      participation when meeting the following inclusion criteria: 1) be healthy in terms of
      neurologic functions, 2) communicate verbally, 3) understand and read Turkish, and 4)
      voluntarily sign the written informed consent. The sample size should be determined as
      minimum 30 in both experimental and control groups in the experimental studies and parametric
      measurements. Therefore, 90 children who met the inclusion criteria of the study between
      specified dates were enrolled and each group included 30 children including two experimental
      groups and a control group. 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 participating in the study (n:90), their parents (n:90),
      and a researcher specialized in pediatric nursing (n:1).

      The children were included in one of the 3 study groups, including buzzy, shotblocker, and
      control group without any intervention. In order to control the effect of gender on pain, the
      children were stratified into study groups based on their gender and selected by using block
      randomization methods in three study groups. The children were randomized to the related
      study group by drawing one of the study groups in the cloth bags prepared for the girls
      (pink) and the boys (blue). Papers with the same color and folding pattern representing the
      four groups (1,2,3,4) were thrown in the bags. In order to provide a randomized distribution
      and to reduce all negative effects, the children were asked to take randomly a paper from the
      bag according to the gender after making the necessary explanation to the parents and their
      children so that the groups became self-balancing. A total of 30 children including 15 girls
      and 15 boys were included in each group after intervention and control groups were matched in
      themselves in terms of gender.

      The study followed the CONSORT guideline for reporting randomized controlled trials. The pain
      level of children before and after the injection was assessed using Wong-Baker FACES Pain
      Rating Scale. To assess the pain level of the children, the children were asked to evaluate
      themselves, and their parents and first researcher were requested to evaluate the children's
      pain level immediately before and after the injection. The responses of the children, their
      parents, and the first researcher were scored blindly. The fear level of children before and
      after the injection was assessed using Children's Fear Scale. To assess the fear level of the
      children, the children were asked to evaluate themselves, and their parents and first
      researcher were requested to evaluate the children's fear level immediately before and after
      the injection. The responses of the children, their parents, and the first researcher were
      scored blindly.
    

Intervention name(s): Shotblocker; Control; Buzzy
Intervention type(s): Device; Procedure; Device
Intervention description(s): Injection was administered with ShotBlocker.The Shotblocker application to all children in this group was done by the second researcher. After the injection, the shotblocker was wiped with 70% alcohol.; No intervention was made in the children.; Buzzy was placed 3-5 cm above the injection site 60 sec before the injection and used until the procedure was completed.The Buzzy application to all children in this group was done by the second researcher. After the injection, the ice pack was wiped with 70% alcohol and frozen again by freezing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pain management; intramuscular injection; non-pharmacological method