Nonpharmacological Methods for Children
Condition: Child; Procedural Anxiety; Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The study was designed as a randomized controlled experimental research with the purpose of
      determining the effect of the methods of cold application and Shotblocker on the pain and
      anxiety level of the children in reducing the pain associated with the intramuscular
      injection.

      The hypotheses of the study:

      Hypothesis 0. Shotblocker and the cold application to the injection site prior to the
      injection are not effective in reducing the pain associated with the intramuscular injection
      in children.

      Hypothesis 1. Using ShotBlocker during the intramuscular injection reduces the pain and
      anxiety experienced by the child.

      Hypothesis 2. Applying cold to the injection site prior to the intramuscular injection
      reduces the pain and anxiety experienced by the child.

      This research was designed as a randomized controlled experimental study in a university
      hospital in Çorum.

      The sample of the study comprised 150 children aged 7 to 12 years who were brought to the
      pediatric injection room in a university hospital and had intramuscular injection. The
      children were randomized into the Shotblocker (n=50), cold application (n=50) and control
      (n=50) groups. In addition to Wong-Baker Pain Scale and Child Anxiety Scale, the Child
      Information Form was used in the study to determine the introductory characteristics of the
      children and their family.
    

Detailed description: 
      The population of this study consisted of the children within the age range of 7-12 years who
      applied to the injection room in the pediatrics clinic of a university hospital between
      November 2017 and June 2018. On the other hand, the sample of this study consisted of 150
      children who met the case-selection criteria and agreed to participate in the study.

      In the Power analysis carried out based on the literature, the sample size of the study was
      determined as 150 with the confidence level of 90% (α=0.10). For 150 children, the power was
      β=0.20, 1-β=0.80 with α =.05. The approximate number of subjects was calculated as 50 per
      group with the Cohen's effect size of α = .05 and the confidence interval of 95%. The
      children in the sample were randomly assigned to the following groups: Cold application,
      Shotblocker, and control. In order to determine which case to include in which group, the
      numbers were randomly distributed to the 3 groups without repetition using a software. In the
      study, the sample size for each of the 3 groups, that is, cold application group (n=50),
      Shotblocker group (n=50), and control group (n=50) was determined as 50.

      The intramuscular injection was carried out in the pediatric injection room of a university
      hospital. Before the intervention, the parents and children were met, they were informed
      about the study, and they were asked whether they would accept to participate in the study.
      The written and verbal consent were obtained from the parents and the children, respectively.
      In order to ensure reliability in the study results, the intramuscular injection was applied
      by the same nurse having at least 5 years of working experience throughout the study; and the
      pain behavior and anxiety levels of the children were evaluated by the same researcher. The
      parents were allowed to stay with their children during the intramuscular injection.

      The following information was obtained from the children and parents who agreed to
      participate in the study using the Child Information Form: the socio-demographic
      characteristics of the children and parent, the previous history of IM injection, the
      previous history of being subject to a painful intervention, whether the child took an
      analgesic drug within the last 6 hours, the body mass index (BMI), etc. Prior to the
      intramuscular injection, the children's weight and height were measured and recorded. The
      same medicine (procaine penicilline) was administered to all children.

      During the intramuscular injection, it was ensured that the environmental factors
      (temperature, light, noise, etc.), the injection site, and the antiseptic solution (70%
      alcohol) were standardized. The injection site was wiped using an antiseptic
      (batticon/chlorhexidine) cotton by gently pressing from center to periphery. It was ensured
      that the child was in the appropriate position, that is, in the prone position, with the toes
      facing inward. Prior to the injection, Shotblocker or the cold gel pad was introduced to the
      children in the experimental group and they were informed of how they would be used.
      Furthermore, the children and parents were informed about the Wong-Baker FACES® Pain Rating
      Scale and Children's Fear Scale (CFS) to be used in the study. The parents and children who
      volunteered to take part in the study were informed of the scale scoring. Which parent would
      take part in the study was left to the choice of parents to take participate. The CFS scale
      was evaluated preoperatively after receiving consent from the children and parents and
      completing the information form. The pain evaluation was made by the children, parents, and
      observers right after the procedure. When applying the scales, a particular attention was
      paid so that the children, parents and observers would not see each other's evaluation and
      not affect one another. Before the injection, the anxiety level was evaluated by the child,
      parent, and researcher using Children's Fear Scale (CFS). After the injection; the pain level
      was evaluated by the child, parent, and researcher using the Wong-Baker FACES® Pain Rating
      Scale, and the anxiety level was evaluated by the parent and researcher using Children's Fear
      Scale (CFS).

      The data of the study was collected using the Child Information Form, the Wong-Baker FACES®
      Scale, and Children's Fear Scale.

      Child Information Form: This form was prepared by the researcher to get information about the
      children selected for the sample. This form contains a total of 12 questions such as
      socio-demographic characteristics of the children, whether the child has a health problem
      that affects her/his perception of pain, the previous history of IM injection, injection
      duration, and whether the child has injection fear, etc.

      Wong-Baker FACES® Scale (WB-FACES): In this scale, there are six faces representing the pain
      in an increasing order of intensity from zero to five from left to right. The leftmost face
      has a smile on it, representing "no pain"; whereas the rightmost face has a crying
      expression, representing "the most intense pain." As the score obtained from the scale
      increases, the pain tolerance decreases, and vice versa. In practice, the child is asked to
      choose the face that best expresses her/his feelings. In the application of the scale, it is
      explained to the child that each face belongs to a person, and the faces represent a happy
      person with no pain or a sad person feeling a little or too much pain.

      Children's Fear Scale (CFS): The scale is used to measure the levels of fear and anxiety in
      children. The child is shown a picture of 5 facial expressions, each having a score between
      "0" and "4" points. This scale can be easily applied by both researchers and families to
      measure the fear and anxiety before and during the applications. In the scale, while "0"
      refers to "no fear and anxiety"; "4" refers to "the highest fear and anxiety".

      The data obtained in this study was analyzed using IBM SPSS Statistics 22 (IBM SPSS, Turkey).
      The fitness of the parameters to normal distribution was evaluated by the Shapiro-Wilks test.
      In the evaluation of the data, in addition to the descriptive statistical methods (Mean,
      Standard deviation, Frequency), one-way analysis of variance (ANOVA) test was used for the
      comparisons of three or more groups with normal distribution and Tamhane's T2 for the paired
      comparisons. On the other hand, Chi-Square test was used for the comparison of the
      qualitative data. The statistical significance was set at p<0.05.

      Permission was obtained from the clinical research ethics committee (29.07.16 / 2016-41) to
      implement the study, and from the relevant institution to carry out the study. Before
      starting the research, all the children and parents were informed of the purpose of the
      study, how the study would be carried out, and how the data of the study would be used; and
      then their verbal and written consent were obtained through the Voluntary Informed Consent
      Form. Furthermore, they were informed that they could quit the study at any time without
      giving any reason.
    

Intervention name(s): Cold application group; Shotblocker group; Control Group
Intervention type(s): Other; Other; Other
Intervention description(s): Cold application group (Group 1): In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.; Shotblocker group (Group 2): The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.; Control Group (Group 3): The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized controlled trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cold application; Intramuscular injection; Pediatric nurse; Shotblocker