The Effect of Cold Spray and Ice Applied During Intravenous Access on Pain and Fear i in Pediatric Emergency Unit
Condition: Children, Only; Pain; Emergencies
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      Many strategies have been developed for the prevention of to prevent procedural pain in
      pediatric emergency units where nurses play a vital role in patient comfort.Easy-to-use and
      inexpensive nonpharmacologic analgesic methods are important in emergency units.This study
      was conducted to determine the effect of cold spray and ice applied during venipuncture on
      the level of fear and pain in children ages 7-15. This randomized, controlled experimental
      study was conducted in the Pediatric Emergency Clinic of Istanbul Gaziosmanpaşa Training and
      Research Hospital between November 2021 7 and April 2022. The study was conducted with 96
      children between the ages of 7 and 15 (cold spray group, ice group, and control group) who
      were scheduled to have venous access in the pediatric emergency clinic and met the sampling
      criteria.

      The Pediatric Emergency Clinic consists of 10 beds. Patients with complaints such as fever,
      vomiting, diarrhea, and seizures comprise the majority of those admitted to the clinic. In
      the Pediatric Emergency Clinic, intravenous interventions were performed in the injection
      room.
    

Detailed description: 
      This study aimed to determine the effect of cold spray and ice applied during venipuncture
      procedures on pain and fear in 67 children ages 7-15 admitted to the pediatric emergency
      unit.

      Materials and Methods Setting This randomized, controlled experimental study was conducted in
      the Pediatric Emergency Clinic of Istanbul Gaziosmanpaşa Training and Research Hospital
      between November 2021 7 and April 2022. The Pediatric Emergency Clinic consists of 10 beds.
      Patients with complaints such as fever, vomiting, diarrhea, and seizures comprise the
      majority of those admitted to the clinic. In the Pediatric Emergency Clinic, intravenous
      interventions were performed in the injection room.

      Sample The study's population comprised children ages 7-15 treated in the Pediatric Emergency
      Department of Gaziosmanpaşa Training and Research Hospital. The sample consisted of children
      undergoing intravenous access in line with the inclusion criteria. According to the power
      analysis for the sample size in line with the literatüre the power of the sample was
      calculated with the G*Power 3.1 program. With a Type I error of 0.05 and a test power of 0.80
      (α= 0.05, 1-β= 0.80), the minimum sample size was calculated as children (30 children in 83
      each group). The study was completed with 96 children, including 32 children in the study and
      control groups, taking into account the losses that might occur from the sample for any
      reason during the study period.

      Allocation In the study, 96 children in the sample will randomly assigned to the control
      (n=32), ice (n=32), and spray groups (n=32). Random assignment will ensured by using a
      computer program to determine the group of children
      (https://www.randomlists.com/team-generator).

      Data Collection Before starting the study, the families of the children were informed of the
      purpose, plan, duration, and how the data would be used. Written consent was obtained in
      light of the principle of willingness and voluntariness through the Voluntary Information and
      Consent Form. Pediatric patients included in the study were divided into three groups: cold
      spray, ice, and control. Environmental conditions were organized the same way in all three
      groups, and at least one parent was ensured to stay with each child. The study was conducted
      with a nurse performing intravenous intervention and a nurse researcher.

      IV Catheter placement IV placement was performed using 24-gauge catheters appropriate in size
      for the age of the children and took an average of 3 minutes. The observer nurse evaluated
      the children in all groups before and after the procedure by filling out the data collection
      form and measuring the child's pain and fear assessment scales. The pain and fear scales were
      also evaluated by the child and parent. In all groups, IV insertion was performed by the same
      nurse following the procedure steps.

        -  First study group: Before performing intravenous intervention, cold spray was applied
           for 5 seconds at a distance of 15 cm to an area of approximately 5 cm2 at the site of
           the procedure. After tourniquet fixation and subsequent skin disinfection for 60
           seconds, the nurse researcher performed intravenous administration.

        -  Second study group: Before the intravenous intervention, refrigerated gel ice was
           applied for 5 minutes at 2 cm above the area to be treated. After that, the nurse
           removed the gel ice from the procedure area, a tourniquet was applied, and skin
           disinfection was performed for 60 seconds. The nurse researcher performed intravenous
           administration.

        -  Control group: No pharmacologic or nonpharmacologic application was performed. The
           researcher performed intravenous access after skin disinfection by the nurse.

      ETHICAL CONSIDERATION Written permission were obtained from the ethics committee of
      Gaizosmanpaşa Training and Research Hospital to collect the data before the study (No: 347,
      Date: 20.10.2021). The rules of the Declaration of Helsinki were followed throughout the
      study. Verbal and written informed consent was obtained from the families of pediatric
      patients who agreed to participate in the study. After patients entered the pediatric
      emergency clinic in accordance with the sample selection criteria, the parents were explained
      the purpose of the research, that their personal information would remain confidential, and
      that their privacy would be respected.

      STATISTICAL ANALYSIS Statistical analyses were performed using R vers. 2.15.3 program
      Minimum, maximum, mean, standard deviation, median, first quartile, third quartile,
      frequency, and percentage were used to report the study data. The Shapiro-Wilk test and
      graphical analysis were used to evaluate the compliance of quantitative data with normal
      distribution. A dependent groups t-test was used to compare the values before and after the
      intervention. An independent groups t-test was used to evaluate normally distributed
      variables between two groups. One-way analysis of variance was used in the evaluations of
      variables with normal distribution between more than two groups. The Mann-Whitney U test
      evaluated variables that did not show normal distribution between the two groups. The
      Kruskal-Wallis test was used in the evaluations of variables that did not show normal
      distribution between more than two groups. Pearson correlation analysis was used to determine
      the relationship between quantitative variables. The Pearson chi-square test,
      Fisher-Freeman-Halton exact test, and Fisher's exact test were used to compare qualitative
      variables. Statistical significance was accepted as p<0.05.
    

Intervention name(s): Cold spray; Refrigerated gel ice
Intervention type(s): Other; Other
Intervention description(s): Cold spray was applied for 5 seconds at a distance of 15 cm to an area of approximately 5 cm2 at the site of the procedu; Refrigerated gel ice was applied for 5 minutes at 2 cm above the area to be treated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: ıce pack; cold spray; fear; pain