THE EFFECT OF STRESS BALL DURING THE PROCEDURE IN CHILDREN
Condition: Having a Blood Draw
Study type: Interventional

Summary: 
      This research was planned in a Randomized Controlled Experimental Research design with
      Pre-Test-Post-Test Control Group in order to determine the effect of the stress ball
      squeezing technique applied to children aged 7-12 during the vascular access procedure on the
      level of fear and pain in children. The data of the study were obtained from children aged
      7-12 who came to the Karaman Training and Research Hospital Pediatrics Service between August
      1 and October 31, 2020. The sample size was determined as 116 children in total, 58 children
      for each group. "Interview and Observation Form, Children's Fear Scale (CFS), Wong-Baker
      Faces, Stress Ball and Stopwatch" were used for data collection.

      In order to evaluate whether the research is ethically appropriate, an application was made
      to the Ethics Committee of Karamanoğlu Mehmetbey University School of Health Sciences and the
      necessary permission was obtained. Written permission was obtained from the Chief Physician
      of Karaman Training and Research Hospital in order to conduct the study in the Child Health
      and Diseases Service of Karaman Training and Research Hospital.

      Statistical analyzes of the study will be done in SPSS 21.0 package program. Number,
      percentage, mean and standard deviation values will be used from descriptive analyses. In the
      analysis of differences between groups, independent groups t test, paired t test, Anova, Mann
      Whitney U and Kruskal Wallis tests will be used. Tukey or Duncon tests will be used for
      further analysis. The change in the post-procedural pain level of children according to some
      variables will be evaluated with multiple and simple regression analyses. Significance level
      will be accepted as p<0.05.
    

Detailed description: 
      Dependent variable: Children's level of pain and fear Independent variable: Stress ball,
      demographics, previous painful transaction experience Randomization of control and stress
      ball groups; The status of the children to be included in the study in the control or stress
      ball group was determined by using "stratification and randomization methods with blocks". In
      the literature, it has been reported that gender and fear of interventional procedures are
      among the factors affecting the fear and anxiety experienced by children in interventional
      procedures (Törüner & Büyükgönenç, 2012; Çavuşoğlu, 2013). Accordingly, stratified and block
      randomization will be applied to the children as "girl and boy" for the gender variable and
      "afraid and not afraid" for the fear of the procedure. 58 children will be included in each
      of the research groups. During the data collection process, each child and family will be
      taken to the invasive procedure room individually. This will prevent children from meeting
      with each other.

      The determined layers were created by the statistician as codes obtained from a
      permutation-based computer program (https://www.randomizer.org). At the beginning of the
      study, which letter would be the stress ball or the control group was determined by the
      closed opaque envelope method, and the letter A was used for the stress ball group and the
      letter B was used for the control group.

      Blinding: Single blinding (participants) will be used in the study. Participants will not be
      told whether they are in a stress ball or control group. A separate informed consent form
      will be created and approved for each group. In order to prevent children and parents from
      encountering each other, information will be given in the closed operation room and their
      consent will be obtained. Each child will be taken to a separate room with one of their
      parents. It will be ensured that no child is waiting near the door for invasive intervention.

      Hypotheses H0: The stress ball applied during the vascular access procedure does not affect
      the fear and pain levels of children.

      H1: The stress ball applied during the venipuncture procedure affects the children's fear
      levels H2: The stress ball applied during the vascular access procedure affects the pain
      levels of children.

      H3: The stress ball applied during the venipuncture procedure affects the satisfaction of
      children, parents and nurses.

      The research will be carried out in the following order.

        1. Since the vascular access procedure will be performed by a single nurse, the children
           who are admitted to the service during the working day and time of the determined nurse
           and those whose parents are volunteers will be included in the study. Before the data
           collection phase, children and parents who meet the sample selection criteria of the
           research will be informed about the purpose and content of the research, and verbal and
           written consent will be obtained from their parents.

        2. Materials will be prepared beforehand (data collection tools, stress ball, stopwatch).

        3. Individual characteristics will be obtained from children and family members and
           recorded in the interview and observation form. Before the procedure, the fear level of
           children about the procedure will be recorded by asking the child, parent and observer
           separately using the Children's Fear Scale (CFS).

        4. The status of the child in the stress ball or control group will be determined by using
           layer sets.

        5. Children in the control group will be taken to the invasive procedure room and a parent
           will be with the child during the vascular access procedure. During the procedure, as
           soon as the children start to cry, the stopwatch will be started and will continue to
           run throughout the crying. After the procedure, the child's fear (Children's Fear Scale
           (CFS)) and pain (Wong-Baker FACES) related to the procedure will be evaluated separately
           by the child, parent and observer and recorded in the form.

        6. Children in the stress ball group will be asked to hold and squeeze the stress ball in
           their untreated hands before starting the vascular access process. A parent will be
           provided with the child during the procedure. A few seconds after the child starts
           squeezing the ball, the vascular access process will be started. The child will be asked
           to continue the process of squeezing the ball until the intravenous access is completed.
           During the procedure, as soon as the children begin to cry, the stopwatch will be
           started and will continue to run throughout the crying. After the procedure, the child's
           fear (Children's Fear Scale (CFS)) and pain (Wong-Baker FACES) related to the procedure
           will be evaluated separately by the child, parent and observer and recorded in the form.
    

Intervention name(s): Stress Ball
Intervention type(s): Other
Intervention description(s): Reducing pain and fear by squeezing a stress ball during the blood draw procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Pain; Turning Attention; Establishing intravascular access; Fear