Venous Blood Sampling-Related Pain and Fear
Condition: Pain; Fear
Study type: Interventional

Summary: 
      This study is an experimental randomized controlled study conducted to compare the effect of
      balloon blowing, coughing, and ball squeezing methods applied during venous blood sampling
      from on pain and fear level in 7-12 year-old children. The population of the study consisted
      of all 7-12 year-old children who were referred to the blood-letting room for venous blood
      sampling in a state hospital. The sample of the study was determined as 120 children with
      confidence level of 95% and theoretical power of 95%. The children were divided into 4 groups
      of 30 people, including balloon blowing, ball squeezing, coughing, 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 population of the
      study consisted of all 7-12 year-old children who came to the venipuncture room in the state
      hospital.It is stated in the literature that the sample size should be determined as minimum
      30 in both experimental and control groups in the experimental studies and parametric
      measurements. Therefore, in the study, each group included 30 children including three
      experimental groups and a control group and in the power analysis, power of the study was
      found as 0.95 at the confidence level of 95%. 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:120), their
      parents as the people who know the children best (n:120), and a researcher specialized in
      pediatric nursing (n:1), and the inter-observer agreement was examined. The level of pain was
      assessed by the Wong Baker Faces Scale and the fear of pain was assessed by the Children's
      Fear Scale.

      In this experimental study, the children and their parents who came to the venipuncture room
      for venous blood sampling were evaluated in terms of the inclusion criteria and the children
      and parents who did not meet the criteria were excluded from the study. The children and
      parents complying with the inclusion criteria were informed about the study and their written
      and verbal consents were received. The children were included in one of the 4 study groups,
      including the balloon blowing, coughing, ball squeezing, and the control group without any
      intervention. In the studies, it was determined that gender had an important effect on
      evaluation of pain.39,40 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
      method in four 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.
    

Intervention name(s): Balloon Blowing; Ball Squeezing; Coughing; Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The parents of the children in this group were asked whether their children had the latex allergy or not and the children without the allergy were included in the group. The children's skills of blowing balloon were observed before the procedure. Before starting the venous blood sampling procedure, the children were asked to choose a balloon in the color they preferred and to start blowing the balloon at least 20 seconds before the procedure. Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons.; Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure.; The children included in this group were asked to cough after taking a deep breath during the venous blood sampling procedure. Before the procedure, the researcher showed the children how they should cough and asked them to imitate. The venous blood sampling was not performed until the child successfully completed coughing. The child was directed by the researcher during the procedure. Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing.; No intervention was performed to reduce pain and fear in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pain management; pain in children; venous blood sample; non-pharmacological method