The Effect of Therapeutic Play Applied With Puppet
Condition: Bloodletting
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of therapeutic play applied with a hand
      puppet during blood collection on pain and fear in children. The project is a randomized
      controlled trial. The study includes children aged 3-6 years who came to the pediatric blood
      collection unit of Binali Yıldırım University Mengücek Gazi Training and Research Hospital
      between 01/07/2022 and 01/01/2023. The research sample; children who apply to the unit on the
      specified dates and meet the research criteria and volunteer to participate in the research.
      "Survey Form", "Wong-Baker Evaluation of Facial Expressions Scale" and "Child Fear Scale"
      will be used in data collection.
    

Detailed description: 
      Type of Study: The study is a randomized controlled trial. Population and Sample of the
      Research: The population of the research includes children aged 3-6 years who came to the
      pediatric blood collection unit of Binali Yıldırım University Mengücek Gazi Training and
      Research Hospital between 01/07/2022-01/01/2023.

      The research sample; "Children who apply to the blood collection unit on the specified dates
      and meet the research criteria and volunteer to participate in the research". In this study,
      "prior power analysis" was conducted to determine sample adequacy. In the Priori power
      analysis, "Cohen's method of reference to standard effect sizes" was chosen. In this case, in
      our study, the effect of the therapeutic game applied with a hand puppet during blood
      collection on pain and fear in children will be compared. It has been determined that 80%
      power can be reached. It was decided to collect data from a total of 100 individuals by
      including 10% backup sample in this number in case of data loss. Data collection will not be
      carried out simultaneously in the puppet and control groups, in case the children in the
      clinic are affected by the puppet toys. In order to ensure randomization, the children who
      met the criteria will be included in the control group in the first week, and the children
      who come in the second week will be taken into the puppet group, and this cycle will be
      continued until the end of the study, and randomization will be ensured.

      Data Collection Tools to be Used in the Study: "Survey Form, Wong-Baker Facial Expression
      Evaluation Scale and Child Fear Scale" will be used to collect research data. As an
      intervention tool in the research, a hand puppet designed together with the researcher and
      child development specialist will be used.

      Questionnaire Form: In the questionnaire form created by the researchers by scanning the
      literature; There are questions addressing the introductory characteristics of the research
      group.

      Intervention Tools to be Used in the Research Hand puppet: A hand puppet designed together
      with the researcher and child development specialist will be used as an intervention tool in
      the research. In this context, the researcher received play therapy training. While the
      puppet is being designed, it will be ensured that it is integrated in the hospital
      environment and it will be ensured that the child is not alienated to the environment he/she
      comes from. The researcher, who received play therapy training in hand puppet practice, plans
      to reduce the children's fears and reduce the level of pain before the intervention. While
      designing the hand puppet, care will be taken to ensure that the materials to be used are
      antiallergenic and made of fabric that can be easily sterilized after each child the
      application is made.

      Data Collection The researcher will stay in the pediatric blood collection unit for 1 day in
      order to examine the ergonomic structure of the pediatric blood collection unit before
      collecting the data of the puppet group and control group children. Parents were informed
      about the research (the purpose of the research, why the research was conducted, the use of a
      puppet toy to relieve the child's pain and fear, etc.), after giving verbal consent from the
      children and written consent from the parents. Afterwards, the data of the research will be
      obtained by face-to-face interview method with the children who accepted to participate in
      the research.

      Control Group: Questionnaires and scales will be filled in the control group 5 minutes before
      the blood draw is done by the researcher. Only routine applications will be made. 5 minutes
      after the procedure, the scales will be filled again. Filling out the forms will take 5-10
      minutes on average.

      Puppet Group: Questionnaires and scales will be filled in 5 minutes before the blood draw is
      done by the researcher. It will be played with the puppet during the process. 5 minutes after
      the procedure, the scales will be filled again. Filling out the forms will take 5-10 minutes
      on average.

      Evaluation of Data The processing and statistical analysis of the collected data will be done
      with the analysis software called SPSS (Statistical Package for the Social Sciences) for
      Windows 20.0.

      Ethical Principles of Research In order to carry out the research, official permission from
      the relevant institution will be obtained from the Ethics Committee with ethical approval.
      Children who meet the criteria of the research group will be informed about the purpose of
      the study, their questions will be answered, and their verbal and written consent will be
      obtained. Parents and children will be informed that the data collected during the research
      will be processed anonymously, confidentially, and will not be used outside of the study in
      question, and that they can leave the study whenever they wish. Since the research is based
      on the use of data obtained from humans, and therefore, due to the necessity of observing
      personal rights, the relevant ethical principles "Informed Consent", "Volunteerism" and
      "Protection of Confidentiality" will be followed. After the blood collection process is
      completed, the children in the control group will be played with a puppet and the "Principle
      of Equality" will be tried to be fulfilled.
    

Intervention name(s): puppet
Intervention type(s): Behavioral
Intervention description(s): pain and fear during blood collection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care