The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration
- Conditions
- Vaccination
- Registration Number
- NCT06686992
- Lead Sponsor
- Ataturk University
- Brief Summary
The study will be conducted to examine the effect of distraction method on children's pain and fear levels during vaccine administration. The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
- Detailed Description
The research will be conducted in a randomized controlled experimental design in Family Health Centers in a province in eastern Turkey between November and December 2024. The population of the study will consist of children who come to the Family Health Center to receive the 4-year-old vaccine. The study will be completed with 50 intervention and 50 control groups, totaling 100 children. Child Diagnostic Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear Scale will be used to collect the data. Children in the intervention group will play the roll and draw game before and during vaccination. Children in the control group will receive routine vaccination. Research ethical principles will be followed.
Round and Draw game: The game designed by the researcher will be used as the intervention tool in the study. The game is played by creating a face picture by drawing the corresponding sections with the help of a dice consisting of 6x5 sections. With the game, it is planned to minimize pain and fear in children during vaccination. Care will be taken to ensure that the materials to be used are appropriate for the developmental level of the children, easy to clean and do not develop any allergies in children.
Data Collection The researcher will be present in the centers where the study will be conducted for 1 day to examine the ergonomic structure of the pediatric family health centers before starting to collect the data of the play group and control group children. The children and their parents will be given preliminary information about the research (the purpose of the research, why the research is being conducted, the use of the roll-and-draw game in relieving the child's pain and fear, etc.), and after obtaining verbal consent from the children and written consent from the parents, the data of the research will be obtained by face-to-face interview method with the children who agree to participate in the research.
Control Group: The questionnaires and scales will be filled in by the researcher 5 minutes before the vaccination process. Only routine 4-year-old vaccines will be administered. The scales will be filled out again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
Interventıon Group: The questionnaire and scales will be filled out by the researcher 5 minutes before vaccination. During the procedure, the child will be played with roll-and-draw. The scales will be filled in again 5 minutes after the procedure. It will take an average of 5-10 minutes to fill out the forms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Being 4 years old
- Not having a disability related to developmental areas
- The mother or father should be with the child during the procedure
- being older or younger than 4 years old
- having a chronic disease
- lack of willingness to work
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Wong-Baker Facial Expression Rating Scale (WB-FRAS) 1 months This scale is used to diagnose pain in children aged 3-18 years. In this scale, there are six faces representing increasing pain intensity from zero to five from left to right. The leftmost face has a smiling expression, indicating a pain-free state, while the rightmost face has a crying expression, corresponding to the most severe pain. The child is instructed to choose the face that best expresses their own emotions. Six facial expressions are scored from left to right from 0 to 5 points (0 points= very happy/no pain, 5 points= most severe pain). As the score obtained from the scale increases, pain tolerance decreases and as the score decreases, tolerance increases.
Child Fear Scale 1 months The Child Fear Scale was developed in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 scale with five faces ranging from neutral (0 = no concern at all) to fearful (4 = severe concern).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ataturk University Nursing of Faculty
🇹🇷Erzurum, Turkey