Clinical trial NCT06686992: The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration
Official title: The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccination
Keywords: pain
fear
vaccine
nursing
distraction
child
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Being 4 years old
* Not having a disability related to developmental areas
* The mother or father should be with the child during the procedure

Exclusion Criteria:

* being older or younger than 4 years old
* having a chronic disease
* lack of willingness to work

Primary outcomes:
measure: Wong-Baker Facial Expression Rating Scale (WB-FRAS)
timeFrame: 1 months
measure: Child Fear Scale
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Nursing of Faculty
Study officials:
References: