The Effect of Distraction Method on Children's Pain and Fear Levels During Vaccine Administration

Ataturk University

Status: Not yet enrolling

Conditions: Vaccination

Treatments: Behavioral: Vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT06686992

B.30.2.ATA.0.01.00/134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

distraction

Experimental group

Description:

The researcher will fill in the questionnaire and scales 5 minutes before the 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.

Treatment:

Behavioral: Vaccination

control

No Intervention group

Description:

Questionnaires and scales will be filled out by the researcher 5 minutes before vaccination. Only routine applications will be made. The scales will be filled again 5 minutes after vaccination.