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

NCT ID: NCT06686992

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-03-12

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.

Conditions

Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

distraction

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.

Group Type: EXPERIMENTAL

Vaccination

Intervention Type: BEHAVIORAL

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.

control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vaccination

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

ARZU SARIALİOĞLU

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University Nursing of Faculty

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.ATA.0.01.00/134

Identifier Type: -

Identifier Source: org_study_id