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

NCT06686992 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/134
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination

Keywords

pain; fear; vaccine; nursing; distraction; child

Outcome Measures

Primary Outcomes (2)

• Wong-Baker Facial Expression Rating Scale (WB-FRAS)

  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.

  1 months

• Child Fear Scale

  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).

  1 months

Study Arms (2)

distraction

EXPERIMENTAL

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.

Behavioral: Vaccination

control

NO INTERVENTION

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.

Interventions

Vaccination 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.

distraction

Eligibility Criteria

• Age: 4 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Nursing of Faculty

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Vaccination

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 13, 2024
• Study Start: November 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 12, 2025
• Last Updated: March 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)