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Not yet recruiting NCT07535151

The Study Aims to Determine the Effect of Using Animal-shaped Magic Mirrors During Vaccination in Children Aged 1-4 Years on the Child's Pain and the Mother's Anxiety.

Observational Mother's Anxiety Child's Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Mother's Anxiety, Child's Pain. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Effect of Magic Mirror Use on Child's Pain and Mother's Anxiety During Vaccine Administration in Children: Randomized Controlled Study

Overview

Vaccination is one of the most common invasive procedures performed on healthy infants and children. These procedures can cause pain and fear in children and anxiety in parents. This study will be conducted to determine the effect of using animal-shaped magic mirrors during vaccination on pain in children aged 1-4 years and anxiety in mothers.

Detailed description

The study is a randomized controlled experimental trial. Research data will be collected between February 1 and August 30, 2026. The study population will consist of children aged 1-4 years and their mothers who visit the Pediatrics Outpatient Clinic at Ankara Özel Koru Hospital. The sample will include 126 children and their mothers (Intervention group n=63; Control group n=63) who apply to the Ankara Koru Hospital Pediatric Outpatient Clinic for vaccination and meet the inclusion criteria. Children in the intervention group will be shown a magic mirror with animal figures at the moment of needle insertion during vaccination, while children in the control group will receive routine care without any intervention by the researchers. Data will be collected using the Informed Consent Form, the Eastern Ontario Children's Hospital Pain Scale, and the State Anxiety Inventory.

Descriptive statistics, Student's t-test or Mann Whitney U test for independent two-group comparisons, and t-test or Wilcoxon signed-rank test for dependent groups will be used in the analysis of the study. Statistical significance will be set at p\<0.05.

Expected Results: The findings from this study are expected to contribute to the development of new non-pharmacological methods to reduce pain experienced by children during vaccination and to reduce negative emotions such as anxiety associated with the procedure in parents.

Primary outcome measures

  • Information Sheet [Time frame: through study completion, an average of 3 mounth]

Eligibility criteria

Inclusion criteria

  • Mothers who have completed at least primary school and have no hearing, visual or intellectual disabilities.

Exclusion criteria

  • Children or their mothers who do not wish to participate during the vaccination process,
  • Children or their mothers who wish to withdraw from the study during the research process,
  • Those who provide incomplete answers to the study questions will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07535151 · 2025/500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗