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NCT Number: 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.

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Information Sheet

    Time frame: through study completion, an average of 3 mounth

    This form contains the socio-demographic characteristics of the mother and child. In addition to basic information such as the child's age and gender, and the mother's age, educational level, employment status and the family's income level, the form also includes details regarding the presence of chronic illnesses in the child and mother, as well as information on the child's vaccination history.The information form consists of a total of 12 questions.

Other outcomes

  1. State Anxiety Inventory

    Time frame: through study completion, an average of 3 mounth

    State Anxiety (S) assesses the level of anxiety an individual feels at a specific moment. The scale consists of 20 items. A 4-point Likert-type rating scale is used (1 = Not at all, 4 = Very much). Some items are scored directly, whilst others are reverse-scored. In the reverse-scored items, a response of 4 indicates low anxiety, whilst a response of 1 indicates high anxiety. The State Anxiety Scale contains 10 reverse-scored items (items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20) (Telli, 2017). The total score ranges from 20 to 80, with a higher score indicating an increased level of anxiety.

  2. Eastern Ontario Children's Hospital Pain Scale (EOCHAS)

    Time frame: through study completion, an average of 3 mounth

    The Eastern Ontario Children's Hospital Pain Scale is a measure that assesses behavioural parameters used to evaluate pain. The scale, which can be used to monitor the effectiveness of interventions aimed at reducing pain and improving comfort, comprises six parameters. The pain score is calculated as the total of the scores for all six parameters, with a minimum score of 4 and a maximum score of 13. The researcher will assess pain by observing the behaviours listed in the scale items.

Study contacts

Contact information is provided by the study sponsor or research team.

neslihan durna, 1

CONTACT

[email protected]

+905415392879

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Acronym: MAGİC MİRROR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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