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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | group shown in the magic mirror | ||
| 2 | group not shown in the magic mirror |
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| Measure | Description | Time Frame |
|---|---|---|
| Information Sheet | 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. | through study completion, an average of 3 mounth |
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| Measure | Description | Time Frame |
|---|---|---|
| State Anxiety Inventory | 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. |
Inclusion Criteria:
Exclusion Criteria:
female
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Children aged 1-4 who have been referred by a paediatric outpatient clinic doctor for vaccination, and their mothers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| neslihan durna, 1 | Contact | +905415392879 | neslihndrna@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr. Hüsniye ÇALIŞIR, 1 | ADNAN MENDERES ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ | Principal Investigator |
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All medical and personal details relating to the participant will be kept confidential, and no personal details will be disclosed even if the research is published; however, study monitors, auditors, ethics committees and official authorities may access your medical information where necessary
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| through study completion, an average of 3 mounth |
| Eastern Ontario Children's Hospital Pain Scale (EOCHAS) | 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. | through study completion, an average of 3 mounth |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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