NCT07535151

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2026Aug 2026

Study Start

First participant enrolled

March 27, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

March 29, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

PainAnxietyVaccinationDistractionParent

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (2)

  • State Anxiety Inventory

    through study completion, an average of 3 mounth

  • Eastern Ontario Children's Hospital Pain Scale (EOCHAS)

    through study completion, an average of 3 mounth

Study Arms (2)

1

group shown in the magic mirror

2

group not shown in the magic mirror

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Children aged 1-4 who have been referred by a paediatric outpatient clinic doctor for vaccination, and their mothers

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Prof.Dr. Hüsniye ÇALIŞIR, 1

    ADNAN MENDERES ÜNİVERSİTESİ SAĞLIK BİLİMLERİ FAKÜLTESİ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

neslihan durna, 1

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neslihan Durna

Study Record Dates

First Submitted

March 29, 2026

First Posted

April 16, 2026

Study Start

March 27, 2026

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04