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Comparison of eye protection and earmuffs on pain intensity and heart rate during vaccination

Comparison of eye protection and earmuffs on pain intensity and heart rate of infants during vaccination

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210501051142N11
Enrollment
108
Registered
2024-11-06
Start date
2024-11-10
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Pain intensity. Condition 2: heart rate. Acute pain, not elsewhere classified

Interventions

Intervention 1: Intervention group: In the eye protection group, eye protection will be placed on the infant from 15 minutes before the pentavalent vaccine injection to 15 minutes after the pentavalen

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Months to 6 Months

Inclusion criteria

Inclusion criteria: Absence of congenital anomalies and genetic disorders Not receiving painkillers that affect the physiological and behavioral state of the child, such as anticonvulsants and narcotic sedatives Not having a painful procedure at least one hour before the intervention

Exclusion criteria

Exclusion criteria: Extreme restlessness of the child Presence of an abnormality in the facial area (cleft lip, cleft palate)

Design outcomes

Primary

MeasureTime frame
Pain intensity. Timepoint: During vaccine injection and 15 minutes after injection. Method of measurement: Pain intensity is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. In this study, the intensity of infant pain during vaccine injection and 15 minutes after is measured by the FLACC scale.;Heart rate. Timepoint: 15 minutes before, during and 15 minutes after the injection. Method of measurement: Heart rate: The number of times the heart beats in a given period of time, usually in one minute. In this study, the infant's heart rate will be measured 15 minutes before, during and 15 minutes after the injection using C29 pulse oximetry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahbobeh Sajadi

Arak University of Medical Sciences

golmehrsherafati@gmail.com009886341735057

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026