Investigating the effect of the Helfer technique in the facilitated position on the pain caused by hepatitis B vaccine injection in term neonates.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241030063551N1

Enrollment

184

Registered

2024-12-15

Start date

2025-01-09

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

A study on the vaccination of term infants using the Helfer technique and facilitated position in order to reduce the pain caused by vaccination.

Interventions

Intervention group:.

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Criteria for entering the study: various factors are effective in understanding babies and creating a response, for this reason, term babies (at 37 to 42 weeks), babies with a normal Apgar score of 7-10, birth weight greater than 2500 grams without congenital abnormalities And without respiratory distress and heart problems at birth And things like breastfeeding the baby (at least 30 minutes to a maximum of one hour) and the cleanliness of the baby's diaper before the intervention were included in the study

Exclusion criteria

Exclusion criteria: Including babies who have medical problems during the study Parents' non-cooperation and withdrawal from the study

Design outcomes

Primary

Measure	Time frame
Pain intensity during and after hepatitis B vaccine injection using neonatal/infant pain scale(NIPS). Timepoint: The moment the needle enters the muscle - during the injection - one minute after the injection. Method of measurement: Neonatal/Infant Pain Scale -This scale examines crying, facial expressions, breathing patterns, movements of hands, legs, and the baby's level of consciousness. In this scale, to the crying option: (score zero, one and two) score zero: calm, score one: moaning, score two: intense crying (facial expression: score zero, one) score zero: calm, score one: frowning Breathing pattern: score zero, one) score zero: natural, score one: change in the natural breathing pattern (movements of hands and feet: score zero, one) score zero: normal, score one: flexion and extension(Consciousness level: score zero, one) score zero: asleep or awake, score one: yelling is given.	—

Measure

Time frame

Pain intensity during and after hepatitis B vaccine injection using neonatal/infant pain scale(NIPS). Timepoint: The moment the needle enters the muscle - during the injection - one minute after the injection. Method of measurement: Neonatal/Infant Pain Scale -This scale examines crying, facial expressions, breathing patterns, movements of hands, legs, and the baby's level of consciousness. In this scale, to the crying option: (score zero, one and two) score zero: calm, score one: moaning, score two: intense crying (facial expression: score zero, one) score zero: calm, score one: frowning Breathing pattern: score zero, one) score zero: natural, score one: change in the natural breathing pattern (movements of hands and feet: score zero, one) score zero: normal, score one: flexion and extension(Consciousness level: score zero, one) score zero: asleep or awake, score one: yelling is given.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKianaGhaffarinejad

Mashhad University of Medical Sciences

kianaghaffarinejad@gmail.com+98 34 3243 7518

Outcome results

None listed

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