Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants

Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard. The primary goal of pain management is to accurately assess and identify the infant's pain at an early stage, support the development of coping mechanisms through both pharmacological and non-pharmacological methods, and minimize the pain experience as much as possible. Pain management achieved through non-pharmacological interventions constitutes a safe, non-invasive, cost-effective, and independently performed nursing practice. This randomized controlled study was conducted to determine the effect of non-pharmacological methods, specifically maternal holding and breastfeeding, on reducing pain during vaccination in infants.

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Key information

Conditions

Pain Behavior Breast Feeding Feeding Behavior Maternal Behavior Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yalova University

Yalova, 77200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Being healthy,
Aged between 4 weeks and 6 months,
Parents have given verbal and written consent to participate in the study,
Born at term (37 weeks of gestation or later),
Scheduled for vaccination under the Ministry of Health's vaccination program,
Not having taken analgesics/antipyretics in the last 4 hours before the procedure,
Having a normal body temperature (between 36.5°C and 37.1°C).

Exclusion criteria

Having a chronic or mental illness, or a congenital anomaly,
Being older than 6 months,
Having a body temperature above 37.1°C,
Receiving analgesics, sedatives, or any other medication.

Treatment and study plan

Maternal Holding Intervention Group

Behavioral

The infant is required to be held in the mother's arms before, during, and after the procedure. The maternal holding method will be shown or explained to the mother by the researchers.

Breast Feeding Intervention Group

Behavioral

The infant's mother is instructed to begin breastfeeding 2 minutes before the procedure, continuing during and after the procedure. The breastfeeding position for the infant will be shown or explained to the mother by the researchers.

Primary outcomes

Evaluation of pain and crying duration in the infant held in the mother's arms during the vaccination procedure

Time frame: Two minutes before the procedure, during the procedure, and three minutes after the procedure.

The pain of the infant held in the mother's arms will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 3 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.
Evaluation of pain and crying duration in the infant held in the breast feeding during the vaccination procedure

Time frame: Two minutes before the procedure, during the procedure, and three minutes after the procedure.

The pain of the infant using the breastfeeding method will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 2 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

The Effect of Breastfeeding and Maternal Holding on Reducing Pain During Vaccination in Infants

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Mar 20, 2025
Registry last updated: Jul 15, 2025

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.

Published trials that share one or more normalized conditions with this study.

Completed