Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants

University of Yalova

Status: Completed

Conditions: Breast Feeding; Maternal Behavior; Pain

Treatments: Behavioral: Breast Feeding Intervention Group; Behavioral: Maternal Holding Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06886412

Emel Avcin Pain

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Maternal Holding Group

Experimental group

Description:

Five minutes before the vaccination procedure, the infant will be handed to the mother in a position suitable for vaccination and will remain in her arms throughout the procedure. It will be checked that the infant's diaper has been changed..The mother will be informed about the importance of stabilizing the leg to be vaccinated during the procedure and will be instructed to hold the infant in a comfortable position. The mother will hold the infant in her lap, using one arm and hand to secure the infant's arms and the other arm and hand to hold the infant's legs. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure.

Treatment:

Behavioral: Maternal Holding Intervention Group

Breast Feeding Group

Experimental group

Description:

Before the vaccination procedure, the infant and mother will be taken to the vaccination room. The infant's diaper will be checked to ensure it has been changed. The mother will be asked whether the infant has been fed at least 30 minutes before the procedure. The mother will be instructed to sit comfortably on the examination table with her back supported against the wall. The mother will then take the infant in her arms, and the infant will be placed in a cradle hold breastfeeding position. The infant will be handed to the mother 2 minutes before the procedure, and breastfeeding will begin. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure.

Treatment:

Behavioral: Breast Feeding Intervention Group

Control Group

No Intervention group

Description:

The infants in the control group will receive their vaccinations in the same manner as routine vaccination procedures. Before the vaccination procedure, the infant and their parent will be taken to the room where the procedure will take place, and the infant will be laid on the examination table. During the procedure, the mother will remain next to her infant. To restrict the movement of the infant's legs during the vaccination, the nurse will stabilize the infant's leg with one hand while performing the procedure with the other hand. No non-pharmacological methods will be applied during the procedure. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure.