Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants

NCT ID: NCT06886412

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-02
• Study Completion Date: 2025-04-25

Brief Summary

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.

Conditions

Pain; Breast Feeding; Maternal Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Maternal Holding Group

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.

Group Type: EXPERIMENTAL

Maternal Holding Intervention Group

Intervention Type: 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 Group

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.

Group Type: EXPERIMENTAL

Breast Feeding Intervention Group

Intervention Type: 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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Maternal Holding Intervention Group

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.

Intervention Type: BEHAVIORAL

Breast Feeding Intervention Group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Yalova

OTHER

Sponsor Role: lead

Responsible Party

Emel AVÇİN

Lecturer Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EMEL AVÇİN, Doctor

Role: PRINCIPAL_INVESTIGATOR

University of Yalova

Locations

Yalova University

Yalova, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Emel Avcin Pain

Identifier Type: -

Identifier Source: org_study_id