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Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination

NCT07779681 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-08-21

No results posted yet for this study

Summary

This randomized controlled experimental study aims to evaluate the effects of cold spray and the Helfer Skin Tap technique on pain levels during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants.

Vaccination is one of the most common painful procedures during infancy. Pain experienced during injections may cause distress in infants and anxiety in families. Therefore, simple, safe, non-pharmacological methods that can reduce injection-related pain are important in pediatric nursing and primary health care.

The study will be conducted at Çorum Söğütlüevler Family Health Center between March 2026 and March 2027. The study population will consist of 12-month-old infants who attend the family health center for intramuscular pneumococcal conjugate vaccination. A total of 120 infants are planned to be included in the study. Participants will be assigned to one of three groups by stratified block randomization: cold spray group, Helfer Skin Tap group, or control group. Each group will include 40 infants.

Infants in the control group will receive routine vaccination without any additional intervention. In the cold spray group, cold spray will be applied to the injection site before vaccination. In the Helfer Skin Tap group, the technique will be applied before and during the injection by gently tapping near the injection site in coordination with needle insertion.

Data will be collected using a Child Information Form, an Application Record Form, and the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). Pain responses will be evaluated before, during, and after vaccination. Crying duration and physiological parameters such as pulse, oxygen saturation, and body temperature will also be recorded.

The findings of this study are expected to contribute to evidence-based pediatric nursing practices by identifying whether cold spray or the Helfer Skin Tap technique is effective in reducing pain during infant vaccination.

Conditions

  • Procedural Pain
  • Vaccination Pain
  • Injection Pain

Interventions

OTHER

Cold spray

Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before intramuscular pneumococcal conjugate vaccination.

OTHER

Helfer Skin Tap Technique

The Helfer Skin Tap technique will be applied before and during intramuscular pneumococcal conjugate vaccination by tapping near the injection site in coordination with needle insertion.

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-09-01
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07779681 on ClinicalTrials.gov