Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination

NCT07779681 | Not Yet Recruiting

• 1 other identifier: HITIT-KPA-2026-05
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Cold spray; Helfer Skin Tap; Infant; Procedural pain; Vaccination

Outcome Measures

Primary Outcomes (1)

• Pain Level During Vaccination Assessed by FLACC Scale

  Pain level will be assessed using the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC). The FLACC scale evaluates five behavioral categories: face, legs, activity, cry, and consolability. Each category is scored from 0 to 2, and the total score ranges from 0 to 10. Higher scores indicate higher pain levels.

  During intramuscular pneumococcal conjugate vaccination

Secondary Outcomes (5)

• Pain Level Before and After Vaccination Assessed by FLACC Scale

  Before vaccination and immediately after vaccination

• Crying Duration

  During vaccination and immediately after vaccination

• Pulse Rate Before and After Vaccination

  Immediately before and immediately after vaccination

• Peripheral Oxygen Saturation Before and After Vaccination

  Immediately before and immediately after vaccination

• Body Temperature Before and After Vaccination

  Immediately before and immediately after vaccination

Study Arms (3)

Cold Spray Group

EXPERIMENTAL

Infants in this group will receive cold spray before intramuscular pneumococcal conjugate vaccination. Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before the vaccine injection.

Other: Cold spray

Helfer Skin Tap Group

EXPERIMENTAL

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

Other: Helfer Skin Tap Technique

Control Group

NO INTERVENTION

Infants in this group will receive routine intramuscular pneumococcal conjugate vaccination without any additional pain-reducing intervention.

Interventions

Cold spray OTHER

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

Cold Spray Group

Helfer Skin Tap Technique OTHER

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.

Helfer Skin Tap Group

Eligibility Criteria

• Age: 12 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parent or legal guardian has at least primary school education.
• Parent or legal guardian agrees for the infant to participate in the study.
• The infant is scheduled to receive the pneumococcal conjugate vaccine by - intramuscular injection.
• The infant was born between 38 and 42 weeks of gestation.
• The infant is 12 months old.
• The infant's body weight corresponds to the 50th percentile.

You may not qualify if:

• Parent or legal guardian is illiterate.
• The infant was born preterm or postterm.
• The infant attends the family health center for a vaccine other than the pneumococcal conjugate vaccine.
• The infant has a congenital anomaly, birth asphyxia, or any chronic disease.
• The infant received an analgesic medication within at least 4 hours before vaccination.

Sponsors & Collaborators

• Hitit University: lead

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Semra söngüt, Assistant Professor (Dr.)

CONTACT

+905380938989; karacaoglu_semra@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Dr.)

Model Details: Participants will be assigned to one of three parallel groups: cold spray, Helfer Skin Tap, or control. Each participant will receive only the intervention assigned to their group during intramuscular pneumococcal conjugate vaccination. The outcomes will be compared between the three groups.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share