Procedural PainNCT07779681
Cold Spray and Helfer Skin Tap for Pain During Infant Vaccination
A study testing Cold spray and Helfer Skin Tap Technique in people with Procedural Pain and Vaccination Pain, run by Hitit University.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Vaccination Pain, Injection Pain
- What is being tested?
- Cold spray and Helfer Skin Tap Technique
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Cold Spray and Helfer Skin Tap Technique Used in Intramuscular Vaccinatıon on Pain Levels
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.
Read more
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.
Read the detailed description
Pain during vaccination is a common source of distress for infants and concern for families. Since infants cannot verbally express pain, behavioral pain assessment tools are needed to evaluate their pain responses during painful procedures. Non-pharmacological methods that are simple, low-cost, and easy to apply may help reduce injection-related pain in primary health care settings.
This study is designed to compare two non-pharmacological pain management methods, cold spray and the Helfer Skin Tap technique, during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants. The study will be conducted in a family health center setting, where routine infant vaccinations are performed.
Eligible infants will be randomly assigned to one of three groups: a cold spray group, a Helfer Skin Tap group, or a control group. In the control group, infants will receive the routine intramuscular vaccine injection without any additional pain-reducing intervention. In the cold spray group, cold spray will be applied to the injection site before the vaccine injection. In the Helfer Skin Tap group, the researcher will apply rhythmic tapping near the injection area before and during needle insertion according to the technique.
Pain will be assessed using the Face, Legs, Activity, Cry, Consolability Pain Scale, known as the FLACC scale. Pain responses will be evaluated before, during, and after the vaccination procedure. Crying duration will also be recorded as an additional behavioral indicator of pain. Physiological parameters, including pulse, oxygen saturation, and body temperature, will be measured before and after the injection.
The study aims to determine whether cold spray or the Helfer Skin Tap technique reduces pain compared with routine vaccination practice and whether one method is more effective than the other. The results may provide evidence for pediatric nurses and primary health care professionals on the use of practical non-pharmacological pain management methods during infant vaccination.
- Conditions
- Procedural Pain, Vaccination Pain, Injection Pain
- Being tested
- Cold spray, Helfer Skin Tap Technique
- Keywords
- Cold spray, Helfer Skin Tap, Infant, Procedural pain, Vaccination
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold sprayOther
Cold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before intramuscular pneumococcal conjugate vaccination.
Helfer Skin Tap TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intramuscular pneumococcal conjugate vaccination
Secondary outcomes (5)
Pain Level Before and After Vaccination Assessed by FLACC Scale
Pain level will be assessed before and after vaccination using the FLACC scale. The total score ranges from 0 to 10, with higher scores indicating higher pain levels.
Measured: Before vaccination and immediately after vaccination
Crying Duration
Crying duration will be recorded in seconds using a stopwatch during and after the vaccination procedure. Longer crying duration indicates greater behavioral distress.
Measured: During vaccination and immediately after vaccination
Pulse Rate Before and After Vaccination
Pulse rate will be measured immediately before and immediately after vaccination and recorded in beats per minute (bpm).
Measured: Immediately before and immediately after vaccination
Peripheral Oxygen Saturation Before and After Vaccination
Peripheral oxygen saturation (SpO₂) will be measured immediately before and immediately after vaccination and recorded as a percentage (%).
Measured: Immediately before and immediately after vaccination
Body Temperature Before and After Vaccination
Body temperature will be measured immediately before and immediately after vaccination and recorded in degrees Celsius (°C).
Measured: Immediately before and immediately after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semra SÖNGÜT, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779681
- Sponsor's protocol ID
- HITIT-KPA-2026-05
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study population consists of 12-month-old infants, and the collected data include sensitive health-related information. Data will be used only by the research team for the purposes of this study. Results will be reported in aggregate form without identifying individual participants.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cold Spray and Helfer Skin Tap Technique Used in Intramuscular Vaccinatıon on Pain Levels
- ClinicalTrials.gov ID
- NCT07779681
- Acronym / sponsor ID
- HITIT-KPA-2026-05
- Conditions
- Procedural Pain, Vaccination Pain, Injection Pain
- Keywords
- Cold spray, Helfer Skin Tap, Infant, Procedural pain, Vaccination
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain during vaccination is a common source of distress for infants and concern for families. Since infants cannot verbally express pain, behavioral pain assessment tools are needed to evaluate their pain responses during painful procedures. Non-pharmacological methods that are simple, low-cost, and easy to apply may help reduce injection-related pain in primary health care settings.
This study is designed to compare two non-pharmacological pain management methods, cold spray and the Helfer Skin Tap technique, during intramuscular pneumococcal conjugate vaccine administration in 12-month-old infants. The study will be conducted in a family health center setting, where routine infant vaccinations are performed.
Eligible infants will be randomly assigned to one of three groups: a cold spray group, a Helfer Skin Tap group, or a control group. In the control group, infants will receive the routine intramuscular vaccine injection without any additional pain-reducing intervention. In the cold spray group, cold spray will be applied to the injection site before the vaccine injection. In the Helfer Skin Tap group, the researcher will apply rhythmic tapping near the injection area before and during needle insertion according to the technique.
Pain will be assessed using the Face, Legs, Activity, Cry, Consolability Pain Scale, known as the FLACC scale. Pain responses will be evaluated before, during, and after the vaccination procedure. Crying duration will also be recorded as an additional behavioral indicator of pain. Physiological parameters, including pulse, oxygen saturation, and body temperature, will be measured before and after the injection.
The study aims to determine whether cold spray or the Helfer Skin Tap technique reduces pain compared with routine vaccination practice and whether one method is more effective than the other. The results may provide evidence for pediatric nurses and primary health care professionals on the use of practical non-pharmacological pain management methods during infant vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cold Spray Group | Experimental | Other: Cold sprayInfants 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. |
| Helfer Skin Tap Group | Experimental | Other: Helfer Skin Tap TechniqueInfants 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. |
| Control Group | No intervention | –Infants in this group will receive routine intramuscular pneumococcal conjugate vaccination without any additional pain-reducing intervention. |
Who may qualify
- Ages
- 12 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold sprayCold spray will be applied to the injection site from a distance of 15 cm for 5 seconds before intramuscular pneumococcal conjugate vaccination. | Other | Cold Spray Group |
| Helfer Skin Tap TechniqueThe 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. | Other | Helfer Skin Tap Group |
Primary outcome
Pain Level During Vaccination Assessed by FLACC Scale
Time frame: During intramuscular pneumococcal conjugate vaccination
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.
5 secondary outcomes
Pain Level Before and After Vaccination Assessed by FLACC Scale
Time frame: Before vaccination and immediately after vaccination
Crying Duration
Time frame: During vaccination and immediately after vaccination
Pulse Rate Before and After Vaccination
Time frame: Immediately before and immediately after vaccination
Peripheral Oxygen Saturation Before and After Vaccination
Time frame: Immediately before and immediately after vaccination
Body Temperature Before and After Vaccination
Time frame: Immediately before and immediately after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study population consists of 12-month-old infants, and the collected data include sensitive health-related information. Data will be used only by the research team for the purposes of this study. Results will be reported in aggregate form without identifying individual participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cold spray and Helfer Skin Tap Technique in people with Procedural Pain and Vaccination Pain, run by Hitit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semra söngüt, Assistant Professor (Dr.) (+905380938989, karacaoglu_semra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level During Vaccination Assessed by FLACC Scale (time frame: During intramuscular pneumococcal conjugate vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.