PainNCT06246266
Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique
A study testing Helfer Skin Tap Technique group and ShotBlocker Technique group in people with Pain, run by Ondokuz Mayıs University.
Trial summary
The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Helfer Skin Tap Technique group and ShotBlocker Technique group
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 5 Feb 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 38 and 42 weeks of gestation,
- Between 2 and 4 months old,
- Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
- No congenital anomalies, birth asphyxia or any chronic disease
Who cannot join
- Born prematurely or postmaturely
- Not between 2 and 4 months old
- Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
- Those with congenital anomalies, birth asphyxia or any chronic disease
About this study
Official title: Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique in Reducing Pain in Babies Receiving Intramuscular Vaccination
The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.
Read the detailed description
During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited.
Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.
- Conditions
- Pain
- Being tested
- Helfer Skin Tap Technique group, ShotBlocker Technique group
- Keywords
- infant, ıntramuscular, vaccine, Helfer Skin Tap Technique, ShotBlocker, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer Skin Tap Technique groupProcedure or surgery
During intramuscular vaccine administration, the muscle will be tapped with the palmar surface of the fingers of the other hand that is not used, with light rhythmic movements, counting for 1-15 seconds. Then, when the muscle is entered with the injection, it will continue to be hit with light rhythmic movements for 1-3 seconds. Thus, the muscle will relax and the fibers around the muscle will be stimulated. Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention.
ShotBlocker Technique groupProcedure or surgery
The protruding but not sharp surface on the ShotBlocker tool will be placed on the baby's skin before intramuscular vaccine administration.
Injection will be applied to the middle part of this vehicle, which has a 'U' appearance. This tool, which does not cause any harm to the skin surface, will provide stimulation to the muscle fibers according to the Gate Control Theory related to pain.
| Study group | Role | What they receive |
|---|---|---|
| Helfer Skin Tap Technique group | Experimental | Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention. Receives: Procedure: Helfer Skin Tap Technique group |
| ShotBlocker Technique group | Experimental | During intramuscular vaccine administration to babies, the injection ShotBlocker Technique will be applied using the ShotBlocker tool (a tool with a "U" appearance, with blunt but not pointed protrusions). Receives: Procedure: ShotBlocker Technique group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale = NIPS
The Newborn-Infant Pain Scale, developed by Lawrence et al. (1993) to evaluate the physiological and behavioral responses of newborns to pain, was adapted into Turkish by Akdovan (1999). Scale; It consists of five behavioral and one physiological parts, including facial expression, crying, breathing pattern, arm and leg movements, and sleep-wake state. The crying part of the scale is given 0-1 and 2 points, and the other parts are given 0-1 point. The total score can range from 0 to 7, and a score higher than 3 indicates greater pain intensity.
Measured: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start5 Feb 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra TURAL BUYUK, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246266
- Sponsor's protocol ID
- Helfer Skin Tap
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Helfer Skin Tap Technique and ShotBlocker Technique in Reducing Pain in Babies Receiving Intramuscular Vaccination
- ClinicalTrials.gov ID
- NCT06246266
- Acronym / sponsor ID
- Helfer Skin Tap
- Conditions
- Pain
- Keywords
- infant, ıntramuscular, vaccine, Helfer Skin Tap Technique, ShotBlocker, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
The purpose of this study is to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.
Detailed description
During immunization, babies feel pain from the injection and give behavioral reactions such as crying and struggling in response to this pain. Pain-reducing methods (Buzzy device, cold application, hot application, music, virtual reality, distracting cards, stress ball, etc.) are used during intramuscular vaccine injection in children. Studies using the Helfer Skin Tap Technique and ShotBlocker Technique, which are easy to apply and proven effective in reducing pain in infancy vaccination applications, are limited.
Therefore, this study aims to examine the effectiveness of the Helfer Skin Tap Technique and the ShotBlocker Technique in reducing pain in babies receiving intramuscular vaccination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Helfer Skin Tap Technique group | Experimental | Procedure: Helfer Skin Tap Technique groupMechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention. |
| ShotBlocker Technique group | Experimental | Procedure: ShotBlocker Technique groupDuring intramuscular vaccine administration to babies, the injection ShotBlocker Technique will be applied using the ShotBlocker tool (a tool with a "U" appearance, with blunt but not pointed protrusions). |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Born between 38 and 42 weeks of gestation,
- Between 2 and 4 months old,
- Applying to the family health center for KPA (Conjugated Pneumococcal Vaccine) application,
- No congenital anomalies, birth asphyxia or any chronic disease
Key exclusion criteria (4 listed)
- Born prematurely or postmaturely
- Not between 2 and 4 months old
- Those who come to the family health center for the administration of other vaccines other than the KPA (Conjugated Pneumococcal Vaccine) application administered via IM route.
- Those with congenital anomalies, birth asphyxia or any chronic disease
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 |
|---|---|---|
| Helfer Skin Tap Technique groupDuring intramuscular vaccine administration, the muscle will be tapped with the palmar surface of the fingers of the other hand that is not used, with light rhythmic movements, counting for 1-15 seconds. Then, when the muscle is entered with the injection, it will continue to be hit with light rhythmic movements for 1-3 seconds. Thus, the muscle will relax and the fibers around the muscle will be stimulated. Mechanical stimulation given with the Helfer Skin Tap technique during intramuscular vaccine administration will distract the baby's attention. | Procedure or surgery | Helfer Skin Tap Technique group |
| ShotBlocker Technique groupThe protruding but not sharp surface on the ShotBlocker tool will be placed on the baby's skin before intramuscular vaccine administration. Injection will be applied to the middle part of this vehicle, which has a 'U' appearance. This tool, which does not cause any harm to the skin surface, will provide stimulation to the muscle fibers according to the Gate Control Theory related to pain. | Procedure or surgery | ShotBlocker Technique group |
Primary outcome
Neonatal Infant Pain Scale = NIPS
Time frame: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).
The Newborn-Infant Pain Scale, developed by Lawrence et al. (1993) to evaluate the physiological and behavioral responses of newborns to pain, was adapted into Turkish by Akdovan (1999). Scale; It consists of five behavioral and one physiological parts, including facial expression, crying, breathing pattern, arm and leg movements, and sleep-wake state. The crying part of the scale is given 0-1 and 2 points, and the other parts are given 0-1 point. The total score can range from 0 to 7, and a score higher than 3 indicates greater pain intensity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Helfer Skin Tap Technique group and ShotBlocker Technique group in people with Pain, run by Ondokuz Mayıs 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale = NIPS (time frame: Immediately after vaccination, the baby's pain will be evaluated with the Newborn Infant Pain Scale (NIPS).). 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 7 Feb 2024.