PainNCT07749235
The Effect of the Helfer Skin Tap and Buzzy Application on Vaccination Pain, Fear and Crying Duration
A study testing Bee Buzzy and Helfer Skin TAp in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
To minimize the pain and discomfort during vaccination, one of three different methods will be used. One method involves using 'Buzzy,' a small, bee-shaped device that provides vibration and a cooling sensation; another involves massaging the injection site by tapping it rhythmically with our fingertips; and the third… Read more about this study
- Who is it for?
- Ages 9 to 12 months
- What is being tested?
- Bee Buzzy and Helfer Skin TAp
- Type of treatment
- Vaccines, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2026to 29 May 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 9 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth between the 38th and 42nd weeks of gestation
- Having completed the 9th month postpartum
- Being followed under the standard immunization program in accordance with the national vaccination schedule.
- Babies of mothers who can speak and understand Turkish
Who cannot join
- Having an acute or chronic illness
- Having a history of allergies
- Presence of nerve damage or limb deformity at the injection site
- Having received analgesic treatment within the 24 hours prior to immunization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Private Medicana Bursa Hospital
Bursa, Nilüfer
About this study
To minimize the pain and discomfort during vaccination, one of three different methods will be used. One method involves using 'Buzzy,' a small, bee-shaped device that provides vibration and a cooling sensation; another involves massaging the injection site by tapping it rhythmically with our fingertips; and the third follows the standard vaccination procedure. Participants will be randomly assigned to the group.
- Being tested
- Bee Buzzy, Helfer Skin TAp
- Keywords
- infant, vaccination, pain, fear, crying
- Medical subject headings
- Pain, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee BuzzyDevice
Buzzy the Bee will be attached to the leg where the 9-month-old infant-included in this group by the researcher-is to receive the vaccine. Thanks to its cold wings and vibration, Buzzy the Bee reduces pain; it helps distract attention during the vaccination process, thereby alleviating feelings of pain and fear. Buzzy the Bee will be secured 5 cm above the injection site, and the nurse will administer the vaccine after a 15-second wait.
Helfer Skin TApBehavioural
HST technique maneuvers will be applied to the 9-month-old infants in this group during vaccination. HST consists of a four-stage tapping sequence. The administering nurse will perform approximately 10 taps over a 5-second period using the palmar surface of the dominant hand's fingers to relax the leg muscles at the injection site (Stage 1). Following skin disinfection, the nurse will position the thumb and index finger of the non-dominant hand in a V-shape and perform 3 taps on the injection site using the palmar surface of those fingers (Stage 2). Simultaneously with the third tap, the nurse will insert the needle into the muscle at a 90-degree angle while continuing to tap the skin lightly with the palmar surface of the non-dominant hand's fingers (Stage 3). Once the medication has been fully administered, the nurse will perform 3 taps on the skin with the palmar surface of the non-dominant hand's fingers and withdraw the needle simultaneously with the final tap (Stage 4).
| Study group | Role | What they receive |
|---|---|---|
| Bee Buzzy | Experimental | Buzzy the Bee will be used on the patient during the 9-month vaccination procedure. Thanks to its cold wings and vibration, Buzzy reduces pain and helps distract the patient during the injection, thereby alleviating feelings of pain and fear. Buzzy will be placed 5 cm above the injection site; after a 15-second wait, the actual vaccination will be administered. Receives: Device: Bee Buzzy |
| Helfer Skin Tap (HST) Technique Group: | Experimental | HST technique maneuvers will be applied to the 9-month-old infants in this group during vaccination. HST consists of a four-stage tapping sequence. The administering nurse will perform approximately 10 taps over a 5-second period using the palmar surface of the dominant hand's fingers to relax the leg muscles at the injection site (Stage 1). Following skin disinfection, the nurse will position the thumb and index finger of the non-dominant hand in a V-shape and perform 3 taps on the injection site using the palmar surface of those fingers (Stage 2). Simultaneously with the third tap, the nurse will insert the needle into the muscle at a 90-degree angle while continuing to tap the skin lightly with the palmar surface of the non-dominant hand's fingers (Stage 3). Once the medication has been fully administered, the nurse will perform 3 taps on the skin with the palmar surface of the non-dominant hand's fingers and withdraw the needle simultaneously with the final tap (Stage 4). Receives: Behavioral: Helfer Skin TAp |
| control group | No intervention | No intervention other than the administration of the vaccine by the nurse will be performed on the 9-month-old infant in this group. The 9-month-old infant will receive routine vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale
The Fear Facial Expression Scale was adapted for adults as "The Faces Anxiety Scale" by McKinley et al. (2003). The same scale was subsequently adapted for pediatric medical contexts as the "Children's Fear Scale" by McMurtry et al. (2011). This scale features five distinct facial expressions. It is scored on a scale of 0 to 4 and is recognized as a reliable and valid measurement tool for assessing fear. A study on its Turkish validity and reliability, conducted by Binay Yaz and Bal Yılmaz (2019), demonstrated that the scale is a reliable instrument for measuring fear of medical treatment and surgical procedures across all pediatric age groups.
Measured: Periprocedural
Wong-Baker Faces Pain Rating Scale-WBFPRS
It is the most frequently used scale for pain assessment in pediatric patients because it has been reported to effectively differentiate pain levels across all age groups of children. Six (6) facial expressions, rated from 0 to 10 based on the presence and severity of pain, are utilized. The facial expressions are categorized as follows: "0" (smiling/no pain), 1-2 ("hurts a little"), 3-4 ("hurts a little more"), 5-6 ("hurts even more"), 7-8 ("hurts a lot"), and 9-10 ("hurts the most"). This scale does not require verbal expression or numerical values and serves as a reliable and valid measurement tool for assessing acute pain.
Measured: Periprocedural
Crying Duration
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start27 Jul 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion29 May 2027 (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 Ege 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Torun, Ege University
- Investigators
- Hatice BAL, Prof. Dr., Study director, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749235
- Sponsor's protocol ID
- 26-2T/75
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Helfer Skin Tap and Buzzy Application on Vaccination Pain, Fear and Crying Duration
- ClinicalTrials.gov ID
- NCT07749235
- Acronym / sponsor ID
- 26-2T/75
- Keywords
- infant, vaccination, pain, fear, crying
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 May 2027 (estimated)
- First posted
- 6 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.
To minimize the pain and discomfort during vaccination, one of three different methods will be used. One method involves using 'Buzzy,' a small, bee-shaped device that provides vibration and a cooling sensation; another involves massaging the injection site by tapping it rhythmically with our fingertips; and the third follows the standard vaccination procedure. Participants will be randomly assigned to the group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bee Buzzy | Experimental | Device: Bee BuzzyBuzzy the Bee will be used on the patient during the 9-month vaccination procedure. Thanks to its cold wings and vibration, Buzzy reduces pain and helps distract the patient during the injection, thereby alleviating feelings of pain and fear. Buzzy will be placed 5 cm above the injection site; after a 15-second wait, the actual vaccination will be administered. |
| Helfer Skin Tap (HST) Technique Group: | Experimental | Behavioral: Helfer Skin TApHST technique maneuvers will be applied to the 9-month-old infants in this group during vaccination. HST consists of a four-stage tapping sequence. The administering nurse will perform approximately 10 taps over a 5-second period using the palmar surface of the dominant hand's fingers to relax the leg muscles at the injection site (Stage 1). Following skin disinfection, the nurse will position the thumb and index finger of the non-dominant hand in a V-shape and perform 3 taps on the injection site using the palmar surface of those fingers (Stage 2). Simultaneously with the third tap, the nurse will insert the needle into the muscle at a 90-degree angle while continuing to tap the skin lightly with the palmar surface of the non-dominant hand's fingers (Stage 3). Once the medication has been fully administered, the nurse will perform 3 taps on the skin with the palmar surface of the non-dominant hand's fingers and withdraw the needle simultaneously with the final tap (Stage 4). |
| control group | No intervention | –No intervention other than the administration of the vaccine by the nurse will be performed on the 9-month-old infant in this group. The 9-month-old infant will receive routine vaccination. |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth between the 38th and 42nd weeks of gestation
- Having completed the 9th month postpartum
- Being followed under the standard immunization program in accordance with the national vaccination schedule.
- Babies of mothers who can speak and understand Turkish
Key exclusion criteria (4 listed)
- Having an acute or chronic illness
- Having a history of allergies
- Presence of nerve damage or limb deformity at the injection site
- Having received analgesic treatment within the 24 hours prior to immunization
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 |
|---|---|---|
| Bee BuzzyBuzzy the Bee will be attached to the leg where the 9-month-old infant-included in this group by the researcher-is to receive the vaccine. Thanks to its cold wings and vibration, Buzzy the Bee reduces pain; it helps distract attention during the vaccination process, thereby alleviating feelings of pain and fear. Buzzy the Bee will be secured 5 cm above the injection site, and the nurse will administer the vaccine after a 15-second wait. | Device | Bee Buzzy |
| Helfer Skin TApHST technique maneuvers will be applied to the 9-month-old infants in this group during vaccination. HST consists of a four-stage tapping sequence. The administering nurse will perform approximately 10 taps over a 5-second period using the palmar surface of the dominant hand's fingers to relax the leg muscles at the injection site (Stage 1). Following skin disinfection, the nurse will position the thumb and index finger of the non-dominant hand in a V-shape and perform 3 taps on the injection site using the palmar surface of those fingers (Stage 2). Simultaneously with the third tap, the nurse will insert the needle into the muscle at a 90-degree angle while continuing to tap the skin lightly with the palmar surface of the non-dominant hand's fingers (Stage 3). Once the medication has been fully administered, the nurse will perform 3 taps on the skin with the palmar surface of the non-dominant hand's fingers and withdraw the needle simultaneously with the final tap (Stage 4). | Behavioural | Helfer Skin Tap (HST) Technique Group: |
Primary outcome
Children's Fear Scale
Time frame: Periprocedural
The Fear Facial Expression Scale was adapted for adults as "The Faces Anxiety Scale" by McKinley et al. (2003). The same scale was subsequently adapted for pediatric medical contexts as the "Children's Fear Scale" by McMurtry et al. (2011). This scale features five distinct facial expressions. It is scored on a scale of 0 to 4 and is recognized as a reliable and valid measurement tool for assessing fear. A study on its Turkish validity and reliability, conducted by Binay Yaz and Bal Yılmaz (2019), demonstrated that the scale is a reliable instrument for measuring fear of medical treatment and surgical procedures across all pediatric age groups.
Wong-Baker Faces Pain Rating Scale-WBFPRS
Time frame: Periprocedural
It is the most frequently used scale for pain assessment in pediatric patients because it has been reported to effectively differentiate pain levels across all age groups of children. Six (6) facial expressions, rated from 0 to 10 based on the presence and severity of pain, are utilized. The facial expressions are categorized as follows: "0" (smiling/no pain), 1-2 ("hurts a little"), 3-4 ("hurts a little more"), 5-6 ("hurts even more"), 7-8 ("hurts a lot"), and 9-10 ("hurts the most"). This scale does not require verbal expression or numerical values and serves as a reliable and valid measurement tool for assessing acute pain.
Crying Duration
Time frame: Periprocedural
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 6 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Hatice BAL, Prof. Dr. study director
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bee Buzzy and Helfer Skin TAp in people with Pain and Fear, run by Ege University at 1 site in Turkey (Türkiye).
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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Children's Fear Scale (time frame: Periprocedural). The study lists 3 primary outcomes in all. 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 6 Aug 2026.