Health Knowledge, Attitudes, PracticeNCT07185152
The Effect of Mechanical Vibration and Flick Tapping Methods in Reducing Pain in Infant Vaccination
A study testing mechanical vibration and Flick tapping in people with Health Knowledge, Attitudes, Practice and Health Behavior, run by Berrin GOGER at 1 site in Turkey (Türkiye).
Trial summary
A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time. Read more about this study
- Who is it for?
- Ages 30 to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Health Behavior
- What is being tested?
- mechanical vibration and Flick tapping
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Apr 2024to 22 Apr 2025
- 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 30 to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Mothers agreeing to participate in the study,
- The baby's gestational age being between 38 and 42 weeks,
- Babies being 30-42 days old after birth,
- The baby's birth weight being between 2500 g and 4000 g
- The infant has not been given pain medication prior to vaccination and has a normal body temperature.
Who cannot join
- Araştırmaya katılmayı kabul etmeyen anneler,
- Gestasyonel yaşı 38. haftanın altında 42. haftanın üzerinde olan bebekler,
- Konjenital hastalık veya doğumsal anomalisi olan bebekler olarak belirlendi.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kelkit No. 1 Family Health Center
Gümüşhane, 29600
About this study
Official title: The Effect of Mechanical Vibration and Flick Tapping Methods in Reducing Pain During Hepatitis B Vaccine Administration in Infants
A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time.
Flicking the injection site can be used to control pain in childhood. To date, only one experimental study testing the flick method has reported that the flick method applied before intramuscular injection had lower pain scores in babies during and after vaccination.
Studies show that the positive effects of both methods are mentioned. However, no study has been found to examine the effects of both methods on injection pain that may occur when the second dose of Hepatitis B vaccine is administered in the neonatal period and compare their effects. The fact that the effects of mechanical vibration and flicking methods as pain relief strategies on reducing pain, physiological parameters and crying duration have not been examined in this population before shows the deficiency in the literature.This study aimed to examine the effect of flicking the injection site before the second dose of the Hepatitis B vaccine applied to the anterior surface of the vastus lateralis muscle in infancy and applying mechanical vibration to the injection site throughout the vaccination procedure on acute pain, crying duration and physiological parameters that may occur due to intramuscular injection.
Read the detailed description
Most tactile stimuli, such as vibration, have the potential to reduce pain because many large fibers are present in the skin. It is stated that mechanical vibration works primarily by turning off the ascending transmission of the nociceptive afferent nerve signal in the spinal-thalamic pathway and may provide an alternative or additional pain relief method for acute, short-term pain in newborns.
A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time.
The use of hands is the oldest known and universal method for relieving pain. Methods such as manual pressure application (similar to the flick method) are used to reduce pain during invasive procedures.
Manual methods can be incorporated into clinical practice without additional cost or time. Experimental and clinical studies have suggested that various types of manual stimulation of certain nerve fibers (manipulations such as rubbing, applying pressure, and tapping just above or below painful areas) followed by the release of beta-endorphin into the bloodstream relieves pain.
Flicking the injection site can be used to control pain in childhood. To date, only one experimental study testing the flick method has reported that the flick method applied before intramuscular injection had lower pain scores in babies during and after vaccination.
Studies show that the positive effects of both methods are mentioned. However, no study has been found to examine the effects of both methods on injection pain that may occur when the second dose of Hepatitis B vaccine is administered in the neonatal period and compare their effects. The fact that the effects of mechanical vibration and flicking methods as pain relief strategies on reducing pain, physiological parameters and crying duration have not been examined in this population before shows the deficiency in the literature. This study will be the first to examine the effectiveness of vibration analgesia with the flick method in intramuscular injection pain in the newborn baby population in the same sample group and to compare the analgesic effectiveness of both methods.
In line with all this information, this study aimed to examine the effect of flicking the injection site before the second dose of the Hepatitis B vaccine applied to the anterior surface of the vastus lateralis muscle in infancy and applying mechanical vibration to the injection site throughout the vaccination procedure on acute pain, crying duration and physiological parameters that may occur due to intramuscular injection.
- Being tested
- mechanical vibration, Flick tapping
- Keywords
- Infant, Pain, Pediatric nursing, Vaccines, Vibration
- Medical subject headings
- Behavior, Health Behavior, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical vibrationOther
Mechanical vibration was applied to babies randomized to the mechanical vibration group before and during the vaccination procedure.
Flick tappingOther
Before the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Vibration group | Experimental | Babies randomized to the Mechanical Vibration group were subjected to vibration approximately 1 cm above the injection site with a mechanical vibration device before and during the vaccination procedure. Receives: Other: mechanical vibration |
| Flick tapping group | Experimental | Before the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger. Receives: Other: Flick tapping |
| Control groups | No intervention | The routine vaccination procedure was administered to the infants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn infant pain assessment
Before, during, and after the procedure, infants' behavioral responses to pain were recorded using NIPS.
Measured: The behavioral states of the infants were recorded with NIPS one minute before the procedure. The infants' responses to the pain they felt during the procedure were recorded with NIPS during the procedure. The infants' behavioral responses to pain after
body temperature measurement
Body temperature was measured before and after the procedure.
Measured: Body temperature was measured one minute before the procedure. Body temperature was measured one minute after the procedure.
respiratory rate measurement
The infants' respiratory rate was measured before and after the procedure.
Measured: Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.
Oxygen saturation measured
Oxygen saturation was measured before, during, and after the procedure.
Measured: Oxygen saturation was measured one minute before the procedure, during the procedure, and for one minute after the procedure.
heart rate measured
Heart rate was measured before, during, and after the procedure.
Measured: Heart rate was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.
Crying duration measurement
The crying time was measured for one minute after the procedure.
Measured: With the start of the vaccination process, the crying duration was recorded on the Newborn Observation Form for one minute. The start of the procedure and the crying duration were recorded for one minute.
Secondary outcomes (5)
Newborn infant pain assessment
The infants' behavioral responses to pain were recorded before the procedure. During the procedure, the infants' behavioral responses to pain were recorded using NIPS. After the procedure, the infants' behavioral responses to pain were recorded using NIPS. Pain was rated on a scale of 0 (no pain) to 7 (highest level of pain).
Measured: One minute before the procedure, behavioral responses to pain were recorded using NIPS. During the procedure, behavioral responses to pain were recorded using NIPS. Behavioral responses to pain were recorded using NIPS for one minute after the procedure.
Body temperature measured.
Body temperature was measured before and after the procedure.
Measured: Body temperature was measured one minute before and one minute after the procedure.
Respiratory rate measured
The infants' respiratory rate was measured before and after the procedure.
Measured: Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.
oxygen saturation measured
Oxygen saturation was measured before, during, and after the procedure.
Measured: Oxygen saturation was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.
Heart rate measured
Heart rate was measured before, during, and after the procedure.
Measured: Heart rate was measured one minute before the procedure, during the procedure, and for one minute after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start29 Apr 2024
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 3 groups in the randomized controlled experimental study. Mechanical vibration method was applied to one group, flick tapping method was applied to one group, and one group was included in the study as a control group without any intervention.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berrin GOGER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Berrin GOGER, Gümüşhane Universıty
- Investigators
- BERRİN GÖGER, LECTURER, Principal investigator, GU, KSDHSV School, Department of Medical Services and Techniques, Gümüşhane, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07185152
- Sponsor's protocol ID
- E-95674917-108.99-245388
- Other IDs
- TDK-2024-15853
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No. There are no plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mechanical Vibration and Flick Tapping Methods in Reducing Pain During Hepatitis B Vaccine Administration in Infants
- ClinicalTrials.gov ID
- NCT07185152
- Acronym / sponsor ID
- E-95674917-108.99-245388
- Keywords
- Infant, Pain, Pediatric nursing, Vaccines, Vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Berrin GOGERUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 22 Sep 2025 (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.
A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time.
Flicking the injection site can be used to control pain in childhood. To date, only one experimental study testing the flick method has reported that the flick method applied before intramuscular injection had lower pain scores in babies during and after vaccination.
Studies show that the positive effects of both methods are mentioned. However, no study has been found to examine the effects of both methods on injection pain that may occur when the second dose of Hepatitis B vaccine is administered in the neonatal period and compare their effects. The fact that the effects of mechanical vibration and flicking methods as pain relief strategies on reducing pain, physiological parameters and crying duration have not been examined in this population before shows the deficiency in the literature.This study aimed to examine the effect of flicking the injection site before the second dose of the Hepatitis B vaccine applied to the anterior surface of the vastus lateralis muscle in infancy and applying mechanical vibration to the injection site throughout the vaccination procedure on acute pain, crying duration and physiological parameters that may occur due to intramuscular injection.
Detailed description
Most tactile stimuli, such as vibration, have the potential to reduce pain because many large fibers are present in the skin. It is stated that mechanical vibration works primarily by turning off the ascending transmission of the nociceptive afferent nerve signal in the spinal-thalamic pathway and may provide an alternative or additional pain relief method for acute, short-term pain in newborns.
A research protocol examining the effect of vibration on the crying duration variable in needle-related medical procedures in newborns also predicted that vibration therapy would be effective in reducing pain caused by vaccine injection and shortening the newborn's crying time.
The use of hands is the oldest known and universal method for relieving pain. Methods such as manual pressure application (similar to the flick method) are used to reduce pain during invasive procedures.
Manual methods can be incorporated into clinical practice without additional cost or time. Experimental and clinical studies have suggested that various types of manual stimulation of certain nerve fibers (manipulations such as rubbing, applying pressure, and tapping just above or below painful areas) followed by the release of beta-endorphin into the bloodstream relieves pain.
Flicking the injection site can be used to control pain in childhood. To date, only one experimental study testing the flick method has reported that the flick method applied before intramuscular injection had lower pain scores in babies during and after vaccination.
Studies show that the positive effects of both methods are mentioned. However, no study has been found to examine the effects of both methods on injection pain that may occur when the second dose of Hepatitis B vaccine is administered in the neonatal period and compare their effects. The fact that the effects of mechanical vibration and flicking methods as pain relief strategies on reducing pain, physiological parameters and crying duration have not been examined in this population before shows the deficiency in the literature. This study will be the first to examine the effectiveness of vibration analgesia with the flick method in intramuscular injection pain in the newborn baby population in the same sample group and to compare the analgesic effectiveness of both methods.
In line with all this information, this study aimed to examine the effect of flicking the injection site before the second dose of the Hepatitis B vaccine applied to the anterior surface of the vastus lateralis muscle in infancy and applying mechanical vibration to the injection site throughout the vaccination procedure on acute pain, crying duration and physiological parameters that may occur due to intramuscular injection.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- There are 3 groups in the randomized controlled experimental study. Mechanical vibration method was applied to one group, flick tapping method was applied to one group, and one group was included in the study as a control group without any intervention.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Vibration group | Experimental | Other: mechanical vibrationBabies randomized to the Mechanical Vibration group were subjected to vibration approximately 1 cm above the injection site with a mechanical vibration device before and during the vaccination procedure. |
| Flick tapping group | Experimental | Other: Flick tappingBefore the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger. |
| Control groups | No intervention | –The routine vaccination procedure was administered to the infants in this group. |
Who may qualify
- Ages
- 30 to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Mothers agreeing to participate in the study,
- The baby's gestational age being between 38 and 42 weeks,
- Babies being 30-42 days old after birth,
- The baby's birth weight being between 2500 g and 4000 g
- The infant has not been given pain medication prior to vaccination and has a normal body temperature.
Key exclusion criteria (3 listed)
- Araştırmaya katılmayı kabul etmeyen anneler,
- Gestasyonel yaşı 38. haftanın altında 42. haftanın üzerinde olan bebekler,
- Konjenital hastalık veya doğumsal anomalisi olan bebekler olarak belirlendi.
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 |
|---|---|---|
| mechanical vibrationMechanical vibration was applied to babies randomized to the mechanical vibration group before and during the vaccination procedure. | Other | Mechanical Vibration group |
| Flick tappingBefore the vaccination procedure, the vaccination site was placed on the nail of the middle finger in the babies randomized to the flick tapping group, and then the vaccination was stimulated with a quick tap using the upper nail part of the middle finger. | Other | Flick tapping group |
Primary outcome
Newborn infant pain assessment
Time frame: The behavioral states of the infants were recorded with NIPS one minute before the procedure. The infants' responses to the pain they felt during the procedure were recorded with NIPS during the procedure. The infants' behavioral responses to pain after
Before, during, and after the procedure, infants' behavioral responses to pain were recorded using NIPS.
body temperature measurement
Time frame: Body temperature was measured one minute before the procedure. Body temperature was measured one minute after the procedure.
Body temperature was measured before and after the procedure.
respiratory rate measurement
Time frame: Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.
The infants' respiratory rate was measured before and after the procedure.
Oxygen saturation measured
Time frame: Oxygen saturation was measured one minute before the procedure, during the procedure, and for one minute after the procedure.
Oxygen saturation was measured before, during, and after the procedure.
heart rate measured
Time frame: Heart rate was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.
Heart rate was measured before, during, and after the procedure.
Crying duration measurement
Time frame: With the start of the vaccination process, the crying duration was recorded on the Newborn Observation Form for one minute. The start of the procedure and the crying duration were recorded for one minute.
The crying time was measured for one minute after the procedure.
5 secondary outcomes
Newborn infant pain assessment
Time frame: One minute before the procedure, behavioral responses to pain were recorded using NIPS. During the procedure, behavioral responses to pain were recorded using NIPS. Behavioral responses to pain were recorded using NIPS for one minute after the procedure.
Body temperature measured.
Time frame: Body temperature was measured one minute before and one minute after the procedure.
Respiratory rate measured
Time frame: Respiratory rate was measured for 1 minute before the procedure began. Respiratory rate was measured until the first minute after the procedure.
oxygen saturation measured
Time frame: Oxygen saturation was measured one minute before the procedure, during the procedure, and up to the first minute after the procedure.
Heart rate measured
Time frame: Heart rate was measured one minute before the procedure, during the procedure, and for one minute after the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Principal investigator Berrin GÖGER's institutional affiliation web addressLink provided by the sponsor.
- Principal investigator Berrin GÖGER's institutional affiliation web addressLink provided by the sponsor.
- Individual participant dataSharing planned: No. No. There are no plans to share individual participant data.
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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.
BERRİN GÖGER, LECTURER principal investigator
GU, KSDHSV School, Department of Medical Services and Techniques, Gümüşhane, Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical vibration and Flick tapping in people with Health Knowledge, Attitudes, Practice and Health Behavior, run by Berrin GOGER 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Newborn infant pain assessment (time frame: The behavioral states of the infants were recorded with NIPS one minute before the procedure. The infants' responses to the pain they felt during the procedure were recorded with NIPS during the procedure. The infants' behavioral responses to pain after). The study lists 6 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 22 Sep 2025.