Procedural PainNCT07650591
THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE
A study testing Rhythmic Skin Tapping and Internal Vibration (Humming) in people with Procedural Pain and Acute Pain, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
What is this study about, in short? This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested: A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Pain, Acute Pain, Needle-Related Pain and Distress
- What is being tested?
- Rhythmic Skin Tapping and Internal Vibration (Humming)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to Jun 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 6 and 12 years of age
- Requiring a peripheral venipuncture procedure
- Having written informed consent from the parents
- Having verbal assent from the child
- Being able to speak and understand Turkish
- Having a cognitive development level appropriate for age
- Absence of any chronic pain condition
Who cannot join
- Refusing to participate in the study or wishing to withdraw at any stage
- Development of complications during the procedure
- Having used analgesics within the last 24 hours
- Having previously participated in the same study
- Impaired skin integrity at the procedure site
- Having a neurological or psychiatric diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kepez State Hospital
Antalya, Kepez, 07070
M.Volkan DÜZGÜN, 05079967991, mvolkanduzgun@gmail.com
About this study
Official title: THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE: A RANDOMİZED CONTROLLED TRİAL
What is this study about, in short?
This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested:
Read more
- A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go ("rhythmic skin tapping").
- The child making an "mmmm" humming sound while the blood is being drawn ("internal vibration" or "humming").
These methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method.
Why is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children.
Some methods used to reduce pain have practical limits:
- Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost.
- Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene.
For these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that.
How do the methods work? (Simple science) Both methods rest on an idea called the "Gate Control Theory": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a "gate" that partly blocks the pain signal from reaching the brain.
- Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help "close the gate," so the pain is felt less.
- Internal vibration (humming): The "mmmm" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control.
Who can take part in the study?
Can take part:
- Children aged 6-12 years
- Children who will have a blood draw
- Children whose parent has given written permission and who themselves agree verbally
- Children who can understand and speak Turkish
- Children whose cognitive development is appropriate for their age
- Children who do not have an ongoing (chronic) pain condition
Cannot take part, or will be withdrawn:
- Children who do not want to take part, or wish to withdraw at any stage
- Children who develop a complication (an unexpected medical problem) during the procedure
- Children who have used a painkiller within the last 24 hours
- Children who have already taken part in this study before
- Children whose skin is broken at the site where the needle will go
- Children who have a neurological or psychiatric diagnosis
What will happen if my child takes part?
The blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step:
- Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called "randomization" and it keeps the comparison fair.
- The blood draw is done as usual. The only difference is the method used, depending on your child's group.
- Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4).
- A short form collects details such as age, sex, and any previous blood-draw experience.
- No extra needle, medicine, or laboratory test is done beyond the routine blood draw.
The three groups are:
Group What is done in this group?
- Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site.
- Internal vibration (humming) The child is asked to make an "mmmm" humming sound during the blood draw.
- Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods.
Where and when will the study take place?
- Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye).
- Data collection period: June 2026 - June 2027. The total study duration is about 12 months.
- Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable.
Taking part is completely voluntary
- Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason.
- Not taking part, or withdrawing, will not affect the health care your child receives in any way.
- Your child may also say they do not want the method; the child's decision is
- Conditions
- Procedural Pain, Acute Pain, Needle-Related Pain and Distress, Fear, Anxiety, Phlebotomy
- Being tested
- Rhythmic Skin Tapping, Internal Vibration (Humming)
- Medical subject headings
- Pain, Procedural, Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Skin TappingBehavioural
Rhythmic tapping with the fingertips will be applied proximal to the procedure site.
Internal Vibration (Humming)Behavioural
The child will be asked to make an "mmmm" sound during the venipuncture procedure.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Skin Tapping | Experimental | Rhythmic tapping with the fingertips will be applied proximal to the procedure site. Receives: Behavioral: Rhythmic Skin Tapping |
| Internal Vibration (Humming) | Experimental | The child will be asked to make an "mmmm" sound during the venipuncture procedure. Receives: Behavioral: Internal Vibration (Humming) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during the blood-draw procedure (Wong-Baker FACES Pain Rating Scale)
Self-reported pain intensity assessed with the Wong-Baker FACES Pain Rating Scale, scored 0-10 (0 = no pain, 10 = worst pain). Higher scores indicate greater pain. Assessed once, immediately after the procedure.
Measured: Immediately after the venipuncture procedure (single assessment, within ~1 minute)
Secondary outcomes (1)
Procedural fear during the blood-draw procedure (Children's Fear Scale)
Immediately after the venipuncture procedure (single assessment, within ~1 minute)
Measured: Fear level assessed with the Children's Fear Scale (CFS), a single-item 5-face visual scale scored 0-4 (0 = no fear, 4 = severe fear). Higher scores indicate greater fear. Assessed once, immediately 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 posted16 Jun 2026
- Study start1 Jul 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 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.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Volkan DÜZGÜN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650591
- Sponsor's protocol ID
- TBAEK-397
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2026
- Last updated
- 19 Aug 2026
- 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 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE: A RANDOMİZED CONTROLLED TRİAL
- ClinicalTrials.gov ID
- NCT07650591
- Acronym / sponsor ID
- TBAEK-397
- Conditions
- Procedural Pain, Acute Pain, Needle-Related Pain and Distress, Fear, Anxiety, Phlebotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 16 Jun 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.
What is this study about, in short?
This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested:
- A nurse lightly and rhythmically tapping with their fingertips just above the spot where the needle will go ("rhythmic skin tapping").
- The child making an "mmmm" humming sound while the blood is being drawn ("internal vibration" or "humming").
These methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method.
Why is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children.
Some methods used to reduce pain have practical limits:
- Numbing creams must be applied 30-60 minutes before the procedure; they are not practical in urgent situations and add cost.
- Special devices that give cold and vibration can work, but they can be expensive, are not always available, and need care for hygiene.
For these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that.
How do the methods work? (Simple science) Both methods rest on an idea called the "Gate Control Theory": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a "gate" that partly blocks the pain signal from reaching the brain.
- Rhythmic skin tapping: Gentle, rhythmic tapping with the fingers may help "close the gate," so the pain is felt less.
- Internal vibration (humming): The "mmmm" sound creates a mild vibration in the body. It can also stimulate the calming part of the nervous system, which may lower the heart rate and stress. Taking an active part in the procedure also gives the child a sense of control.
Who can take part in the study?
Can take part:
- Children aged 6-12 years
- Children who will have a blood draw
- Children whose parent has given written permission and who themselves agree verbally
- Children who can understand and speak Turkish
- Children whose cognitive development is appropriate for their age
- Children who do not have an ongoing (chronic) pain condition
Cannot take part, or will be withdrawn:
- Children who do not want to take part, or wish to withdraw at any stage
- Children who develop a complication (an unexpected medical problem) during the procedure
- Children who have used a painkiller within the last 24 hours
- Children who have already taken part in this study before
- Children whose skin is broken at the site where the needle will go
- Children who have a neurological or psychiatric diagnosis
What will happen if my child takes part?
The blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step:
- Your child is placed by computer, at random (like drawing lots), into one of three groups. No one can choose the group in advance; this is called "randomization" and it keeps the comparison fair.
- The blood draw is done as usual. The only difference is the method used, depending on your child's group.
- Right after the procedure, the child is shown two short picture scales: one for pain, with faces ranging from smiling to crying (0-10), and one for fear, also made of faces (0-4).
- A short form collects details such as age, sex, and any previous blood-draw experience.
- No extra needle, medicine, or laboratory test is done beyond the routine blood draw.
The three groups are:
Group What is done in this group?
- Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site.
- Internal vibration (humming) The child is asked to make an "mmmm" humming sound during the blood draw.
- Control group The blood draw is done as usual, with no extra method. This group is the comparison point used to measure the effect of the other two methods.
Where and when will the study take place?
- Place: Kepez State Hospital Blood Collection Outpatient Clinic (Antalya, Türkiye).
- Data collection period: June 2026 - June 2027. The total study duration is about 12 months.
- Planned number of participants: 126 children in total (42 in each group). This number was set in advance by a statistical calculation so the results would be reliable.
Taking part is completely voluntary
- Your child does not have to take part. Even if you agree, you may withdraw at any time without giving a reason.
- Not taking part, or withdrawing, will not affect the health care your child receives in any way.
- Your child may also say they do not want the method; the child's decision is
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Skin Tapping | Experimental | Behavioral: Rhythmic Skin TappingRhythmic tapping with the fingertips will be applied proximal to the procedure site. |
| Internal Vibration (Humming) | Experimental | Behavioral: Internal Vibration (Humming)The child will be asked to make an "mmmm" sound during the venipuncture procedure. |
| Control | No intervention | – |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being between 6 and 12 years of age
- Requiring a peripheral venipuncture procedure
- Having written informed consent from the parents
- Having verbal assent from the child
- Being able to speak and understand Turkish
Key exclusion criteria (6 listed)
- Refusing to participate in the study or wishing to withdraw at any stage
- Development of complications during the procedure
- Having used analgesics within the last 24 hours
- Having previously participated in the same study
- Impaired skin integrity at the procedure site
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 |
|---|---|---|
| Rhythmic Skin TappingRhythmic tapping with the fingertips will be applied proximal to the procedure site. | Behavioural | Rhythmic Skin Tapping |
| Internal Vibration (Humming)The child will be asked to make an "mmmm" sound during the venipuncture procedure. | Behavioural | Internal Vibration (Humming) |
Primary outcome
Pain intensity during the blood-draw procedure (Wong-Baker FACES Pain Rating Scale)
Time frame: Immediately after the venipuncture procedure (single assessment, within ~1 minute)
Self-reported pain intensity assessed with the Wong-Baker FACES Pain Rating Scale, scored 0-10 (0 = no pain, 10 = worst pain). Higher scores indicate greater pain. Assessed once, immediately after the procedure.
1 secondary outcome
Procedural fear during the blood-draw procedure (Children's Fear Scale)
Time frame: Fear level assessed with the Children's Fear Scale (CFS), a single-item 5-face visual scale scored 0-4 (0 = no fear, 4 = severe fear). Higher scores indicate greater fear. Assessed once, immediately after the procedure.
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 19 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Skin Tapping and Internal Vibration (Humming) in people with Procedural Pain and Acute Pain, run by Akdeniz 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 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?
Contact Mustafa Volkan DÜZGÜN, PhD (+905079967991, mvolkanduzgun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during the blood-draw procedure (Wong-Baker FACES Pain Rating Scale) (time frame: Immediately after the venipuncture procedure (single assessment, within ~1 minute)). 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 19 Aug 2026.