ClinicalTrials.gg
RecruitingNCT07650591Updated Aug 19, 2026

THE EFFECT OF 'RHYTHMİC SKİN TAPPİNG' AND INTERNAL VİBRATİON APPLİED PROXİMAL TO THE PROCEDURE SİTE ON PAİN AND FEAR PERCEPTİON DURİNG PEDİATRİC PERİPHERAL VENİPUNCTURE

An interventional study of Rhythmic Skin Tapping and Internal Vibration (Humming) in Procedural Pain, Acute Pain and Needle-Related Pain and Distress, sponsored by Akdeniz University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.

Sponsored by Akdeniz University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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 ("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?

  1. Rhythmic skin tapping Gentle, rhythmic tapping with the fingertips just above the needle site.
  2. Internal vibration (humming) The child is asked to make an "mmmm" humming sound during the blood draw.
  3. 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
02

Conditions studied

  • Procedural Pain
  • Acute Pain
  • Needle-Related Pain and Distress
  • Fear
  • Anxiety
  • Phlebotomy
03

In context

Pain, Procedural

241 studies on the registry are indexed under Pain, Procedural; 64 are open to participants now.

This study's planned enrollment of 126 is above the median of 90 across 227 interventional studies indexed under Pain, Procedural.

Browse Pain, Procedural studies →

Lead sponsor

Akdeniz University is the lead sponsor of 297 studies on the registry; 62 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between 6 and 12 years of age

Requiring a peripheral venipuncture procedure

Having written 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

Exclusion criteria

Exclusion Criteria:

  • 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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    Rhythmic Skin Tapping

    Rhythmic tapping with the fingertips will be applied proximal to the procedure site.

    Behavioral: Rhythmic Skin Tapping

  • Experimental
    Internal Vibration (Humming)

    The child will be asked to make an "mmmm" sound during the venipuncture procedure.

    Behavioral: Internal Vibration (Humming)

  • No intervention
    Control

Interventions

  • BehavioralRhythmic Skin Tapping

    Rhythmic tapping with the fingertips will be applied proximal to the procedure site.

  • BehavioralInternal Vibration (Humming)

    The child will be asked to make an "mmmm" sound during the venipuncture procedure.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

    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.

07

Study locations

1 of 1 sites recruiting
  • Kepez State Hospital
    Antalya, Kepez 07070, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07650591
Lead sponsor
Akdeniz University
Responsible party
Mustafa Volkan DÜZGÜN (Principal Investigator, Akdeniz University) — Principal investigator
First posted
Jun 16, 2026
Start date
Jul 1, 2026
Primary completion
May 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Aug 19, 2026

Study contacts

Mustafa Volkan DÜZGÜN, PhD
Contact
mvolkanduzgun@gmail.com
+905079967991

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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