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

June 12, 2026 updated by: Mustafa Volkan DÜZGÜN, Akdeniz University

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:

  • 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Experimental: Rhythmic Skin Tapping
Rhythmic tapping with the fingertips will be applied proximal to the procedure site.
Behavioral: Rhythmic Skin Tapping
Rhythmic tapping with the fingertips will be applied proximal to the procedure site.
Experimental: Internal Vibration (Humming)
The child will be asked to make an "mmmm" sound during the venipuncture procedure.
Behavioral: Internal Vibration (Humming)
The child will be asked to make an "mmmm" sound during the venipuncture procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the venipuncture procedure (single assessment, within ~1 minute)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Immediately after the venipuncture procedure (single assessment, within ~1 minute)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TBAEK-397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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