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

2026年8月18日 更新者: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

調査の概要

研究の種類

介入

入学 (推定)

126

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

はい

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
介入なし:コントロール
実験的:Rhythmic Skin Tapping
Rhythmic tapping with the fingertips will be applied proximal to the procedure site.
Rhythmic tapping with the fingertips will be applied proximal to the procedure site.
実験的:Internal Vibration (Humming)
The child will be asked to make an "mmmm" sound during the venipuncture procedure.
The child will be asked to make an "mmmm" sound during the venipuncture procedure.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Pain intensity during the blood-draw procedure (Wong-Baker FACES Pain Rating Scale)
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Procedural fear during the blood-draw procedure (Children's Fear Scale)
時間枠: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.

協力者と研究者

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年7月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年6月1日

試験登録日

最初に提出

2026年6月9日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月19日

QC基準を満たした最後の更新が送信されました

2026年8月18日

最終確認日

2026年8月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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