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

NCT07650591 | Not Yet Recruiting

• 1 other identifier: TBAEK-397
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief 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?
• 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.
• 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

Outcome Measures

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.

  Immediately after the venipuncture procedure (single assessment, within ~1 minute)

Secondary Outcomes (1)

• Procedural fear during the blood-draw procedure (Children's Fear Scale)

  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.

Study Arms (3)

Rhythmic Skin Tapping

EXPERIMENTAL

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

Behavioral: Rhythmic Skin Tapping

Internal Vibration (Humming)

EXPERIMENTAL

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

Behavioral: Internal Vibration (Humming)

Control

NO INTERVENTION

Interventions

Rhythmic Skin Tapping BEHAVIORAL

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

Rhythmic Skin Tapping

Internal Vibration (Humming) BEHAVIORAL

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

Internal Vibration (Humming)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

MeSH Terms

Conditions

Pain, Procedural; Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Mustafa Volkan DÜZGÜN, PhD

CONTACT

+905079967991; mvolkanduzgun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share