The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Infants During Vaccination

January 9, 2025 updated by: Aynur Aytekin Ozdemir, Istanbul Medeniyet University

The Effect of Mechanical Vibration and Helfer Skin Tap Technique on Procedural Pain in Healthy Infants During Intramuscular Vaccination: a Randomized Controlled Study

This study will be conducted to determine the effect of mechanical vibration and Helfer Skin Tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vaccination is one of the painful procedures routinely performed in infants. The pain experienced by the infant negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family infant interaction. Nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that infants frequently encounter. Mechanical vibration and Helfer skin tap technique are effective methods that can be used in nonpharmacologic procedural pain management.

Studies have commonly used parent-related methods (kangaroo care, mother/ father cuddling, breastfeeding, etc.) for neonatal pain management during vaccine administrations. In units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of needle related acute pain. In addition, no study was found in the literature comparing the effect of mechanical vibration and Helfer skin tap technique on hepatitis B and DTaP-IPV-Hib vaccinations-related pain. This study will be investigated the effects of mechanical vibration and Helfer skin tap technique methods on procedural pain, crying time and duration of the procedure during intramuscular vaccinations in healthy term infants.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • 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 Locations

  • Turkey
    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34720
        • Istanbul Medeniyet University

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy term infants
  • born at 38-42 weeks gestational week,
  • birth weight 2500-4400 g,
  • in stable health,
  • able to carry out vital activities without support,
  • babies ordered third dose Hepatitis B vaccine by the doctor

Exclusion Criteria:

  • with a genetic or congenital anomaly,
  • neurological, cardiological and metabolic diseases,
  • in need of respiratory support,
  • acute or chronic illness that causes pain,
  • a complication of childbirth,
  • nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
The control group will receive routine vaccinations.
Experimental: Mechanical vibration
Mechanical vibration will be used during routine vaccination of infants in this group.
Device: Mechanical vibration
The vibration device will be placed on the procedure site (on the vastus lateralis muscle) on the left extremity and fixed through a long gauze. The vibration device will be operated for 30 seconds with reference to previous studies, then the nurse will administer routine intramuscular Hepatitis B vaccine. A gap of approximately 1-2 cm will be left between the device and the injection site. After the vaccination procedure is completed, the vibration will be terminated. The same procedure was repeated for DTaP-IPV-Hib vaccine administered to the the right extremity. The baby will be swaddled and placed in the mother's lap.
Experimental: Helfer skin tap technique
Helfer skin tap technique will be used during routine vaccinations of infants in this group.
Behavioral: Helfer skin tap technique (HSTT)
In this group, HSTT consisting of 4-stage strokes will be applied to the vaccination site. The nurse will make approximately 10 strokes for 5 seconds with the palmar side of the fingers of the dominant hand to the injection site to relax the muscles (Stage 1). The nurse will give a V-shaped position to the thumb and index finger of the non-dominant hand and give 3 strokes to the injection site with the palmar side of the fingers (Stage 2). The skin entry site of the needle will remain inside the V-shape. Simultaneously with the 3rd stroke, the nurse will insert the needle into the muscle at a 90 degree angle. The nurse will inject the vaccine into the muscle while continuing to tap the skin with the palmar side of the fingers of the non-dominant hand (Stage 3). The nurse will make 3 strokes on the skin with the palmar side of the fingers of the non-dominant hand at the injection site, simultaneously with the 3rd stroke, the needle will be removed from the baby's skin (Stage 4).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural pain score: FLACC Pain Scale
Time Frame: 1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes
The FLACC scale includes the evaluation of five basic behavioural categories. The validity and reliability of the Turkish version of the Pain Diagnostic Scale (FLACC) was conducted. Each of facial expressions, leg movements, activity, crying, and consolability parameters also consists of three sub-items. The items are scored as 0, 1, and 2 point(s) respectively, with total score ranging between 0 to 10 point(s). The "0" point shows that there is no pain, 1-3 points refer to mild pain, 4-6 points refer to moderate pain, and 7-10 points refer to severe pain in infants.
1 min before, during, 1 min after and 3 min after the painful procedure, an average of 4-5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Crying time during the procedure
Time Frame: Through painful procedure completion, an average of 4 minutes
Total crying time during the procedure is the time the newborn cries between 1 min before and 3 min after the painful procedure.
Through painful procedure completion, an average of 4 minutes
Length of procedure time
Time Frame: Through painful procedure completion, an average of 60 seconds
For vaccine administration, it is the time between when the needle is inserted into the skin and when it is removed from the skin.
Through painful procedure completion, an average of 60 seconds

Collaborators and Investigators

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

Sponsor

Istanbul Medeniyet University

Investigators

  • Study Director: Aynur Aytekin Özdemir, PhD, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

July 15, 2024

Primary Completion (Actual)

December 15, 2024

Study Completion (Actual)

December 15, 2024

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20.09.2023/174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Time Frame

September through November of 2025

IPD Sharing Access Criteria

Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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