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

NCT06454812 | Completed

• 1 other identifier: 20.09.2023/174
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Pain; Nursing Caries; Pain, Acute

Keywords

Healthy infant; Nonpharmacological pain management; Procedural pain

Outcome Measures

Primary Outcomes (1)

• Procedural pain score: FLACC Pain Scale

  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 Outcomes (2)

• Crying time during the procedure

  Through painful procedure completion, an average of 4 minutes

• Length of procedure time

  Through painful procedure completion, an average of 60 seconds

Study Arms (3)

Control

NO INTERVENTION

The control group will receive routine vaccinations.

Mechanical vibration

EXPERIMENTAL

Mechanical vibration will be used during routine vaccination of infants in this group.

Device: Mechanical vibration

Helfer skin tap technique

EXPERIMENTAL

Helfer skin tap technique will be used during routine vaccinations of infants in this group.

Behavioral: Helfer skin tap technique (HSTT)

Interventions

Mechanical vibration DEVICE

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.

Mechanical vibration

Helfer skin tap technique (HSTT) BEHAVIORAL

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).

Helfer skin tap technique

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (4)

• Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.

  PMID: 34334677 BACKGROUND

• McGinnis K, Murray E, Cherven B, McCracken C, Travers C. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial. Adv Neonatal Care. 2016 Dec;16(6):439-448. doi: 10.1097/ANC.0000000000000315.

  PMID: 27533335 BACKGROUND

• Baba LR, McGrath JM, Liu J. The efficacy of mechanical vibration analgesia for relief of heel stick pain in neonates: a novel approach. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):274-83. doi: 10.1097/JPN.0b013e3181ea7350.

  PMID: 20697246 BACKGROUND

• Guven SD, Cakirer Calbayram N. The effect of Helfer skin tap technique on hepatitis B vaccine intramuscular injection pain in neonates: A randomized controlled trial. Explore (NY). 2023 Mar-Apr;19(2):238-242. doi: 10.1016/j.explore.2022.09.001. Epub 2022 Sep 8.

  PMID: 36115789 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using the block randomization technique, participants will be divided into 3 groups. A web-based randomization list creation tool will be used to create the blocked randomization list. Control and intervention groups will be coded as A, B and C using the sealed envelope method. Randomization information will be kept from the researcher involved in data collection until data collection begins. The researcher will learn which group each baby is in just before the application (researcher blinding). Parents will know which group the baby is in within the scope of the research. By the nature of the sample group, babies are blind. Research data will be entered into the computer database by coding the group name as A, B and C, and statistical analysis will be performed using this coding (statistician blinding).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be assigned to experimental and control groups using block randomization method. Body weight and sex variables will be used for block randomization.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: July 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: January 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: September through November of 2025
• 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.

Locations

TU (1)