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

Not Applicable

Completed

• Conditions: Procedural Pain; Pain, Acute; Nursing Caries
• Interventions: Device: Mechanical vibration; Behavioral: Helfer skin tap technique (HSTT)

• Registration Number: NCT06454812
• Lead Sponsor: Istanbul Medeniyet University

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.

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 Timeline

• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Study Start: 2024-07-15
• Status Verified: 2024-11
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical vibration	Mechanical vibration	Mechanical vibration will be used during routine Hepatitis B vaccination of infants in this group.
Helfer skin tap technique	Helfer skin tap technique (HSTT)	Helfer skin tap technique will be used during routine Hepatitis B vaccination of infants in this group.

Primary Outcome Measures

Name	Time	Method
Procedural pain score: FLACC Pain Scale	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.

Secondary Outcome Measures

Name	Time	Method
Crying time during the procedure	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.
Length of procedure time	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.

Trial Locations

Locations (1)

Istanbul Medeniyet University; 🇹🇷 Istanbul, Kadıköy, Turkey