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

Istanbul Medeniyet University

Status: Completed

Conditions: Pain, Acute; Procedural Pain; Nursing Caries

Treatments: Device: Mechanical vibration; Behavioral: Helfer skin tap technique (HSTT)

Study type: Interventional

Funder types: Other

Identifiers

NCT06454812

20.09.2023/174

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 6 to 7 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 3 patient groups

Control

No Intervention group

Description:

The control group will receive routine vaccinations.

Mechanical vibration

Experimental group

Description:

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

Treatment:

Device: Mechanical vibration

Helfer skin tap technique

Experimental group

Description:

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

Treatment:

Behavioral: Helfer skin tap technique (HSTT)