The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates

Istanbul Medeniyet University

Status: Completed

Conditions: Procedural Pain

Treatments: Device: ShotBlocker; Device: Mechanical vibration

Study type: Interventional

Funder types: Other

Identifiers

NCT06380556

25.05.2022/68

Details and patient eligibility

About

This study was conducted to determine the effect of mechanical vibration and ShotBlocker methods on pain level, crying time and procedure time during heel prick blood collection in healthy term infants.

Full description

Heel prick blood collection, which is one of the painful medical procedures, is one of the diagnostic methods used in newborns and is a more painful procedure compared to other blood collection procedures. Prevention of pain in newborns should be the primary goal of all healthcare personnel working with newborns, both because it is an ethical obligation and because repeated painful exposures have the potential to cause harmful consequences. Nonpharmacologic methods used for the control of acute pain associated with medical procedures are easy to use, have no side effects, are inexpensive and time-saving. Mechanical vibration and ShotBlocker application are among the non-pharmacologic methods frequently used in the management of pain associated with heel prick procedure in term infants.

Previous studies have shown that parent-related methods (kangaroo care, mother/father hug, breastfeeding, etc.) are commonly used for pain management of the newborn during heel prick. In this respect, it is important to determine the effectiveness of mechanical vibration and ShotBlocker methods that can be used independently of the parent, especially in intensive care settings where access to the parent is not always possible.

Enrollment: 108 patients

Sex: All

Ages: 38 to 42 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• with a postnatal age of 24-72 hours,
• birth weight of 2500 g and above,
• 5th minute APGAR score above 6,
• able to carry out vital activities without support,
• fed within one hour before the procedure,
• calm and not crying before the procedure,
• babies who had heel prick for the first time

Exclusion criteria

• with genetic or congenital anomaly,
• with neurological, cardiological and metabolic diseases,
• in need of respiratory support,
• having a history of sedative, analgesic, or narcotic use within 24 h before admission,
• hospitalization and surgical procedure experience in neonatal intensive care unit,
• experience with needle interventions other than vitamin K and Hepatitis B vaccine,
• babies of mothers with a history of substance abuse

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 heel lance procedure of the infants in the control group was performed according to the routine heel lance procedure of the clinic.

ShotBlocker

Experimental group

Description:

ShotBlocker was applied to the infants in this group before and during the heel lance procedure.

Treatment:

Device: ShotBlocker

Mechanical vibration

Experimental group

Description:

Mechanical vibration was applied to the infants in this group before and during the heel lance procedure.

Treatment:

Device: Mechanical vibration