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

I

Istanbul Medeniyet University

Status

Completed

Conditions

Procedural Pain

Treatments

Device: Mechanical vibration
Device: ShotBlocker

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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