The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates
- Conditions
- Procedural Pain
- Interventions
- Device: ShotBlockerDevice: Mechanical vibration
- Registration Number
- NCT06380556
- Lead Sponsor
- Istanbul Medeniyet University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ShotBlocker ShotBlocker ShotBlocker was applied to the infants in this group before and during the heel lance procedure. Mechanical vibration Mechanical vibration Mechanical vibration was applied to the infants in this group before and during the heel lance procedure.
- Primary Outcome Measures
Name Time Method Procedural pain score- Neonatal Infant Pain Scale (NIPS) 1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), 2 min (T+2 min) and 5 min (T+5 min) after the procedure; an average of 6 minutes The scale is used to assess procedural pain in neonates. It is a behavioral scale assessing five behavioral indicators (facial expression, cry, arms, legs, and state of alertness) and one physiological indicator (breathing patterns). Five items (facial expression, breathing pattern, arms, legs, and state of alertness) are scored as 0 (Good) or 1 (Bad), while one item (crying) is scored as 0 (Good), 1, or 2 (Bad). The total scale score ranges from 0 to 7, with higher scores indicating more pain.
- Secondary Outcome Measures
Name Time Method Crying time Through painful procedure completion, an average of 5 minutes Crying time is the crying time between the moment of heel puncture and 5 minutes after the procedure.
Procedure time Through painful procedure completion, an average of 2 minutes The duration of the procedure is the time between the moment of heel lance and the closure of the heel with gauze after the collection of capillary blood.
Trial Locations
- Locations (1)
Istanbul Medeniyet University
🇹🇷Istanbul, Kadıköy, Turkey