The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates
April 18, 2024 updated by: Aynur Aytekin Ozdemir, Istanbul Medeniyet University
The Effect of Mechanical Vibration and ShotBlocker on Pain Levels During Heel Lance in Healthy Term Neonates: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kadıköy
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Istanbul, Kadıköy, Turkey, 34720
- Istanbul Medeniyet University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
The heel lance procedure of the infants in the control group was performed according to the routine heel lance procedure of the clinic.
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Experimental: ShotBlocker
ShotBlocker was applied to the infants in this group before and during the heel lance procedure.
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The protruding surface of the ShotBlocker was placed on the heel lance procedure site.
While applying pressure on the skin through the ShotBlocker, the nurse performed heel lancing with the needle through the opening in the center of the ShotBlocker.
During the 10-second waiting phase, the ShotBlocker was kept at the procedure site with the same pressure.
Then ShotBlocker was removed from the skin and routine capillary blood collection procedure was performed.
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Experimental: Mechanical vibration
Mechanical vibration was applied to the infants in this group before and during the heel lance procedure.
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The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes.
The device was secured to the extremity with a gauze bandage.
The vibration device was operated for 30 seconds with reference to previous studies.
While the vibration continued, the nurse punctured the heel with a needle.
Then, the vibration device continued to work in the waiting phase for 10 seconds.
The vibration device was removed from the baby's extremity and routine capillary blood collection procedure was performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedural pain score- Neonatal Infant Pain Scale (NIPS)
Time Frame: 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.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Crying time
Time Frame: Through painful procedure completion, an average of 5 minutes
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Crying time is the crying time between the moment of heel puncture and 5 minutes after the procedure.
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Through painful procedure completion, an average of 5 minutes
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Procedure time
Time Frame: Through painful procedure completion, an average of 2 minutes
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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.
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Through painful procedure completion, an average of 2 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aynur Aytekin Özdemir, PhD, Istanbul Medeniyet University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Caglar S, Buyukyilmaz F, Cosansu G, Caglayan S. Effectiveness of ShotBlocker for Immunization Pain in Full-Term Neonates: A Randomized Controlled Trial. J Perinat Neonatal Nurs. 2017 Apr/Jun;31(2):166-171. doi: 10.1097/JPN.0000000000000256.
- Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.
- McGinnis K, Murray E, Cherven B, McCracken C, Travers C. Effect of Vibration on Pain Response to Heel Lance: A Pilot Randomized Control Trial. Adv Neonatal Care. 2016 Dec;16(6):439-448. doi: 10.1097/ANC.0000000000000315.
- Baba LR, McGrath JM, Liu J. The efficacy of mechanical vibration analgesia for relief of heel stick pain in neonates: a novel approach. J Perinat Neonatal Nurs. 2010 Jul-Sep;24(3):274-83. doi: 10.1097/JPN.0b013e3181ea7350.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 10, 2022
Primary Completion (Actual)
January 30, 2023
Study Completion (Actual)
July 13, 2023
Study Registration Dates
First Submitted
April 18, 2024
First Submitted That Met QC Criteria
April 18, 2024
First Posted (Actual)
April 24, 2024
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.05.2022/68
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
IPD Sharing Time Frame
September through December of 2025
IPD Sharing Access Criteria
Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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