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

NCT06380556 | Completed

• 1 other identifier: 25.05.2022/68
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain

Keywords

Procedural pain; Term neonate; Nonpharmacological pain management

Outcome Measures

Primary Outcomes (1)

• Procedural pain score- Neonatal Infant Pain Scale (NIPS)

  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.

  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

Secondary Outcomes (2)

• Crying time

  Through painful procedure completion, an average of 5 minutes

• Procedure time

  Through painful procedure completion, an average of 2 minutes

Study Arms (3)

Control

NO INTERVENTION

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

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

Device: ShotBlocker

Mechanical vibration

EXPERIMENTAL

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

Device: Mechanical vibration

Interventions

ShotBlocker DEVICE

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.

ShotBlocker

Mechanical vibration DEVICE

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.

Mechanical vibration

Eligibility Criteria

• Age: 38 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• with a postnatal age of 24-72 hours,
• birth weight of 2500 g and above,
• th 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 34334677 BACKGROUND

• 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.

  PMID: 27533335 BACKGROUND

• 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.

  PMID: 20697246 BACKGROUND

• 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.

  PMID: 28437308 BACKGROUND

• Catal RA, Ozdemir AA, Karatekin G. Effect of mechanical vibration and ShotBlocker(R) on pain levels during heel lance in healthy term neonates: A randomized controlled trial. J Pediatr Nurs. 2024 Nov-Dec;79:e51-e59. doi: 10.1016/j.pedn.2024.09.019. Epub 2024 Oct 11.

  PMID: 39394025 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using the block randomization technique, participants were divided into three groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B and C using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding). Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind. To avoid statistical bias, study groups were coded as A, B and C; statistical blinding was performed (statistician blinding).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: In the study, participants were assigned to groups by block randomization. Type of delivery (vaginal and cesarean section), gender (male and female) and birth weight (2500-3000 g, 3001-3500 g, 3501 and above) variables were used for block randomization. Blocks were repeated three times in each group and 36 participants were assigned to each. A randomization list with 2 X 2 X 3 X 3 blocks was developed using an online randomization tool. In the study, the group to which the first participant was assigned was determined by a sealed envelope method.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: November 10, 2022
• Primary Completion: January 30, 2023
• Study Completion: July 13, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: September through December of 2025
• 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.

Locations

TU (1)