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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-07-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Procedural Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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).

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

ShotBlocker

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

Group Type EXPERIMENTAL

ShotBlocker

Intervention Type 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.

Mechanical vibration

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

Group Type EXPERIMENTAL

Mechanical vibration

Intervention Type 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.

Interventions

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ShotBlocker

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.

Intervention Type DEVICE

Mechanical vibration

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

38 Weeks

Maximum Eligible Age

42 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes