The Effectiveness of Two Different Methods in Heel Blood Collection

December 9, 2024 updated by: Nigde Omer Halisdemir University

Effect of Kinesio Tape and ShotBlocker on Pain, Comfort and Crying Duration in Heel Blood Collection in Infants: Randomized Controlled Trial

This study aims to evaluate the effectiveness of 2 non-pharmacological methods that will reduce the traumatizing effect of routine heel pricking in infant babies within the scope of the metabolic endocrine screening program. One of the interventions to be used in the study is kinesio taping, a type of taping that does not contain any medication. Another intervention is Shotblocker, which does not belong to any drug or device group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies on pain indicate that severe pain experienced in the early period of life causes a weakening of the cognitive functions of the infant, especially by shrinking the thalamic volume. Pain management in the neonatal period aims to help the infant cope with pain by relieving it. For effective pain management, it is very important to diagnose and evaluate the baby's response to pain early and accurately within a multidisciplinary team approach, and to select appropriate interventions to alleviate the pain experience. It is stated that nonpharmacological methods in relieving procedural pain strengthen the baby's natural regulation and coping mechanisms when faced with painful intervention and reduce pain and stress. For this reason, this study aimed to determine the effect of kinesiology taping and ShotBlocker applied to the heel during heel blood collection in infant babies on pain, comfort and crying time.

Study Type

Interventional

Enrollment (Actual)

72

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

  • Turkey
    • Merkez
      • Niğde, Merkez, Turkey
        • Niğde Ömer Halisdemir Eğitim ve Araştırma Hastanesi

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:

  • Term birth infants,
  • Infants with a birth weight of 2500 g and above
  • Infants with stable clinical condition
  • Infants who can perform vital functions without support,
  • Infants who were fed, calm and not crying within one hour before the procedure will be included.

Exclusion Criteria:

  • With a genetic or congenital anomaly,
  • Neurological, cardiological and metabolic diseases,
  • In need of respiratory support,
  • Infants receiving analgesics, antiepileptics before the procedure will be excluded.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kinesio tape group
To the infants in the experimental group; Kinesio tape application will be performed by an experienced physiotherapist whom has a M.Sc. degree and kinesio tape certificate.
Other: Kinesio taping
Kinesio taping will be applied to the lateral part of the baby's heel to increase blood flow. Blood collection will always be performed by the same nurse
Experimental: ShotBlocker group
To the infants in the second experimental group; Shotblocker application will be performed by another researcher.
Other: ShotBlocker
Shotblocker will be applied to the baby's heel average 10-15 seconds with minimal pressure.
No Intervention: Control group
These infants will not receive any intervention in the heel prick procedure. Routine heel blood collection will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the descriptive characteristics of infants
Time Frame: Average 5 minutes
1-Infant Introduction Form The questionnaire created by the researchers consisted of a total of 10 questions including infant gender, gestational age, postnatal age, birth weight and some demographic characteristics.
Average 5 minutes
Follow-up of infants
Time Frame: Average 5 minutes
2- Infant Follow-up Form: This form is the form to record the duration of the procedure and the duration of crying.
Average 5 minutes
The effect of Kinesio tape and ShotBlocker on pain
Time Frame: Average 5 minutes
3- Neonatal Infant Pain Scale (NIPS):This scale, which was developed in 1993 to evaluate behavioral and physiological pain responses of preterm and term infants, was adapted into Turkish in 1999. A high score indicates that the severity of pain.
Average 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .
Time Frame: Average 5 minutes
1-COMFORTneo scale: The scale was revised under the name COMFORTneo scale and its validity and reliability were established. COMFORTneo measures only behavioral parameters in the newborn without physiological parameters. It is Likert-type and evaluates the comfort needs, pain and distress of newborns followed up in intensive care. The lowest score that can be obtained from the scale is 6 and the highest score is 30. As the score increases, it is understood that the baby is not comfortable and needs interventions to provide comfort.
Average 5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Collaborators

Selcuk University

Investigators

  • Principal Investigator: Sibel KUCUKOGLU, Ph.D., Selcuk 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

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)

June 10, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • He1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It will be shared after the article is published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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