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Completed

NCT Number: NCT06436391

The Effectiveness of Two Different Methods in Heel Blood Collection

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.

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Key information

Conditions

Infant Behavior Agnosia Behavior Child Behavior Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

38 week–41 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi

Niğde, Merkez, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kinesio Taping

Other

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

shotblocker

Other

Shotblocker will be applied to the baby's heel average 10-15 seconds with minimal pressure.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Nigde Omer Halisdemir University

Other

Collaborators

  • Selcuk University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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