The Effectiveness of Two Different Methods in Heel Blood Collection

Not Applicable

Completed

• Conditions: Infant Behavior; Pain
• Interventions: Other: Kinesio taping; Other: ShotBlocker

• Registration Number: NCT06436391
• Lead Sponsor: Nigde Omer Halisdemir University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-05-31
• Study Start: 2024-06-10
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kinesio tape group	Kinesio taping	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.
ShotBlocker group	ShotBlocker	To the infants in the second experimental group; Shotblocker application will be performed by another researcher.

Primary Outcome Measures

Name	Time	Method
Determining the descriptive characteristics of infants	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.
Follow-up of infants	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.
The effect of Kinesio tape and ShotBlocker on pain	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 Outcome Measures

Name	Time	Method
The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .	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.

Trial Locations

Locations (1)

Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi; 🇹🇷 Niğde, Merkez, Turkey