The Effectiveness of Two Different Methods in Heel Blood Collection

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436391
• Other study ID #: He1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Nigde Omer Halisdemir University
• Contact: Hilal KURT SEZER, Ph.D.
• Phone: +903882112815
• Email: hilalkurt26[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Weeks to 41 Months

Eligibility

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.

Related Conditions & MeSH terms

• Infant Behavior
• Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nigde Omer Halisdemir University	Selcuk University

References & Publications (6)

Anand KJ, Hickey PR. Pain and its effects in the human neonate and fetus. N Engl J Med. 1987 Nov 19;317(21):1321-9. doi: 10.1056/NEJM198711193172105. No abstract available. — View Citation

Chik YM, Ip WY, Choi KC. The Effect of Upper Limb Massage on Infants' Venipuncture Pain. Pain Manag Nurs. 2017 Feb;18(1):50-57. doi: 10.1016/j.pmn.2016.10.001. Epub 2016 Dec 10. — View Citation

Erkut Z, Yildiz S. The Effect of Swaddling on Pain, Vital Signs, and Crying Duration during Heel Lance in Newborns. Pain Manag Nurs. 2017 Oct;18(5):328-336. doi: 10.1016/j.pmn.2017.05.007. Epub 2017 Aug 2. — View Citation

Foster JP, Taylor C, Spence K. Topical anaesthesia for needle-related pain in newborn infants. Cochrane Database Syst Rev. 2017 Feb 4;2(2):CD010331. doi: 10.1002/14651858.CD010331.pub2. — View Citation

Harvey EG. Kinesio taping to address post-sternotomy scars in pediatric patients: A case report. Scars Burn Heal. 2022 May 11;8:20595131221095355. doi: 10.1177/20595131221095355. eCollection 2022 Jan-Dec. — View Citation

Kurdahi Badr L, Demerjian T, Daaboul T, Abbas H, Hasan Zeineddine M, Charafeddine L. Preterm infants exhibited less pain during a heel stick when they were played the same music their mothers listened to during pregnancy. Acta Paediatr. 2017 Mar;106(3):438-445. doi: 10.1111/apa.13666. Epub 2016 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining the descriptive characteristics of infants	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
Primary	Follow-up of infants	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
Primary	The effect of Kinesio tape and ShotBlocker on pain	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	The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .	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