The Effectiveness of Two Different Methods in Heel Blood Collection

NCT06436391 | Completed

• 1 other identifier: He1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Behavior; Pain

Keywords

Pain Management; Kinesiotape; Nursing; Therapy

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

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

  Average 5 minutes

Study Arms (3)

Kinesio tape group

EXPERIMENTAL

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

ShotBlocker group

EXPERIMENTAL

To the infants in the second experimental group; Shotblocker application will be performed by another researcher.

Other: ShotBlocker

Control group

NO INTERVENTION

These infants will not receive any intervention in the heel prick procedure. Routine heel blood collection will be performed.

Interventions

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

Kinesio tape group

ShotBlocker OTHER

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

ShotBlocker group

Eligibility Criteria

• Age: 38 Weeks - 41 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead
• Selcuk University: collaborator

Study Sites (1)

Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi

Niğde, Merkez, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 27964912 BACKGROUND

• 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.

  PMID: 3317037 BACKGROUND

• 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.

  PMID: 28779961 BACKGROUND

• 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.

  PMID: 28160271 BACKGROUND

• 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.

  PMID: 35572360 BACKGROUND

• 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.

  PMID: 27883227 BACKGROUND

MeSH Terms

Conditions

Infant Behavior; Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sibel KUCUKOGLU, Ph.D.

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blinded for mothers
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be conducted with infants of mothers who meet the inclusion criteria and agree to participate in the study. After explaining the study to the parents, the study will start after obtaining their verbal and written consent. Randomization will be random assignment to a control group or two intervention groups (1:1:1) with sequentially numbered, sealed, opaque envelopes containing randomly generated numbers after mothers have obtained informed consent. Randomization will be carried out via www.random.org using a table of random numbers. This will be done by an independent statistician and envelopes will be given to the researchers

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 31, 2024
• Study Start: June 10, 2024
• Primary Completion: August 31, 2024
• Study Completion: September 20, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)