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The Effectiveness of Two Different Methods in Heel Blood Collection

NCT ID: NCT06436391

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2024-09-20

Brief Summary

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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

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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.

Conditions

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Infant Behavior Pain

Keywords

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Pain Management Kinesiotape Nursing Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single Blinded for mothers

Study Groups

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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.

Group Type EXPERIMENTAL

Kinesio taping

Intervention Type 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 group

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

Group Type EXPERIMENTAL

ShotBlocker

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

ShotBlocker

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

38 Weeks

Maximum Eligible Age

41 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role collaborator

Nigde Omer Halisdemir University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sibel KUCUKOGLU, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Selcuk University

Locations

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Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi

Niğde, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27964912 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3317037 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28779961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28160271 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35572360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27883227 (View on PubMed)

Other Identifiers

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He1

Identifier Type: -

Identifier Source: org_study_id