Clinical trial NCT06436391: The Effectiveness of Two Different Methods in Heel Blood Collection
Official title: Effect of Kinesio Tape and ShotBlocker on Pain, Comfort and Crying Duration in Heel Blood Collection in Infants: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Behavior
Pain
Keywords: Pain Management
Kinesiotape
Nursing
Therapy
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
Collaborators: name: Selcuk University
First posted: 2024-05-31
Enrollment: 72
Sex: ALL
Minimum age (years): 38
Maximum age (years): 41
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determining the descriptive characteristics of infants
timeFrame: Average 5 minutes
measure: Follow-up of infants
timeFrame: Average 5 minutes
measure: The effect of Kinesio tape and ShotBlocker on pain
timeFrame: Average 5 minutes
Secondary outcomes:
measure: The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .
timeFrame: Average 5 minutes
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi
state: Merkez
Study officials:
affiliation: Selcuk University
name: Sibel KUCUKOGLU, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.