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Infant BehaviorNCT06436391

The Effectiveness of Two Different Methods in Heel Blood Collection

A study testing Kinesio taping and ShotBlocker in people with Infant Behavior and Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 38 weeks to 41 monthsHealthy volunteers can take part
Conditions the study is for
Infant Behavior, Pain
What is being tested?
Kinesio taping and ShotBlocker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Jun 2024to 20 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 38 weeks to 41 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Nigde Omer Halisdemir Eğitim ve Araştırma Hastanesi

    Niğde, Merkez

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Kinesio taping, ShotBlocker
Keywords
Pain Management, Kinesiotape, Nursing, Therapy
Medical subject headings
Infant Behavior, Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinesio tapingOther

    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

  • ShotBlockerOther

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

Study groups in NCT06436391
Study groupRoleWhat they receive
Kinesio tape groupExperimentalTo 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.
Receives: Other: Kinesio taping
ShotBlocker groupExperimentalTo the infants in the second experimental group; Shotblocker application will be performed by another researcher.
Receives: Other: ShotBlocker
Control groupNo interventionThese infants will not receive any intervention in the heel prick procedure. Routine heel blood collection will be performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Average 5 minutes

  2. 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.

    Measured: Average 5 minutes

  3. 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.

    Measured: Average 5 minutes

Secondary outcomes (1)

  1. 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.

    Measured: Average 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study start10 Jun 2024
  3. Primary completion31 Aug 2024
  4. Study completion20 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Single blind
Who is masked
Participant
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06436391
Sponsor's protocol ID
He1
Status last verified
Dec 2024
First submitted
8 May 2024
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It will be shared after the article is published

Publications

  • 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.

    PubMed 27964912

  • 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.

    PubMed 3317037

  • 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.

    PubMed 28779961

  • 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.

    PubMed 28160271

  • 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.

    PubMed 35572360

  • 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.

    PubMed 27883227

Questions about this trial

What is this clinical trial studying?

A study testing Kinesio taping and ShotBlocker in people with Infant Behavior and Pain, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determining the descriptive characteristics of infants (time frame: Average 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06436391, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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