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The Effectiveness of Two Different Methods in Heel Blood Collection

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06436391
Enrollment
72
Registered
2024-05-31
Start date
2024-06-10
Completion date
2024-09-20
Last updated
2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Behavior, Pain

Keywords

Pain Management, Kinesiotape, Nursing, Therapy

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.

Interventions

OTHERKinesio 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

OTHERShotBlocker

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

Sponsors

Selcuk University
CollaboratorOTHER
Nigde Omer Halisdemir University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Single Blinded for mothers

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

Eligibility

Sex/Gender
ALL
Age
38 Weeks to 41 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Determining the descriptive characteristics of infantsAverage 5 minutes1-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.
Follow-up of infantsAverage 5 minutes2- Infant Follow-up Form: This form is the form to record the duration of the procedure and the duration of crying.
The effect of Kinesio tape and ShotBlocker on painAverage 5 minutes3- 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.

Secondary

MeasureTime frameDescription
The effect of Kinesio tape and ShotBlocker application in infants in the experimental groups' comfort .Average 5 minutes1-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026