An interventional study of Vibration and Heel Warming in Newborn, Pain Management and Vibration, sponsored by Burdur Mehmet Akif Ersoy University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 2 Days to 4 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Burdur Mehmet Akif Ersoy University · Not applicable, Interventional, and Supportive care
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Vibration, Heel Warming, and Shotblocker on pain levels during heel blood collection on healthy term newborn's.
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.
This study is a prospective, randomized and controlled trial. In this study aim, the effect of Vibration, Heel Warming, and Shotblocker during heel blood collection on the pain levels in healthy term newborn's will be examined.
Sample of the study consisted of a total of 192 newborns who met the sample selection criteria and were selected via randomization method.
Newborns were divided into four groups; Vibration group (n=48), Heel Warming group (n=48), Shotblocker group (n=48), and Control group (n=48).
Data were collected using the Infant-family Information Form and NIPS - Neonatal Infant Pain Scale.
Data collection All blood sampling was performed in a quiet nursery room between 09:00 AM and 11:00 AM, 1-2 hours after breastfeeding, the normal time when infants undergo heel stick for routine blood collection for metabolic screening. Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years' experience in the performance heel stick and had no conflict of interest. A pediatrician made the clinical decision for heel stick.
Before the procedure, the newborns were kept in a quiet room far away from the cries of other babies. The infants' diapers were changed before procedure. For the heel stick procedure, the antiseptic solution (70% alcohol), heel stick method, heel region for sampling (the outer right side of the ball), needle (21-G needle), and environmental factors such as heat, light, and noise were all standardized. The whole procedure was video-recorded until three minutes after the procedure.
At the beginning of the study, the parents of the newborns were informed about the aim and content of the research, and parental approval was obtained. Neonatal and family demographics were collected using self-report information forms, which included medical history, mother's gestational age, neonatal age, sex, birth weight, duration of sampling, total crying time, processing time, and the time from the start of the first cry to the first crying during the process.
All blood sampling in the study was performed for clinical purposes, such as newborn metabolic screening tests, which were taken on the second to third days following birth. The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant, lancing the heel, and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected.
All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure. After the procedure the newborns' pain levels and crying duration were evaluated using the video recordings. Assessment of pain was conducted independently by the investigator and the nurse using NIPS. At the same time, the newborns' total procedural crying time, the duration of the procedure, and the first calming time were recorded. The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying. The time of the procedure was measured from the beginning to the end of the heel stick procedure. The calming time was measured from the time of the first cry to the first calming time.
Exclusion Criteria:
Vibration was applied to the infants in this group before and during the heel lance procedure.
Device: Vibration
Heel warming was applied to the infants in this group before and during the heel lance procedure.
Device: Heel Warming
ShotBlocker was applied to the infants in this group before and during the heel lance procedure.
Device: Shotblocker
In this group, infants received routine heel blood collection procedure.
The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The vibration device was operated for 30 seconds with reference to previous studies. While the vibration continued, the nurse punctured the heel with a needle. Then, the vibration device continued to work in the waiting phase for 10 seconds. The vibration device was removed from the infants's extremity and routine heel blood collection procedure was performed.
The heel warning group will warm the heel of the infants using a hot thermal bag 3-5 minutes before the application. Then, the thermal bag will be removed and the nurse will take the heel blood.
The protruding surface of the Shotblocker was placed on the heel lance procedure site. While applying pressure on the skin through the Shotblocker, the nurse performed heel lancing with the needle through the opening in the center of the Shotblocker. During the 10-second waiting phase, the Shotblocker was kept at the procedure site with the same pressure. Then Shotblocker was removed from the skin and routine capillary heel collection procedure was performed.
NIPS (Neonatal Infant Pain Scale)
It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.
Time frame: (average 5 minutes) during the heel blood collection procedures (1 min before the heel lance procedure (T-1 min), during the procedure (T+0 sec), and 2 min (T+2 min)
Crying times
Duration of crying were recorded.
Time frame: during the heel blood collection procedures (average 5 minutes)
Processing time
Duration of heel blood collection procedure were recorded.
Time frame: during the heel blood collection procedures (average 5 minutes)
The time to first calming
The calming time was measured from the time of the first cry to the first calming time.
Time frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)
Plan to share: Yes — Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Burdur Mehmet Akif Ersoy University