Effects of Vibration, Heel Warming and Shotblocker on Pain Levels During Heel Blood Collection

NCT ID: NCT06646848

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2025-05-28

Brief Summary

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.

Detailed Description

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.

Conditions

Newborn; Pain Management; Vibration; Heel Warming; Shotblocker; Wounds, Penetrating; Needlestick Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Vibration Group

Vibration was applied to the infants in this group before and during the heel lance procedure.

Group Type: EXPERIMENTAL

Vibration

Intervention Type: DEVICE

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.

Heel Warming Group

Heel warming was applied to the infants in this group before and during the heel lance procedure.

Group Type: EXPERIMENTAL

Heel Warming

Intervention Type: DEVICE

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.

Shotblocker Group

ShotBlocker was applied to the infants in this group before and during the heel lance procedure.

Group Type: EXPERIMENTAL

Shotblocker

Intervention Type: DEVICE

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.

Control Group

In this group, infants received routine heel blood collection procedure.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vibration

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.

Intervention Type: DEVICE

Heel Warming

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.

Intervention Type: DEVICE

Shotblocker

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Parents who volunteered and gave consent to participate in the research
• Full term neonates (38-42 weeks of gestation)
• Underwent heel stick blood drawing for routine metabolic screening,
• Aged 2 to 4 days
• Passed the hearing screening
• Birth weight between 2500-4400 grams
• Parents who know how to read, write and speak Turkish.

Exclusion Criteria

• Parents with any mental problems
• Infants with any chronic disease and congenital anomalies.

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 4 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burdur Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Selda Ateş Beşirik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selda Ateş Beşirik, PhD.

Role: PRINCIPAL_INVESTIGATOR

Burdur Mehmet Akif Ersoy University

Locations

Burdur Mehmet Akif Ersoy University

Burdur, Bucak, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GO 2024/226

Identifier Type: -

Identifier Source: org_study_id