Effects of Three Different Methods in Reducing Pain During Heel Blood Collection

Determination of the Effects of Three Different Methods in Reducing Pain During Heel Blood Collection; Breastfeeding, Vibration, and Breastfeeding+Vibration: A Randomized Controlled Study

This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration on pain levels during heel blood collection on healthy term newborn's.

Study Overview

• Status: Completed
• Conditions: Pain Management; Newborn; Breastfeeding; Needlestick Injuries; Wounds, Penetrating; Vibration
• Intervention / Treatment: Behavioral: Breastfeeding; Device: Vibration; Other: Breastfeeding+Vibration

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 Breastfeeding, Vibration, and Breastfeeding+Vibration 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; Breastfeeding group (n=48), Vibration group (n=48), Breastfeeding+Vibration 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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bucak
    • Burdur, Bucak, Turkey, 15030
      • Burdur Mehmet Akif Ersoy University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; In this group, infants received routine heel blood collection procedure.
Experimental: Vibration Group; Vibration was applied to the infants in this group before and during the heel lance procedure.	Device: 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 infants in the Vibration Group will be placed in their mother's arms and vibration will be applied 30 seconds before the routine application, and vibration will be applied during the 10-second waiting phase while the nurse performs the heel prick blood collection procedure.
Experimental: Breastfeeding Group; Breastfeeding was applied to the infants in this group before and during the heel lance procedure.	Behavioral: Breastfeeding; The routine practice of the Breastfeeding Group is to place the infants in their mother's arms and start breastfeeding 1 minute before the procedure. Then, the nurse will take the heel blood.
Experimental: Breastfeeding+Vibration Group; Breastfeeding+Vibration was applied to the infants in this group before and during the heel lance procedure.	Other: Breastfeeding+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 routine practice for the Breastfeeding+Vibration Group babies will be started by holding them in their mother's arms and breastfeeding will be started 1 minute before the application. At the same time, vibration will be applied 30 seconds before the application and vibration will be applied in a 10-second waiting phase while the nurse performs the heel prick procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	average 5 minutes) during the heel blood collection procedures (1 minute before the heel lance procedure (T-1 minute), during the procedure (T+0 second), and 2 minutes (T+2 minutes)]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]

Collaborators and Investigators

• Sponsor: Burdur Mehmet Akif Ersoy University
• Investigators: Principal Investigator: Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): May 29, 2025
• Study Completion (Actual): July 4, 2025

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: December 15, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Pain; Vibration; Newborn; Breastfeeding; Heel Blood Collection
• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Stab; Wounds, Penetrating; Needlestick Injuries
• Other Study ID Numbers: GO 2024/412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No