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

NCT06741670 | Completed

• 1 other identifier: GO 2024/412
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newborn; Pain Management; Breastfeeding; Vibration; Wounds, Penetrating; Needlestick Injuries

Keywords

Newborn; Pain; Breastfeeding; Vibration; Heel Blood Collection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Crying times

  [Time Frame: during the heel blood collection procedures (average 5 minutes)]

• Processing time

  [Time Frame: during the heel blood collection procedures (average 5 minutes)]

• The time to first calming

  [Time Frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)]

Study Arms (4)

Breastfeeding Group

EXPERIMENTAL

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

Behavioral: Breastfeeding

Vibration Group

EXPERIMENTAL

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

Device: Vibration

Breastfeeding+Vibration Group

EXPERIMENTAL

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

Other: Breastfeeding+Vibration

Control Group

NO INTERVENTION

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

Interventions

Breastfeeding BEHAVIORAL

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.

Breastfeeding Group

Vibration 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 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.

Vibration Group

Breastfeeding+Vibration OTHER

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.

Breastfeeding+Vibration Group

Eligibility Criteria

• Age: 2 Days - 4 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Burdur Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Bucak, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Breast Feeding; Wounds, Penetrating; Needlestick Injuries; Pain

Interventions

Lactation

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Wounds and Injuries; Wounds, Stab

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Selda Ateş Beşirik

  Burdur Mehmet Akif Ersoy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single (Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel Assignment Prospective, randomized controlled trial

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: September 2, 2024
• Primary Completion: May 29, 2025
• Study Completion: July 4, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

TU (1)