The Effect of Warming and Vibration Applications on Pain in Newborns

NCT06607575 | Completed

• 1 other identifier: ATADEK 2023-10/403
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

This study aimed to determine the effects of warming and vibration applications on pain during heel blood collection in newborns. H1: Warming application has a positive effect on pain during heel blood collection in newborns. H2: Vibration application has a positive effect on pain during heel blood collection in newborns. H3: The combined application of warming and vibration during heel blood collection in newborns has a positive effect on pain.

Conditions

Pain

Keywords

Newborn; pain; vibration; warming; heel blood collection; infant

Outcome Measures

Primary Outcomes (1)

• Change in level of pain

  The level of pain will be measured using the N-PASS: Neonatal Pain/Agitation, Sedation Scale. The scale was developed by Hummel, Lawlor-Klean and Weiss in 2010, its Turkish validity and reliability were made by Açıkgöz et al. in 2017. N-PASS consists of two sections: sedation and pain assessment. Total pain score varies between 0 and +11 and total sedation score varies between 0 and +10. A high score indicates severe pain. The aim is to keep the score at 3 and below. If it is above 3 points, sedation requirements are evaluated. The average time spent to administer the scale is 1 minute.

  Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.

Study Arms (4)

Control group

OTHER

Newborns who will be subjected to routine practices during heel blood collection procedure and who will not be subjected to warming and vibration will constitute the control group.

Other: Control group

Experimental group (warming)

EXPERIMENTAL

Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group.

Other: Warming

Experimental group (vibration)

EXPERIMENTAL

Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group.

Other: Vibration

Experimental group (warming and vibration)

EXPERIMENTAL

Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group.

Other: Warming and vibration

Interventions

Control group OTHER

1. The procedure for heel blood collection will be performed. 2. Pain assessment will be performed with the N-PASS scale during and after the procedure.

Control group

Warming OTHER

1. The cotton sock will be warmed under the heater for 3 minutes. The sock will be put on the newborn and taken off after 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.

Experimental group (warming)

Vibration OTHER

1. A rechargeable toothbrush will be prepared for the newborn to whom vibration will be applied. The vibration process will be applied to the midline of the gastrocnemius muscle for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.

Experimental group (vibration)

Warming and vibration OTHER

1. After the socks are warmed, they will be put on the newborn\'s feet and both warming and vibration will be applied for 3 minutes. 2. The procedure for heel blood collection will be performed. 3. Pain assessment will be performed with the N-PASS scale during and after the procedure.

Experimental group (warming and vibration)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns at 38 weeks of gestation and above
• Healthy newborns

You may not qualify if:

• Newborns with any lower extremity anomalies
• Newborns with congenital diseases

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (2)

Acıbadem University

Istanbul, Ata, Turkey (Türkiye)

Location

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

Related Publications (5)

• Avan Antepli N, Bilsin Kocamaz E, Gungormus Z. The Effect of Vibration on Pain During Heel Lance Procedures in Newborns: A Randomized Controlled Trial. Adv Neonatal Care. 2022 Apr 1;22(2):E43-E47. doi: 10.1097/ANC.0000000000000918.

  PMID: 34334677 BACKGROUND

• Shepherd AJ, Glenesk A, Niven CA, Mackenzie J. A Scottish study of heel-prick blood sampling in newborn babies. Midwifery. 2006 Jun;22(2):158-68. doi: 10.1016/j.midw.2005.07.002. Epub 2005 Dec 28.

  PMID: 16386341 BACKGROUND

• Ray R, Godwin Y, Shepherd A. Convective burn from use of hairdryer for heel warming prior to the heel prick test - a case report. BMC Pediatr. 2011 May 10;11:30. doi: 10.1186/1471-2431-11-30.

  PMID: 21569274 BACKGROUND

• Napiorkowska-Orkisz M, Gutysz-Wojnicka A, Tanajewska M, Sadowska-Krawczenko I. Evaluation of Methods to Minimize Pain in Newborns during Capillary Blood Sampling for Screening: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Jan 13;19(2):870. doi: 10.3390/ijerph19020870.

  PMID: 35055694 BACKGROUND

• Hassan Z, Shah M. Scald injury from the Guthrie test: should the heel be warmed? Arch Dis Child Fetal Neonatal Ed. 2005 Nov;90(6):F533-4. doi: 10.1136/adc.2005.072678.

  PMID: 16244215 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Control Groups; Vibration

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Mechanical Phenomena; Physical Phenomena

Study Officials

• Hande Keskin Nurse

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: October 15, 2024
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)