The Effect of Warming and Vibration Applications on Pain in Newborns
NCT ID: NCT06607575
Last Updated: 2025-05-06
Study Results
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Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2024-10-15
2025-03-12
Brief Summary
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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.
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Detailed Description
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Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group
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.
Control group
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.
Experimental group (warming)
Newborns who will be subjected to warming application during the heel blood collection procedure will constitute the 1st experimental group.
Warming
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 (vibration)
Newborns who will be subjected to vibration during the heel blood collection procedure will constitute the 2nd experimental group.
Vibration
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 (warming and vibration)
Newborns who will be subjected to both warming and vibration during the heel blood collection procedure will constitute the 3rd experimental group.
Warming and vibration
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.
Interventions
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Control group
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.
Warming
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.
Vibration
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.
Warming and vibration
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.
Eligibility Criteria
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Inclusion Criteria
* Healthy newborns
Exclusion Criteria
* Newborns with congenital diseases
1 Day
28 Days
ALL
Yes
Sponsors
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Acibadem University
OTHER
Responsible Party
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Zehra Kan Onturk
Assoc. Prof.
Principal Investigators
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Hande Keskin Nurse
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
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Acıbadem University
Istanbul, Ata, Turkey (Türkiye)
Acıbadem University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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ATADEK 2023-10/403
Identifier Type: -
Identifier Source: org_study_id
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