Clinical trial NCT06607575: The Effect of Warming and Vibration Applications on Pain in Newborns
Official title: The Effect of Warming and Vibration Applications on Pain During Heel Blood Collection in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Newborn
pain
vibration
warming
heel blood collection
infant
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Heel blood collection is frequently used for neonatal metabolic screening and analysis of bilirubin, glucose and other biochemical/hematologic parameters. This process is both painful and stressful for the newborn. Pain experience in the neonatal period can cause intense stress in the infant and cause physiopathological changes such as respiratory irregularity, impaired thermoregulation, changes in heart rhythm, changes in oxygen saturation and blood pressure. Therefore, it is recommended to use evidence-based non-pharmacological methods to reduce the pain experiences of newborns and to minimize the short and long-term negative effects of pain.

Based on this rationale, this study was planned to evaluate the effect of non-pharmacologic methods on pain and procedure time together.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in level of pain
timeFrame: Immediately before the prosedure, during the procedure, immediately after the procedure. The change in these time period will be measured.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem University
state: Ata
city: İstanbul
country: Turkey
facility: Acıbadem University
state: Ataşehir
Study officials:
affiliation: Acibadem University
name: Hande Keskin Nurse
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.