Vibration and During Heel Lance Procedures in Newborns
The Effect of Vibration on Pain During Heel Lance Procedures in Newborns
interventional
56
1 country
1
Brief Summary
This study aimed to evaluate the effect of applying vibration on pain during heel lance procedures in newborns. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2018
CompletedFirst Submitted
Initial submission to the registry
December 14, 2020
CompletedFirst Posted
Study publicly available on registry
December 19, 2020
CompletedDecember 22, 2020
December 1, 2020
3 months
December 14, 2020
December 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
G Power software was used to calculate the sample size of the study.
G Power
5 days
Study Arms (2)
Vibration Group
EXPERIMENTALIn the vibration group, a vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz) was applied to the middle/side area through which the sural nerve passes immediately below the knee of the extremity from which heel blood was to be collected approximately 30 seconds prior to commencement of the heel lance procedure. The vibration was continued throughout the heel lance procedure unless there was redness, swelling, bruising or a change in the skin integrity in the area to which the vibration was applied, and the vibration was stopped once the procedure was over.
Control Group
NO INTERVENTIONNo interventions were made on the newborns in the control group during the heel lance procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Gestational age 38 and older
You may not qualify if:
- Disrupted skin integrity in the device placement site, nerve damage or -deformity of the limb from which the blood would be collected,
- Genetic and congenital anomalies
- Congenital metabolic disorders,
- those who had undergone cardiopulmonary resuscitation,
- Stayed in the neonatal intensive care unit for any reason,
- Heel blood could not be collected at the first attempt,
- Osteogenesis imperfecta
- Had been given an analgesic within the preceding 6 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziantep University
Gaziantep, 27000, Turkey (Türkiye)
Related Publications (1)
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: 34334677DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 14, 2020
First Posted
December 19, 2020
Study Start
September 9, 2018
Primary Completion
December 12, 2018
Study Completion
December 12, 2018
Last Updated
December 22, 2020
Record last verified: 2020-12