The Effect of Topical Vibration on Injection Pain in Scalp Block
1 other identifier
interventional
56
1 country
1
Brief Summary
In this study; it's aimed to reduce injection pain during the practice of scalp block, which is used as a method of anesthesia in patients who underwent awake craniotomy surgery. For this purpose, the investigators used topical vibration stimulation, which is non-invasive procedure.
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 Jun 2023
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
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2024
CompletedMay 16, 2024
May 1, 2024
8 months
August 1, 2023
May 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pain score (NRS)
0 ; no pain,10; the worst pain ever possible
during needling (injection) procedure
Secondary Outcomes (2)
Mean arterial pressure (mmHg)
baseline, during needling procedure, 1 min after needling
Heart Rate (beat/min)
baseline, during needling procedure, 1 min after needling
Study Arms (2)
topical vibration
ACTIVE COMPARATORFor all patients one half of the scalp was injected with vibration device.
control
NO INTERVENTIONSame patient's other side of the scalp was injected without vibration device.
Interventions
topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.
Eligibility Criteria
You may qualify if:
- between the ages of 18-75
- ASA (American Society of Anesthesiologists) Scoring I-III
- Cases in which scalp block will be applied
You may not qualify if:
- ASA score IV
- Uncooperative
- Known allergy to any of the study drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
Related Publications (2)
Kuwahara H, Ogawa R. Using a Vibration Device to Ease Pain During Facial Needling and Injection. Eplasty. 2016 Feb 4;16:e9. eCollection 2016.
PMID: 26933468BACKGROUNDYilmaz N, Caparlar CO, Kilincarslan A, Sipahioglu FO, Ozkan D, Unluer C. Effect of topical vibration on pain during scalp block injections in awake craniotomy and deep brain stimulation surgery : Analgesic effects of vibratory stimulation during scalp blocks. Anaesthesiologie. 2025 Nov 7. doi: 10.1007/s00101-025-01604-8. Online ahead of print.
PMID: 41203985DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
nur yilmaz, specialist
Ankara Etlik City Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor medical doctor
Study Record Dates
First Submitted
August 1, 2023
First Posted
September 15, 2023
Study Start
June 1, 2023
Primary Completion
January 30, 2024
Study Completion
February 28, 2024
Last Updated
May 16, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share