Pain Assessment of a new bloodletting device: A study protocol for a randomized, controlled, double-blind, matched-paired clinical trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004478

Enrollment

100

Registered

2019-11-27

Start date

2019-10-21

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Test device : Disposable manual lancet(ROAH-L-NO1) Control device : lancet(GMMC? LANZO 1.5) According to the randomization code, a total of 2 procedures are performed, one for each ha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) 19-64 year old male and female (2) Able to collect blood on the same finger of both hands (3) Subject who agrees to participate in the study and signs the informed consent form (4) Those who can communicate smoothly and express pain

Exclusion criteria

Exclusion criteria: (1) Those with blood clotting disorders, such as hemophilia or leukemia (2) Those who have structural disorders such as defects or deformations in the blood collection area (3) Those who should avoid blood stimulation due to wounds, skin diseases, etc. (4) Those with sensory disorders in the area of blood collection, such as hemiplegia or peripheral nerve damage (5) Any other researcher deemed inappropriate for this test

Design outcomes

Primary

Measure	Time frame
VAS(Visual Analog Scale)	—

Secondary

Measure	Time frame
VRS(Verbal Rating Scale)	—

Countries

Korea, Republic of

Contacts

Public ContactHwa-yeon Ryu

Cheonan Korean Medicine Hospital of Daejeon University

nanhy1302@gmail.com+82-41-521-7578

Outcome results