Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT05668702
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2022-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Glucose Measurement in Terms Ofg Pain and Result Consistency
Sponsor:
Melek Sahin
Organization:
Study Overview
Official Title:
A Comparison of Two Regions Used in Capillary Blood Glucose Test in Terms of Pain and Result Consistency
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Abstract Background: Capillary blood glucose measurement is one of the invasive procedures frequently used in clinics, hospitals and home.
Aim: To determine the consistency of pain and results between the palm and fingertip in obtaining blood sample with the intention of monitoring capillary blood glucose.
Design: This study is a crossover design designated. Settings: The research was carried out Diabetes Polyclinic Participants: One hundred thirty Type 2 diabetes patients who went to Diabetes Polyclinic Methods: The research was carried out with 130 Type 2 diabetes patients who went to Diabetes Polyclinic between August and November, 2018. During the data collection, the researcher took venous blood sample in a tube from each patient and according to the list of order determined via randomization scheme formed on the computer, the patients' glucose levels were measured by taking a capillary blood sample from the side of the middle fingertip and palm of the dominant hand with the glucometer. Before the study, the patient's pain assessment at the end of each measurement was carried out by a nurse who was trained by the researcher about the use of Visual Analog Scale.
Keywords: capillary blood sampling; fingertip; glucose; pain; palm
Aim: To determine the consistency of pain and results between the palm and fingertip in obtaining blood sample with the intention of monitoring capillary blood glucose.
Design: This study is a crossover design designated. Settings: The research was carried out Diabetes Polyclinic Participants: One hundred thirty Type 2 diabetes patients who went to Diabetes Polyclinic Methods: The research was carried out with 130 Type 2 diabetes patients who went to Diabetes Polyclinic between August and November, 2018. During the data collection, the researcher took venous blood sample in a tube from each patient and according to the list of order determined via randomization scheme formed on the computer, the patients' glucose levels were measured by taking a capillary blood sample from the side of the middle fingertip and palm of the dominant hand with the glucometer. Before the study, the patient's pain assessment at the end of each measurement was carried out by a nurse who was trained by the researcher about the use of Visual Analog Scale.
Keywords: capillary blood sampling; fingertip; glucose; pain; palm
Detailed Description:
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
The data were collected by the researcher in the diabetes outpatient clinic where there is a sink for handwashing and a suitable area and equipment for blood collection. The researcher interviewed the patients who applied to the diabetes outpatient clinic, informed them about the study and obtained their written consents. After obtaining their written consents, the information of the patients was recorded in the Patient Identification Form. Then, the patients were informed about the use of the Visual Analog Scale. First, venous blood samples of the patients were collected into a tube by the researcher, and then their capillary blood samples were taken. A randomization scheme was created via the website https://www.randomizer.org/ in order to prevent bias during the evaluation of the pain felt due to drawing of capillary blood. According to this randomization order, patients were randomly assigned to one of the two groups. For capillary blood glucose measurement, two regions, fingertip and palm were used in every patient. In the first group, capillary blood glucose samples were taken first from the fingertip and then from the palm, and in the second group the capillary blood sample was first obtained from the palm and then the fingertip, and blood glucose measurements were made with the glucometer. The patient washed his/her hands with warm water and soap and dried them with a paper towel. Prior to capillary blood collection, the patient washed his/her hands with warm water, kept his hand below the level of the heart, waved downwards and gently massaged his/her fingertips in order to obtain appropriate amount of blood. The dominant hands of the patients were used to collect capillary blood samples. In order not to affect the research results, the same glucometer device was used for all capillary glucose measurements and a new 28G sterile lancet was used in each application. Between capillary blood glucose measurements, an average of 5 minutes was waited for pain assessment with VAS. In order to ensure the objectivity of the study, the nurse, who was trained by the researcher on the use of VAS before the study, evaluated the patient's pain at the end of each capillary blood glucose measurement by using VAS.
The data were collected by the researcher in the diabetes outpatient clinic where there is a sink for handwashing and a suitable area and equipment for blood collection. The researcher interviewed the patients who applied to the diabetes outpatient clinic, informed them about the study and obtained their written consents. After obtaining their written consents, the information of the patients was recorded in the Patient Identification Form. Then, the patients were informed about the use of the Visual Analog Scale. First, venous blood samples of the patients were collected into a tube by the researcher, and then their capillary blood samples were taken. A randomization scheme was created via the website https://www.randomizer.org/ in order to prevent bias during the evaluation of the pain felt due to drawing of capillary blood. According to this randomization order, patients were randomly assigned to one of the two groups. For capillary blood glucose measurement, two regions, fingertip and palm were used in every patient. In the first group, capillary blood glucose samples were taken first from the fingertip and then from the palm, and in the second group the capillary blood sample was first obtained from the palm and then the fingertip, and blood glucose measurements were made with the glucometer. The patient washed his/her hands with warm water and soap and dried them with a paper towel. Prior to capillary blood collection, the patient washed his/her hands with warm water, kept his hand below the level of the heart, waved downwards and gently massaged his/her fingertips in order to obtain appropriate amount of blood. The dominant hands of the patients were used to collect capillary blood samples. In order not to affect the research results, the same glucometer device was used for all capillary glucose measurements and a new 28G sterile lancet was used in each application. Between capillary blood glucose measurements, an average of 5 minutes was waited for pain assessment with VAS. In order to ensure the objectivity of the study, the nurse, who was trained by the researcher on the use of VAS before the study, evaluated the patient's pain at the end of each capillary blood glucose measurement by using VAS.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: