Blood Glucose Measurement in Terms Ofg Pain and Result Consistency

December 19, 2022 updated by: Melek Sahin

A Comparison of Two Regions Used in Capillary Blood Glucose Test in Terms of Pain and Result Consistency

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fethiye
      • Muğla, Fethiye, Turkey, 48300
        • Fethiye Goverment Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals with Type 2 diabetes
  • who fasted at least 8-12 hours before blood sampling,
  • who were 18 years and older,
  • volunteered to participate in the study

Exclusion Criteria:

  • with mental problems,
  • communication problems,
  • vision problems,
  • upper extremity amputations,
  • peripheral neuropathy or decreased sensation in their hands,
  • the ones in whom blood samples cannot be obtained from the arm veins due to plaster etc.,
  • those who could not make the Visual Analog Scale (VAS) correctly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: capillary blood glucose measurement
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.
Other: crossover design
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.
Other Names:
  • capillary blood glucose measurement
  • venous blood glucose measurement
  • pain assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
venous blood samples
Time Frame: through study completion, an average of 1 year
Venous blood samples of the patients were collected into a tube by the researcher.
through study completion, an average of 1 year
Capillary blood glucose measurement
Time Frame: through study completion, an average of 1 year
For capillary blood glucose measurement, two regions, fingertip and palm were used in every patient. 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog scale (VAS)
Time Frame: through study completion, an average of 1 year

At the end of each capillary blood glucose measurement, the patient's pain was assessed using the VAS.

Visual Analog scale (VAS) is a one-dimensional scale used to measure pain. The scale consists of a 100 mm long line, with the words "painlessness" on one end and "the most severe pain" on the other end. "0" denotes painlessness, "100" denotes the most severe pain. The scale can be used horizontally or vertically. In this study, VAS was used horizontally.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melek Sahin

Investigators

  • Study Director: Eylem Ergün, RN, +905302373049

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

November 30, 2018

Study Registration Dates

First Submitted

December 4, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

December 30, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05.04.2018 04/I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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