Blood Glucose Measurement in Terms Ofg Pain and Result Consistency

Sponsor
Melek Sahin (Other)
Overall Status
Completed
CT.gov ID
NCT05668702
Collaborator
(none)
130
1
1
4
32.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: crossover design
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
130 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
crossover designcrossover design
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
A Comparison of Two Regions Used in Capillary Blood Glucose Test in Terms of Pain and Result Consistency
Actual Study Start Date :
Aug 1, 2018
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. venous blood samples [through study completion, an average of 1 year]

      Venous blood samples of the patients were collected into a tube by the researcher.

    2. Capillary blood glucose measurement [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.

    Secondary Outcome Measures

    1. Visual Analog scale (VAS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fethiye Goverment Hospital Muğla Fethiye Turkey 48300

    Sponsors and Collaborators

    • Melek Sahin

    Investigators

    • Study Director: Eylem Ergün, RN, +905302373049

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Melek Sahin, Principal Investigator, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT05668702
    Other Study ID Numbers:
    • 05.04.2018 04/I
    First Posted:
    Dec 30, 2022
    Last Update Posted:
    Dec 30, 2022
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Melek Sahin, Principal Investigator, Muğla Sıtkı Koçman University

    Study Results

    No Results Posted as of Dec 30, 2022