NCT05668702

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
Last Updated

December 30, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 4, 2022

Last Update Submit

December 19, 2022

Conditions

Keywords

paincapillary blood samplingfingertipglucose

Outcome Measures

Primary Outcomes (2)

  • venous blood samples

    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

    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 Outcomes (1)

  • Visual Analog scale (VAS)

    through study completion, an average of 1 year

Study Arms (1)

capillary blood glucose measurement

EXPERIMENTAL

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

Interventions

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.

Also known as: capillary blood glucose measurement, venous blood glucose measurement, pain assessment
capillary blood glucose measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fethiye Goverment Hospital

Muğla, Fethiye, 48300, Turkey (Türkiye)

Location

Related Publications (9)

  • Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

    PMID: 11733293BACKGROUND
  • Chlebowy DO, Hood S, LaJoie AS. Facilitators and barriers to self-management of type 2 diabetes among urban African American adults: focus group findings. Diabetes Educ. 2010 Nov-Dec;36(6):897-905. doi: 10.1177/0145721710385579. Epub 2010 Oct 25.

    PMID: 20974906BACKGROUND
  • Anitha Pavithran A, Ramamoorthy L, Bs S, Murugesan R, Mj K. Comparison of Fingertip vs Palm Site Sampling on Pain Perception, and Variation in Capillary Blood Glucose Level among Patients with Diabetes Mellitus. J Caring Sci. 2020 Dec 1;9(4):182-187. doi: 10.34172/jcs.2020.028. eCollection 2020 Dec.

  • Anzalone P. Equivalence of earlobe site blood glucose testing with finger stick. Clin Nurs Res. 2008 Nov;17(4):251-61. doi: 10.1177/1054773808325050.

  • Bina DM, Anderson RL, Johnson ML, Bergenstal RM, Kendall DM. Clinical impact of prandial state, exercise, and site preparation on the equivalence of alternative-site blood glucose testing. Diabetes Care. 2003 Apr;26(4):981-5. doi: 10.2337/diacare.26.4.981.

  • Chan HY, Lau TS, Ho SY, Leung DY, Lee DT. The accuracy and acceptability of performing capillary blood glucose measurements at the earlobe. J Adv Nurs. 2016 Aug;72(8):1766-73. doi: 10.1111/jan.12944. Epub 2016 Mar 1.

  • Ergin E, Zaybak A. Effects of Different Methods Used to Take Blood Samples on Blood Glucose Measurements. Clin Nurs Res. 2022 Jan;31(1):29-38. doi: 10.1177/10547738211024782. Epub 2021 Jul 5.

  • Farmer L, Winfield C, Quatrara B, Letzkus L, Schenck P, Finneran P, Pollak D, McCaskill C, Nealy R, Conaway M. Does Site Matter? Comparing Accuracy and Patient Comfort of Blood Glucose Samples Taken From the Finger and Palm of the Perioperative Patient. J Perianesth Nurs. 2017 Dec;32(6):573-577. doi: 10.1016/j.jopan.2016.10.006. Epub 2017 Mar 22.

  • Guo J, Long Q, Li J, Wang X, Li Y, Jiang S, Sun M, Wiley J, Chen JL. Barriers and facilitators of self-monitoring of blood glucose engagement among women with gestational diabetes mellitus in China: A mixed-methods study. Midwifery. 2020 Nov;90:102797. doi: 10.1016/j.midw.2020.102797. Epub 2020 Jul 18.

MeSH Terms

Conditions

Pain

Interventions

Cross-Over Studies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Eylem Ergün, RN

    +905302373049

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2022

First Posted

December 30, 2022

Study Start

August 1, 2018

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

December 30, 2022

Record last verified: 2022-12

Locations