Cold Spray's Role in Reducing Pain During Capillary Glucose Testing

NCT ID: NCT06789055

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this clinical trial is to learn if applying a cold spray can reduce pain during capillary blood glucose measurements in adults aged 18 years or older who need at least two blood glucose tests. The main questions it aims to answer are:

Does cold spray reduce pain levels, as measured by the Visual Analogue Scale (VAS) for pain? How do pain levels compare between cold spray and placebo spray? Researchers will use a crossover design to compare a cold spray application to a placebo spray to see if there is a meaningful difference in pain reduction.

Participants will:

Receive both cold spray and placebo spray in a specific sequence Have their pain levels measured using the Visual Analogue Scale (VAS) for pain during each measurement.

Detailed Description

Background/Aim: Capillary blood glucose measurement is a common procedure in emergency departments for the assessment and management of metabolic conditions. Despite its routine nature, the skin puncture required for this procedure causes varying degrees of discomfort or pain for patients. Non-pharmacological approaches to pain management, such as the application of cold spray, offer a simple and cost-effective solution to enhance patient comfort and satisfaction. This study aims to investigate the effectiveness of cold spray in reducing pain during capillary blood glucose measurements.

Methodology:

This study is designed as a randomized controlled crossover trial. Each patient serves as their own control to minimize variability and improve the reliability of results.

Adults aged 18 years or older, who require at least two capillary blood glucose measurements for any reason and provide informed consent to participate in the study, will be included.

Patients will be randomized into two groups (details about randomisation and groups are given in the relevant section). In the intervention process: cold spray will be applied to the site of measurement from 30 cm for 10 seconds, followed by cleansing with an antimicrobial swab using a circular motion for another 10 seconds. For the placebo, sterile water will be applied in the same manner.

For both group the fingertip will then be punctured with a lancet, and the first drop of blood will be wiped away before obtaining the sample from the subsequent drop. Pain levels during the procedure will be assessed using the Visual Analog Scale (VAS), a 100-mm line ranging from "no pain" (0) to "severe pain" (100).

The primary outcome is the pain level recorded using the VAS after each capillary blood glucose measurement.

Significance: This study aims to provide evidence on the efficacy of cold spray as a non-pharmacological method to reduce pain during routine capillary blood glucose measurements. The findings may lead to improved patient comfort and satisfaction in emergency department settings, with potential implications for other routine procedures involving skin puncture.

Conditions

Visual Analog Pain Scale

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1

In the first group, placebo will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, cold spray will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement. The patient's pain level will again be evaluated using the VAS. This sequential approach allows for a direct comparison of pain scores between placebo and cold spray applications within the same patient.

Group Type: OTHER

Cold Spray

Intervention Type: OTHER

Before the capillary blood glucose measurement, cold spray will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Placebo

Intervention Type: OTHER

Before the capillary blood glucose measurement, placebo will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Group 2

In the second group, cold spray will be applied prior to the initial capillary blood glucose measurement, after which the measurement will be performed, and the patient's pain level will be assessed using the Visual Analog Scale (VAS). For the subsequent second measurement, placebo will be applied before the procedure, followed by the glucose measurement, which will be conducted on the same finger of the opposite hand as used in the first measurement.. This sequential approach allows for a direct comparison of pain scores between placebo and cold spray applications within the same patient.

Group Type: OTHER

Cold Spray

Intervention Type: OTHER

Before the capillary blood glucose measurement, cold spray will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Placebo

Intervention Type: OTHER

Before the capillary blood glucose measurement, placebo will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Interventions

Cold Spray

Before the capillary blood glucose measurement, cold spray will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Intervention Type: OTHER

Placebo

Before the capillary blood glucose measurement, placebo will be applied to the measurement site from a distance of 30 cm for 10 seconds. Following this, the area will be cleansed with an antimicrobial swab for 10 seconds using a circular motion, starting from the center and moving outward. Subsequently, the fingertip will be punctured with a lancet to obtain a blood sample. The first drop of blood will be wiped away with cotton, and the glucose measurement will be performed using the subsequent drop utilizing the Standard GlucoNavii GDH device. The patient will then be asked to assess their pain during the procedure using the Visual Analog Scale (VAS) for pain evaluation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥18 years
• Patients requiring at least two capillary blood glucose measurements for any reason
• Patients who agree to participate in the study

Exclusion Criteria

• Allergy to the components of the spray
• Conditions that may affect capillary blood glucose measurement or pain perception, such as peripheral neuropathy or peripheral arterial disease
• Blood glucose levels outside the measurable range of the capillary device (extremely low or high levels)
• Cognitive disorders that prevent the evaluation of the Visual Analog Scale (VAS), such as dementia, Alzheimer's disease, or cerebrovascular diseases
• Severe conditions in other parts of the body that may interfere with pain evaluation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Faruk Danış, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bolu Abant Izzet Baysal University

Bolu, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Faruk Danış, Assistant Professor

Role: CONTACT

farukdanis@gmail.com

+905055864962

Emre Kudu, MD

Role: CONTACT

dr.emre.kudu@gmail.com

+905067613610

Facility Contacts

Faruk Danış, Assistant Professor

Role: primary

farukdanis@gmail.com

+905055864962

Faruk Danış, Assistant Professor

Role: backup

Other Identifiers

BAIBU-TF-FD-01

Identifier Type: -

Identifier Source: org_study_id