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

NCT06789055 | Completed

• 1 other identifier: BAIBU-TF-FD-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Capillary blood glucose measurement is a routine procedure in emergency departments, but it may cause pain and discomfort because it requires fingertip puncture. Vapocoolant spray is a rapid, noninvasive, and inexpensive method of topical analgesia that may reduce pain during minor procedures. However, its effectiveness during capillary blood glucose testing has not been sufficiently studied. This study aims to evaluate whether vapocoolant spray reduces pain during capillary blood glucose measurement compared with placebo in adult emergency department patients requiring at least two clinically indicated glucose measurements. In this randomized, placebo-controlled crossover trial, participants receive both vapocoolant spray and placebo in a randomized sequence before two separate capillary glucose measurements. Pain is assessed immediately after each procedure using a 100 mm Visual Analog Scale. The findings may help inform practical strategies to improve patient comfort during routine glucose testing in emergency care settings.

Conditions

Visual Analog Pain Scale

Keywords

Vapocoolant Spray; Capillary Glucose Testing; Pain Management; Patient Comfort

Outcome Measures

Primary Outcomes (1)

• Visual Analog Pain Scale

  The primary outcome of this study is the Visual Analog Scale (VAS) score for pain. The VAS is a widely used assessment tool to evaluate variables across a continuum, such as acute pain severity. For the purpose of this study, patients will be presented with a 100-mm line, where one end is labeled "no pain" and the other end is labeled "severe pain." After each capillary blood glucose measurement, patients will be asked to mark their level of pain on the VAS line based on their experience during the procedure. The VAS score will be determined by measuring the distance in millimeters from the "no pain" end to the point marked by the patient. This standardized and validated method provides a quantitative measure of pain that is both simple and reliable for clinical use.

  Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.

Study Arms (2)

Placebo, Then Vapocoolant Spray

OTHER

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, Vapocoolant 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 Vapocoolant spray applications within the same patient.

Other: Vapocoolant Spray; Other: Placebo

Vapocoolant Spray, Then Placebo

OTHER

In the second group, Vapocoolant 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 Vapocoolant spray applications within the same patient.

Other: Vapocoolant Spray; Other: Placebo

Interventions

Placebo 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.

Placebo, Then Vapocoolant Spray; Vapocoolant Spray, Then Placebo

Vapocoolant Spray OTHER

Before the capillary blood glucose measurement, vapocoolant 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, Then Vapocoolant Spray; Vapocoolant Spray, Then Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University

Bolu, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The random allocation sequence was generated by an investigator not involved in direct patient care. Participants were randomized into two sequence groups using an online randomization tool with block randomization. A fixed block size of four was used to ensure balanced allocation between groups. Following randomization, group assignments were placed in sequentially numbered, opaque, sealed envelopes. To ensure blinding, both the vapocoolant spray and placebo containers were wrapped in opaque white paper to conceal their contents and labeled only as "1" or "2" according to the assigned sequence. Apart from these numerical labels, the containers were identical in appearance. This labeling procedure was performed by an individual who was not involved in patient care, outcome assessment, or data analysis. Thus, both participants and the care providers administering the spray remained blinded to the intervention type.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study was designed as a randomized crossover trial. Patients requiring at least two capillary blood glucose measurements were included in the study. Participants were randomized into two groups. In the first group, placebo was applied during the first measurement, and vapocoolant spray was used for the second measurement. Conversely, in the second group, vapocoolant spray was applied prior to the first glucose measurement, followed by placebo during the second measurement. This crossover design ensures that each patient serves as their own control, minimizing inter-individual variability and enhancing the reliability of the findings.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: March 10, 2025
• Primary Completion: March 14, 2025
• Study Completion: March 14, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)