Visual Analog Pain Scale
Conditions
Keywords
Vapocoolant Spray, Capillary Glucose Testing, Pain Management, Patient Comfort
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.
Detailed description
This study is a single-center, randomized, placebo-controlled crossover trial conducted in the emergency department of a tertiary care hospital. The study evaluates the efficacy of vapocoolant spray in reducing pain during capillary blood glucose measurement in adult patients who require at least two clinically indicated capillary glucose measurements during the same emergency department visit. Capillary blood glucose testing is frequently performed in emergency care and is essential for the evaluation and management of many patients. Although it is considered a minor procedure, repeated fingertip punctures may cause pain, discomfort, and procedure-related distress. Vapocoolant spray produces rapid skin cooling and may provide short-term cutaneous analgesia through temporary reduction of sensory nerve conduction. While vapocoolants have been studied in other needle-related procedures, evidence for their use during capillary blood glucose testing remains limited. Eligible participants are adults aged 18 years or older who require at least two capillary blood glucose measurements for any clinical indication and who provide informed consent. Participants are randomized to one of two intervention sequences. In one sequence, placebo spray is applied before the first capillary blood glucose measurement and vapocoolant spray is applied before the second measurement. In the other sequence, vapocoolant spray is applied before the first measurement and placebo spray is applied before the second. The second measurement is performed on the corresponding finger of the contralateral hand according to the assigned sequence. No additional punctures beyond those clinically indicated are performed. Vapocoolant spray containing ethyl chloride is applied from a distance of 30 cm for 10 seconds before the procedure. The placebo consists of sterile water spray applied in the same manner. After spray application, the site is cleansed according to the standard protocol, the fingertip is punctured with a standard lancet, and capillary blood glucose measurement is performed using the study device. The primary outcome is pain intensity during capillary blood glucose measurement, assessed immediately after each procedure using a 100 mm Visual Analog Scale. Secondary outcomes include adverse events related to spray application, such as pruritus, coolness, numbness, erythema, or burning sensation. The crossover design allows each participant to serve as their own control, thereby reducing interindividual variability in pain perception. Randomization of intervention order is used to minimize potential sequence and acclimatization effects associated with repeated glucose measurements. The results of this study may support the use of a simple and practical analgesic strategy to improve patient comfort during routine capillary blood glucose testing in emergency department practice.
Interventions
OTHERVapocoolant Spray
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.
OTHERPlacebo
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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Scale | Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure. | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed