Clinical trial NCT06789055: Cold Spray's Role in Reducing Pain During Capillary Glucose Testing
Official title: Efficacy of a Cold Spray in Reducing Pain During Capillary Glucose Testing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Visual Analog Pain Scale
Keywords: Cold Spray
Capillary Glucose Testing
Pain Management
Patient Comfort
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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 cold spray was used for the second measurement. Conversely, in the second group, cold 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Immediately after blood glucose measurement, assessed within the first 5 minutes after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University
Study officials:
References: