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Determining Whether There is a Change in Time Taken to Return to Homeostatic Temperature With Repeated Exposure to a Cold Stressor

Identification of the Time Taken for Skin to Return to Its Homeostatic Temperature When Exposed to Cold Conditions, and Determination of Sensitivity With Repetition

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05713539
Enrollment
5
Registered
2023-02-06
Start date
2023-02-28
Completion date
2023-02-28
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Fear, Needle Fear, Needle Phobia

Keywords

pain, cold, skin response, injections

Brief summary

There has been previous research suggesting cold has an effect on pain relief, however there is limited knowledge on the relationship between exposure time of a cold stressor and how long it takes to return to homeostatic temperature and normal response to cold, in addition to whether location site affects this. The skin's thermal response to a cold stimulus is not fully understood. This provides precedent for potentially using cold stressors as a way to provide pain free injections. 5 participants will be exposed to a block of copper on the skin at -2°C for 30 seconds, and a thermal camera will be used to identify the amount of time it takes for the skin to return to its homeostatic temperature. The participant will then be left for 30 seconds before the experiment is repeated to identify if there is a change in the response to cold after the first exposure. If increased sensitivity in the response to cold occurs, the experiment will be repeated by adding an additional 30 seconds between repeats to identify the minimum time required between exposures that doesn't result in increased sensitivity. This will occur until there are two consecutive times with no increased sensitivity. This will occur on both the forehead and on the deltoid of the arm, two areas where injections are common. The cold stressor will be block of copper metal which will be cooled to this temperature.

Detailed description

A thermal imaging camera is used to identify the 'normal' temperature of the skin on the forehead. A cooled block of copper is then placed onto the skin of the forehead at a temperature of -2°C for 30 seconds. A timer is then used to measure how long it takes for the skin on the forehead to return to its normal temperature. This is then repeated twice with a minute in between each measurement to identify if there is a change in the response to cold, where it takes more/less time to return to normal levels. If the time taken to return to normal changes, the participant will be given 30 minutes to rest, and then repeat the experiment with an additional minute between repeats. This will continue until there is no change in the amount of time it takes for the skin to return to normal on the forehead once exposed to the cold conditions to identify a sensitivity time due to a change in the response to cold. This will be tested on 5 patients. This will also be tested on the outer deltoid, where injections usually occur in your arm.

Interventions

OTHERMetal block

Small sheet of copper will be used when cooled to the designated temperature

Sponsors

The Whiteley Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Metal placed onto skin at -2 degrees celsius for 30 seconds, and then timed on how long it takes for the skin to return to normal levels, measured using a thermal imaging camera

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Able to give informed Consent * Above 18 years old

Exclusion criteria

* Skin conditions or irregularities, or on medication that affects temperature regulation

Design outcomes

Primary

MeasureTime frameDescription
Measuring the time it takes to return to homeostatic temperature when exposed to cold.1 weekTo identify if there is sensitivity (change in response to cold) between repeats when a cold stressor when placed onto the skin which changes the amount of time it takes for the skin to return to its normal temperature

Secondary

MeasureTime frameDescription
To calculate the length of normal response time of skin to cold by looking at time it takes to return to homeostatic temperature in response to multiple cold exposures1 weekIf there is a change in response to cold, to identify how long this lasts for

Countries

United Kingdom

Contacts

Primary ContactMark S Whiteley, MS FRCS (Gen) MB BS
mark@thewhiteleyclinic.co.uk03300581850
Backup ContactMelissa J Kiely, BSc (Hons)
melissa.kiely@thewhiteleyclinic.co.uk01483544960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026