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

NCT05713539 | Unknown

• 1 other identifier: TWC-MK-2022-12
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Needle Phobia; Needle Fear; Injection Fear

Keywords

pain; cold; skin response; injections

Outcome Measures

Primary Outcomes (1)

• Measuring the time it takes to return to homeostatic temperature when exposed to cold.

  To 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

  1 week

Secondary Outcomes (1)

• 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 exposures

  1 week

Study Arms (1)

Cooled metal placed on skin

EXPERIMENTAL

Metal is placed onto the skin at a temperature of -2 degrees Celsius for 30 seconds. A thermal imaging camera will be used to identify how long it takes for the skin to return to its initial temperature.

Other: Metal block

Interventions

Metal block OTHER

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

Cooled metal placed on skin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give informed Consent
• Above 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• The Whiteley Clinic: lead

Study Sites (1)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

Location

MeSH Terms

Conditions

Iatrophobia; Pain; Common Cold

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Mark S Whiteley, MS FRCS (Gen) MB BS

  Executive Chairman

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark S Whiteley, MS FRCS (Gen) MB BS

CONTACT

03300581850; mark@thewhiteleyclinic.co.uk

Melissa J Kiely, BSc (Hons)

CONTACT

01483544960; melissa.kiely@thewhiteleyclinic.co.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Venous Surgeon

Model Details: 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

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 6, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)