Needle PhobiaNCT05713539
Determining Whether There is a Change in Time Taken to Return to Homeostatic Temperature With Repeated Exposure to a Cold Stressor
A study testing Metal block in people with Needle Phobia and Needle Fear, run by The Whiteley Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Needle Phobia, Needle Fear, Injection Fear
- What is being tested?
- Metal block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2023to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give informed Consent
- Above 18 years old
Who cannot join
- Skin conditions or irregularities, or on medication that affects temperature regulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Time Taken for Skin to Return to Its Homeostatic Temperature When Exposed to Cold Conditions, and Determination of Sensitivity With Repetition
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.
Read more
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.
Read the 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.
- Conditions
- Needle Phobia, Needle Fear, Injection Fear
- Being tested
- Metal block
- Keywords
- pain, cold, skin response, injections
- Medical subject headings
- Iatrophobia, Pain, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metal blockOther
Small sheet of copper will be used when cooled to the designated temperature
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Metal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
If there is a change in response to cold, to identify how long this lasts for
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Whiteley Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Whiteley, The Whiteley Clinic
- Investigators
- Mark S Whiteley, MS FRCS (Gen) MB BS, Principal investigator, Executive Chairman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713539
- Sponsor's protocol ID
- TWC-MK-2022-12
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Time Taken for Skin to Return to Its Homeostatic Temperature When Exposed to Cold Conditions, and Determination of Sensitivity With Repetition
- ClinicalTrials.gov ID
- NCT05713539
- Acronym / sponsor ID
- TWC-MK-2022-12
- Conditions
- Needle Phobia, Needle Fear, Injection Fear
- Keywords
- pain, cold, skin response, injections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The Whiteley ClinicUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Cooled metal placed on skin | Experimental | Other: Metal blockMetal 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to give informed Consent
- Above 18 years old
Key exclusion criteria (1 listed)
- Skin conditions or irregularities, or on medication that affects temperature regulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metal blockSmall sheet of copper will be used when cooled to the designated temperature | Other | Cooled metal placed on skin |
Primary outcome
Measuring the time it takes to return to homeostatic temperature when exposed to cold.
Time frame: 1 week
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 secondary outcome
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
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No. Not planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Whiteley, MS FRCS (Gen) MB BS principal investigator
Executive Chairman
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metal block in people with Needle Phobia and Needle Fear, run by The Whiteley Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S Whiteley, MS FRCS (Gen) MB BS (03300581850, mark@thewhiteleyclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the time it takes to return to homeostatic temperature when exposed to cold. (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023; AzTrials last refreshed its copy on 4 Nov 2026.