Vessel Puncture Site PainNCT02065115
Study of Ice Application to Reduce Pain From Arterial Punctures
A study testing Cryotherapy (ice pack) in people with Vessel Puncture Site Pain, run by St. Joseph Hospital, New Hampshire at 1 site in United States.
Trial summary
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Vessel Puncture Site Pain
- What is being tested?
- Cryotherapy (ice pack)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Oct 2013
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects ≥ 18 years old referred to the pulmonary function laboratory with a physician order for an arterial blood gas test were sought to complete the study
Who cannot join
- cold, bluish hands and fingers
- diagnosis of Raynaud's syndrome or scleroderma/CREST syndrome
- history or signs of dementia, confusion, or cognitive impairment
- blindness
- patients not fluent in the English language
- non-palpable radial pulse in the wrist (necessitating brachial puncture)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cryoanalgesia (Ice Pack) to Reduce the Pain Associated With Arterial Blood Gas Puncture
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.
- Conditions
- Vessel Puncture Site Pain
- Being tested
- Cryotherapy (ice pack)
- Keywords
- ice, cryotherapy, puncture, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy (ice pack)Other
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes Receives: Other: Cryotherapy (ice pack) |
| Control | No intervention | Cryotherapy is not applied to the radial artery puncture area |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain related to arterial puncture
Pain is measured with a 100 mm visual analog scale
Measured: 1-5 minutes after arterial puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vessel Puncture Site PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital, New Hampshire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey m Haynes, RRT RPFT, Principal investigator, St. Joseph Hospital, Nashua New Hampshire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065115
- Sponsor's protocol ID
- SJH IRB 2012-05
- Status last verified
- Nov 2024
- First submitted
- 14 Feb 2014
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Giner J, Casan P, Belda J, Gonzalez M, Miralda RM, Sanchis J. Pain during arterial puncture. Chest. 1996 Dec;110(6):1443-5. doi: 10.1378/chest.110.6.1443.
PubMed 8989058Haynes JM. Randomized controlled trial of cryoanalgesia (ice bag) to reduce pain associated with arterial puncture. Respir Care. 2015 Jan;60(1):1-5. doi: 10.4187/respcare.03312. Epub 2014 Dec 16.
PubMed 25516991
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoanalgesia (Ice Pack) to Reduce the Pain Associated With Arterial Blood Gas Puncture
- ClinicalTrials.gov ID
- NCT02065115
- Acronym / sponsor ID
- SJH IRB 2012-05
- Conditions
- Vessel Puncture Site Pain
- Keywords
- ice, cryotherapy, puncture, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- St. Joseph Hospital, New HampshireUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Feb 2014 (estimated)
- 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.
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Other: Cryotherapy (ice pack)Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes |
| Control | No intervention | –Cryotherapy is not applied to the radial artery puncture area |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects ≥ 18 years old referred to the pulmonary function laboratory with a physician order for an arterial blood gas test were sought to complete the study
Key exclusion criteria (6 listed)
- cold, bluish hands and fingers
- diagnosis of Raynaud's syndrome or scleroderma/CREST syndrome
- history or signs of dementia, confusion, or cognitive impairment
- blindness
- patients not fluent in the English language
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 |
|---|---|---|
| Cryotherapy (ice pack) | Other | Cryotherapy |
Primary outcome
pain related to arterial puncture
Time frame: 1-5 minutes after arterial puncture
Pain is measured with a 100 mm visual analog scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 8989058Giner J, Casan P, Belda J, Gonzalez M, Miralda RM, Sanchis J. Pain during arterial puncture. Chest. 1996 Dec;110(6):1443-5. doi: 10.1378/chest.110.6.1443.
- Derived from this study: PubMed 25516991Haynes JM. Randomized controlled trial of cryoanalgesia (ice bag) to reduce pain associated with arterial puncture. Respir Care. 2015 Jan;60(1):1-5. doi: 10.4187/respcare.03312. Epub 2014 Dec 16.
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.
Jeffrey m Haynes, RRT RPFT principal investigator
St. Joseph Hospital, Nashua New Hampshire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy (ice pack) in people with Vessel Puncture Site Pain, run by St. Joseph Hospital, New Hampshire at 1 site in United States.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2024. 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain related to arterial puncture (time frame: 1-5 minutes after arterial puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065115, which also lists 2 linked publications.
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 29 Nov 2024.