Study of Ice Application to Reduce Pain From Arterial Punctures
Primary Purpose
Vessel Puncture Site Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy (ice pack)
Sponsored by
About this trial
This is an interventional supportive care trial for Vessel Puncture Site Pain focused on measuring ice, cryotherapy, puncture, pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- St. Joseph Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cryotherapy
Control
Arm Description
Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes
Cryotherapy is not applied to the radial artery puncture area
Outcomes
Primary Outcome Measures
pain
Pain is measured with a 100 mm visual analog scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02065115
First Posted
February 14, 2014
Last Updated
February 17, 2014
Sponsor
St. Joseph Hospital, New Hampshire
1. Study Identification
Unique Protocol Identification Number
NCT02065115
Brief Title
Study of Ice Application to Reduce Pain From Arterial Punctures
Official Title
Cryoanalgesia (Ice Pack) to Reduce the Pain Associated With Arterial Blood Gas Puncture
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Joseph Hospital, New Hampshire
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study seeks to determine if cryoanalgesia in the form of ice application could be an effective analgesic when applied before arterial puncture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vessel Puncture Site Pain
Keywords
ice, cryotherapy, puncture, pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
Cryotherapy: 12 ounces of crushed ice place in a plastic bag applied to the radial artery puncture area for 3 minutes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Cryotherapy is not applied to the radial artery puncture area
Intervention Type
Other
Intervention Name(s)
Cryotherapy (ice pack)
Primary Outcome Measure Information:
Title
pain
Description
Pain is measured with a 100 mm visual analog scale
Time Frame
1-5 minutes after arterial puncture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey m Haynes, RRT RPFT
Organizational Affiliation
St. Joseph Hospital, Nashua New Hampshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph Hospital
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8989058
Citation
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.
Results Reference
background
PubMed Identifier
25516991
Citation
Haynes 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.
Results Reference
derived
Learn more about this trial
Study of Ice Application to Reduce Pain From Arterial Punctures
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