Peripheral Venous CatheterizationNCT04177745
Hot and Cold Applications on PVC Insertion
A study testing Hot application and Cold application in people with Peripheral Venous Catheterization, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Venous Catheterization
- What is being tested?
- Hot application and Cold application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2018to 29 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being able to speak and understand Turkish,
- being over 18 years of age,
- having unimpaired sense of time or place orientation,
- having no psychiatric disorders,
- having no visual or hearing problem,
- having indication of IV catheter application,
Show all 10Show fewer
- having no administration of analgesic or anaesthetic agents prior to IV catheter insertion,
- having catheter inserted in one attempt,
- having no allergy to hot and cold applications,
- being voluntary to participate in the study.
Who cannot join
- infection
- previous history of surgery,
- scarring in the catheter insertion site,
- psoriasis in the catheter insertion site,
- active dermatitis in the catheter insertion site,
- peripheral nerve disease,
- diabetes,
- peripheral neuropathy in the catheter insertion site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Local Hot and Cold Applications on Peripheral Intravenous Catheters: A Randomised Control Trial
Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.
Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. PVC was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.
Read the detailed description
Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.
Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. The sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the Cardiology Clinic between November and December 2018.
- Conditions
- Peripheral Venous Catheterization
- Being tested
- Hot application, Cold application
- Keywords
- Peripheral venous catheter, hot application, cold application, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hot applicationOther
Before PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute.
Cold applicationOther
Before PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute.
| Study group | Role | What they receive |
|---|---|---|
| Hot Application | Experimental | Before PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm. Receives: Other: Hot application |
| Cold Application | Experimental | Before PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm. Receives: Other: Cold application |
| Standard Practice | No intervention | The standard practice of the clinic was made. Accordingly, the researcher performed the vein assessment after the participants filled out the questionnaire, and then inserted the 20-G catheter into the inner surface of their forearm without any application. Afterwards, she assessed the pain and anxiety levels of the patients twice before and after the catheter insertion procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for pain and anxiety
The number "0" on the scale means that they do not feel any pain / anxiety and the number "10" refers to the worst pain and the highest level of anxiety.
Measured: Before catheter insertion
Vein Assessment Scale
There are 5 assessment steps: (1) veins are neither visible nor palpable, (2) veins are visible but not palpable, (3) veins are barely visible and palpable, (4) veins are visible and palpable, and (5) veins are clearly visible and easily palpable
Measured: Before hot/cold application
Secondary outcomes (2)
Numeric Rating Scale for pain and anxiety
The number "0" on the scale means that they do not feel any pain / anxiety and the number "10" refers to the worst pain and the highest level of anxiety.
Measured: During catheter insertion
Vein Assessment Scale
There are 5 assessment steps: (1) veins are neither visible nor palpable, (2) veins are visible but not palpable, (3) veins are barely visible and palpable, (4) veins are visible and palpable, and (5) veins are clearly visible and easily palpable
Measured: Immediately before insertion of the catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start20 Nov 2018
- Primary completion20 Nov 2018
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Venous CatheterizationStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Korkut, TC Erciyes University
- Investigators
- Sevda Korkut, Ph.D, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177745
- Sponsor's protocol ID
- 444
- Status last verified
- Aug 2020
- First submitted
- 22 Nov 2019
- Last updated
- 31 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Local Hot and Cold Applications on Peripheral Intravenous Catheters: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04177745
- Acronym / sponsor ID
- 444
- Conditions
- Peripheral Venous Catheterization
- Keywords
- Peripheral venous catheter, hot application, cold application, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 26 Nov 2019 (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.
Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.
Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. PVC was inserted, the researcher applied a hot or cold application to the catheter insertion site for one minute.
Detailed description
Background: This study was conducted to examine the effect of local hot and cold applications on pain, anxiety level, length of application, and vein evaluation prior to inserting PVC.
Methods: This randomised controlled trial was conducted with patients who were hospitalised in the cardiology department of a university hospital. The sample was comprised of 90 individuals, including 30 in the cold application group, 30 in the hot application group, and 30 in the control group receiving treatment in the Cardiology Clinic between November and December 2018.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hot Application | Experimental | Other: Hot applicationBefore PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm. |
| Cold Application | Experimental | Other: Cold applicationBefore PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute. Then, the researcher made the second vein assessment and inserted a 20-G peripheral catheter into the inner surface of the forearm. |
| Standard Practice | No intervention | –The standard practice of the clinic was made. Accordingly, the researcher performed the vein assessment after the participants filled out the questionnaire, and then inserted the 20-G catheter into the inner surface of their forearm without any application. Afterwards, she assessed the pain and anxiety levels of the patients twice before and after the catheter insertion procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- being able to speak and understand Turkish,
- being over 18 years of age,
- having unimpaired sense of time or place orientation,
- having no psychiatric disorders,
- having no visual or hearing problem,
Key exclusion criteria (8 listed)
- infection
- previous history of surgery,
- scarring in the catheter insertion site,
- psoriasis in the catheter insertion site,
- active dermatitis in the catheter insertion site,
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 |
|---|---|---|
| Hot applicationBefore PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute. | Other | Hot Application |
| Cold applicationBefore PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute. | Other | Cold Application |
Primary outcome
Numeric Rating Scale for pain and anxiety
Time frame: Before catheter insertion
The number "0" on the scale means that they do not feel any pain / anxiety and the number "10" refers to the worst pain and the highest level of anxiety.
Vein Assessment Scale
Time frame: Before hot/cold application
There are 5 assessment steps: (1) veins are neither visible nor palpable, (2) veins are visible but not palpable, (3) veins are barely visible and palpable, (4) veins are visible and palpable, and (5) veins are clearly visible and easily palpable
2 secondary outcomes
Numeric Rating Scale for pain and anxiety
Time frame: During catheter insertion
Vein Assessment Scale
Time frame: Immediately before insertion of the catheter
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 31 Aug 2020.
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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.
Sevda Korkut, Ph.D principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hot application and Cold application in people with Peripheral Venous Catheterization, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 10 inclusion and 8 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 31 Aug 2020. 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 Turkey (Türkiye). 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?
Numeric Rating Scale for pain and anxiety (time frame: Before catheter insertion). The study lists 2 primary outcomes in all. 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 31 Aug 2020.