Pain ManagementNCT06378424
The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization
A study testing Cold Application, Heat Application and Vibration Application in people with Pain Management and Emergency Unit, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management, Emergency Unit, Diarrhea
- What is being tested?
- Cold Application, Heat Application and Vibration Application
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2023to 23 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being in accordance with time and place
- Being aged between 18 and 65 years
- Being able to evaluate the visual analog scale correctly
- Participating voluntarily in the research.
Who cannot join
- Not participating voluntarily in the research
- Not fitting the inclusion criteria of the research
- Having a vision or hearing problem
- Having a mastectomy
- Having any illness which could affect pain perception, such as sensory-motor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
- Having an allergy to heat and cold application
- Having phlebitis, scar tissue, dermatitis, an incision or findings of infection at the place where the intervention was to be performed
- Having taken an analgesic (within the previous six hours) or an anesthetic agent before the peripheral intravenous catheterization procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Uludag University Hospital
Bursa, Nilüfer
About this study
Official title: The Effectiveness of Local Dry Cold, Hot and Vibration Applications During Peripheral Intravenous Catheterization Placement in the Emergency Unit
Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.
Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale.
- Conditions
- Pain Management, Emergency Unit, Diarrhea, Nausea, Vomiting
- Being tested
- Cold Application, Heat Application, Vibration Application
- Keywords
- Hot application, cold application, peripheral intravenous catheterization, venous dilation, pain, vibration
- Medical subject headings
- Agnosia, Emergencies, Diarrhea, Nausea, Vomiting, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold ApplicationOther
Before peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use.
Heat ApplicationOther
Before peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use.
Vibration ApplicationOther
With individuals in this group, the Buzzy® device was used to provide vibration. The Buzzy® device, at room temperature, was placed by the researcher on the peripheral intravenous catheterization application area before the application was performed. For one minute before the application, a slight, non-discomforting vibration was applied to the intervention area. As the Buzzy® device can be used more than once, it was disinfected after each use and before being used with another individual. In this study, the body of the device was used, and only vibration was applied to the individuals in this group.
| Study group | Role | What they receive |
|---|---|---|
| Cold Application Group | Experimental | Before peripheral intravenous catheterization, dry cold was applied to the application area using a cold gel pack. For this purpose, a 11 x10 cm pack of non-toxic gel was frozen solid in the refrigerator. Because this pack is reusable, it was disinfected before and after each use, and left in the service refrigerator to freeze solid. Attention was paid that it was used in solid form with all individuals. Receives: Other: Cold Application |
| Heat Application Group | Experimental | Before peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use. Receives: Other: Heat Application |
| Vibration Application Group | Experimental | With individuals in this group, device was used to provide vibration. The device, at room temperature, was placed by the researcher on the peripheral intravenous catheterization application area before the application was performed. For one minute before the application, a slight, non-discomforting vibration was applied to the intervention area. Receives: Other: Vibration Application |
| The control group | No intervention | No intervention was performed on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity in mm
A 10-cm vertical VAS was used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible. Pain severity was evaluated in millimeters.
Measured: 6 months
venous dilation in score
Vein Assessment Scale was used in the study to evaluate individuals' veins. There are five 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: 6 months
procedure duration in sec
In the stages of the peripheral intravenous catheterization intervention of individuals in the application and control groups, a chronometer was started immediately after an automatic tourniquet was attached to the patient's arm. After catheterization was completed successfully and before the evaluation material was applied, the chronometer was stopped, and the procedure duration was recorded in the form of seconds on the data collection form.
Measured: 6 months
Secondary outcomes (2)
weight
weight in kilograms
Measured: 6 months
height
height in meters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start22 Mar 2023
- Primary completion22 Mar 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Yilmaz, PhD, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378424
- Sponsor's protocol ID
- 2023-6/6
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yilmaz E, Yilmaz D. The effect of three different nonpharmacological methods on cannulation success during peripheral intravenous catheter placement in the emergency unit: a randomized controlled trial. BMC Anesthesiol. 2024 Oct 9;24(1):362. doi: 10.1186/s12871-024-02723-2.
PubMed 39385099
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Local Dry Cold, Hot and Vibration Applications During Peripheral Intravenous Catheterization Placement in the Emergency Unit
- ClinicalTrials.gov ID
- NCT06378424
- Acronym / sponsor ID
- 2023-6/6
- Conditions
- Pain Management, Emergency Unit, Diarrhea, Nausea, Vomiting
- Keywords
- Hot application, cold application, peripheral intravenous catheterization, venous dilation, pain, vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 22 Apr 2024 (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.
Aim: The aim of the present study was to examine the effect on venous dilation, procedure duration and pain severity of local hot, cold and vibration applications performed on the intervention area before peripheral intravenous catheterization in adults.
Methods: The study included 120 adults who were randomly selected between March and August 2023. One application group (n=30) received local hot application, one group (n=30) received local cold application, and one (n=30) received local vibration using the Buzzy® device. The applications, to the site of the peripheral intravenous catheterization, lasted one minute. The control group (n=30) the received standard peripheral intravenous catheterization application. The groups' venous dilation was assessed on the vein assessment scale and the level of pain felt during catheterization was assessed using a visual analog scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cold Application Group | Experimental | Other: Cold ApplicationBefore peripheral intravenous catheterization, dry cold was applied to the application area using a cold gel pack. For this purpose, a 11 x10 cm pack of non-toxic gel was frozen solid in the refrigerator. Because this pack is reusable, it was disinfected before and after each use, and left in the service refrigerator to freeze solid. Attention was paid that it was used in solid form with all individuals. |
| Heat Application Group | Experimental | Other: Heat ApplicationBefore peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use. |
| Vibration Application Group | Experimental | Other: Vibration ApplicationWith individuals in this group, device was used to provide vibration. The device, at room temperature, was placed by the researcher on the peripheral intravenous catheterization application area before the application was performed. For one minute before the application, a slight, non-discomforting vibration was applied to the intervention area. |
| The control group | No intervention | –No intervention was performed on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure was performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being in accordance with time and place
- Being aged between 18 and 65 years
- Being able to evaluate the visual analog scale correctly
- Participating voluntarily in the research.
Key exclusion criteria (8 listed)
- Not participating voluntarily in the research
- Not fitting the inclusion criteria of the research
- Having a vision or hearing problem
- Having a mastectomy
- Having any illness which could affect pain perception, such as sensory-motor disorder, diabetes, peripheral vascular diseases or peripheral neuropathy
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 |
|---|---|---|
| Cold ApplicationBefore peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use. | Other | Cold Application Group |
| Heat ApplicationBefore peripheral intravenous catheterization, heat of approximately 40-42 o C was applied for 1 minute to the area of the procedure using a hot pack, which is one of the dry heat application methods. The heat application pack has a feature that it can maintain its temperature when taken out of hot water and does not disturb the person when it comes into direct contact with the skin. In order to apply heat to the individuals in this group, a pack of 11 x 19 cm is used. This pack is covered with cloth and contains a non-toxic gel, and is placed in hot water to prepare it for use. Because this pack is reusable, it was disinfected before and after each use. | Other | Heat Application Group |
| Vibration ApplicationWith individuals in this group, the Buzzy® device was used to provide vibration. The Buzzy® device, at room temperature, was placed by the researcher on the peripheral intravenous catheterization application area before the application was performed. For one minute before the application, a slight, non-discomforting vibration was applied to the intervention area. As the Buzzy® device can be used more than once, it was disinfected after each use and before being used with another individual. In this study, the body of the device was used, and only vibration was applied to the individuals in this group. | Other | Vibration Application Group |
Primary outcome
pain intensity in mm
Time frame: 6 months
A 10-cm vertical VAS was used to evaluate the severity of pain felt by the individuals during the procedure. One end indicated lack of pain and the other the most severe pain possible. Pain severity was evaluated in millimeters.
venous dilation in score
Time frame: 6 months
Vein Assessment Scale was used in the study to evaluate individuals' veins. There are five 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.
procedure duration in sec
Time frame: 6 months
In the stages of the peripheral intravenous catheterization intervention of individuals in the application and control groups, a chronometer was started immediately after an automatic tourniquet was attached to the patient's arm. After catheterization was completed successfully and before the evaluation material was applied, the chronometer was stopped, and the procedure duration was recorded in the form of seconds on the data collection form.
2 secondary outcomes
weight
Time frame: 6 months
height
Time frame: 6 months
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 22 Apr 2024.
- Derived from this study: PubMed 39385099Yilmaz E, Yilmaz D. The effect of three different nonpharmacological methods on cannulation success during peripheral intravenous catheter placement in the emergency unit: a randomized controlled trial. BMC Anesthesiol. 2024 Oct 9;24(1):362. doi: 10.1186/s12871-024-02723-2.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application, Heat Application and Vibration Application in people with Pain Management and Emergency Unit, run by Uludag 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 4 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 22 Apr 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 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?
pain intensity in mm (time frame: 6 months). The study lists 3 primary outcomes in all. 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 NCT06378424, which also lists 1 linked publication.
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 22 Apr 2024.