The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization
1 other identifier
interventional
120
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2023
CompletedFirst Submitted
Initial submission to the registry
April 18, 2024
CompletedFirst Posted
Study publicly available on registry
April 22, 2024
CompletedApril 22, 2024
April 1, 2024
Same day
April 18, 2024
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
6 months
Secondary Outcomes (2)
weight
6 months
height
6 months
Study Arms (4)
Cold Application Group
EXPERIMENTALBefore 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
EXPERIMENTALBefore 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
EXPERIMENTALWith 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 INTERVENTIONNo intervention was performed on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure was performed.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not participating voluntarily in 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Uludag University Hospital
Bursa, Nilüfer, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 39385099DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Bursa Uludag University, Department of Nursing
Study Record Dates
First Submitted
April 18, 2024
First Posted
April 22, 2024
Study Start
March 22, 2023
Primary Completion
March 22, 2023
Study Completion
August 23, 2023
Last Updated
April 22, 2024
Record last verified: 2024-04