The Effectiveness of Local Dry Cold, Hot and Vibration Applications in Peripheral Intravenous Catheterization

Diarrhea Clinical Trial

Official title:

The Effectiveness of Local Dry Cold, Hot and Vibration Applications During Peripheral Intravenous Catheterization Placement in the Emergency Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06378424
• Other study ID #: 2023-6/6
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: August 23, 2023

Study information

• Verified date: April 2024
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 23, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diarrhea
• Emergencies
• Nausea
• Pain Management
• Vomiting

Intervention

Other:
• Cold Application
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 Application
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 Application
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.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University Hospital	Bursa	Nilüfer

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	weight	weight in kilograms	6 months
Secondary	height	height in meters	6 months