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

NCT ID: NCT06378424

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2023-08-23

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.

Conditions

Pain Management; Emergency Unit; Diarrhea; Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Cold Application Group

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.

Group Type: EXPERIMENTAL

Cold Application

Intervention Type: OTHER

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 Group

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.

Group Type: EXPERIMENTAL

Heat Application

Intervention Type: OTHER

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 Group

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.

Group Type: EXPERIMENTAL

Vibration Application

Intervention Type: OTHER

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.

The control group

No intervention was performed on the control group before the peripheral intravenous catheterization procedure, and the standard peripheral intravenous catheterization procedure was performed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• 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

Exclusion Criteria

• Not participating voluntarily in the research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uludag University

OTHER

Sponsor Role: lead

Responsible Party

Dilek Yilmaz, PhD

Associate Professor, Bursa Uludag University, Department of Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bursa Uludag University Hospital

Bursa, Nilüfer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39385099 (View on PubMed)

Other Identifiers

2023-6/6

Identifier Type: -

Identifier Source: org_study_id