NCT06378424

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2024

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

April 18, 2024

Last Update Submit

April 18, 2024

Conditions

Keywords

Hot applicationcold applicationperipheral intravenous catheterizationvenous dilationpainvibration

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

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.

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.

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.

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.

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.

Cold 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.

Heat Application Group

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.

Vibration Application Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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.

MeSH Terms

Conditions

AgnosiaEmergenciesDiarrheaNauseaVomitingPain

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesSigns and Symptoms, Digestive

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

Locations