Effect of Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheterization

June 14, 2022 updated by: Ebru Erek Kazan, Ankara Yildirim Beyazıt University

The Effect of Using a Thermomechanical Stimulation Device and Virtual Reality Glasses During Peripheral Intravenous Catheter Administration on Pain and Patient Satisfaction in Adult Patients

The study was conducted as a randomized controlled experimental study to determine the effect of Thermomechanical Stimulation Device (Buzzy®) and Virtual Reality Goggles (VRG) applied during peripheral intravenous catheterization (PIC) on pain and patient satisfaction in adult patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research was carried out at the Emergency Department of the Etimesgut Şehit Sait Ertürk State Hospital in Ankara from April 2021 to February 2022. The sample of the study consisted of 126 adult patients. The patients were divided into three groups by randomization method. VRG was applied to the first group, Buzzy to the second group and the control group which was the third group using the standard procedure. Before the procedure of PIC, "Introductory Characteristics Form for Patients" was prepared by the researcher containing the sociodemographic characteristics of the participants (gender, marital status, age, educational status, etc. as such). This form was filled out by asking the patient by face-to-face interview method. After catheterization, the "Visual Comparison Scale for Pain" was used by the nurse practitioner to determine the pain of the patients and the "Visual Comparison Scale for Satisfaction" was used to determine the satisfaction status of the patients regarding the application to be performed. It is expected that pain and patient satisfaction scores in groups where a VRG and Buzzy® were used during PIC in adult patients will result more positively than in the control group. It is thought that the results obtained from the research will contribute to the literature.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cubuk
      • Ankara, Cubuk, Turkey, 06010
        • Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shold be a volunteer to participate in the research
  • Should be in the age of between 18-65 years old
  • Should not use drugs that will have an analgesic effect in the last 24 hours before admission
  • Should have successful of the first intravenous catheterization attempt
  • Absence of any psychiatric illness
  • Absence of any oncology and hematology disease
  • Should have the ability to read and write in Turkish,
  • Absence of vision, hearing and perception problems
  • Should not have a febrile illness at the time of applications
  • Should not have thin and damaged vascular structure
  • Absence of a history of fainting during blood removal
  • Should be conscious, fully oriented and cooperative, and open to communication

Exclusion Criteria:

  • Failure of the first attempt to administer intravenous catheterization
  • The unwillingness of the patient to continue the research
  • Removing the virtual reality glasses before and during the procedure
  • Discontinuing of Buzzy ® before and during the procedure
  • Deterioration of the patient's health status during the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality Glasses (VRG) Group
The participants in this group were started to watch videos by wearing virtual reality glasses about 2 minutes before the catheterization process was started and the process was continued until the end. Then, catheterization was performed by detecting the tourniquet by the emergency department nurse. Upon completion of the catheterization procedure, VRG was removed from the procedure area by the researcher. This process took an average of 5 minutes. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.
Other: Virtual Reality Glasses
Group 1
Other Names:
  • VRG
Experimental: Thermomechanical Stimulation Device (Buzzy ®) Group
1 minute before starting the catheterization procedure in this group, a cold and vibration application was placed in the operation area by the researcher using the apparatus of the Buzzy ® device and started. The procedure was performed after evaluating the vein and determining the appropriate right or left arm. At the end of this time, the Buzzy ® has been shifted approximately 5 cm above the processing zone. Then, catheterization was performed. Upon completion of the catheterization procedure, Buzzy ® was removed from the procedure area by the researcher. This process took an average of 4 minutes. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.
Other: Thermomechanical Stimulation Device
Group 2
Other Names:
  • Buzzy
No Intervention: Control group
Peripheral intravenous catheterization was performed by the same emergency department nurse in accordance with the procedure. The process took an average of 3 minutes. There was no application to the patients in the control group except for the standard procedure. After the procedure was completed, the pain and satisfaction status of the patients were scored on the VAS by the same nurse.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain of the patient during the peripheral intravenous catheterization
Time Frame: 6 month
In the study, Visual Analog Scale (VAS) was used to evaluate the pain of the patients. There is a 10 cm ruler on this scale. Patients were asked to rate the pain felt during the procedure on a 10 cm ruler. This scoring was done with a number between 1 and 10. The patient gave a score of "0" if he does not feel pain and "10" if he feels unbearable pain. After the completion of the procedure, the patients were asked to rate the pain they felt during catheterization on a visual comparison scale. At the end of the research, the scale results will be compared and evaluated for all three groups.
6 month
Satisfaction of the patients about intervention during the peripheral intravenous catheterization
Time Frame: 6 month
In the study, another visual comparison scale was used to determine the satisfaction levels of the patients regarding the application to be made. After the completion of the procedure, the patients were asked to rate their satisfaction with the procedure on the Visual Analog Scale (VAS). The scale was scored between 1 and 10, "0" was evaluated as ''I am not satisfied at all'', "10" was evaluated as ''I am very satisfied''. At the end of the research, the scale results will be compared and evaluated in three groups.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Züleyha Setenay Serin, MsN, Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021/76

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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