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

NCT05422287 | Completed

• 1 other identifier: 2021/76
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheterization

Keywords

Nursing; pain; patient satisfaction; peripheral intravenous catheterization; thermomechanical stimulation; virtual reality

Outcome Measures

Primary Outcomes (2)

• Pain of the patient during the peripheral intravenous catheterization

  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

  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

Study Arms (3)

Virtual Reality Glasses (VRG) Group

EXPERIMENTAL

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

Thermomechanical Stimulation Device (Buzzy ®) Group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Virtual Reality Glasses OTHER

Group 1

Also known as: VRG

Virtual Reality Glasses (VRG) Group

Thermomechanical Stimulation Device OTHER

Group 2

Also known as: Buzzy

Thermomechanical Stimulation Device (Buzzy ®) Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

Ankara, Cubuk, 06010, Turkey (Türkiye)

Location

Related Publications (1)

• Serin ZS, Kazan EE. The Effect of Using Thermomechanical Stimulation and Virtual Reality Glasses During Peripheral Intravenous Catheterization on Pain and Patient Satisfaction: A Randomized Controlled Trial. J Emerg Nurs. 2025 Sep;51(5):925-935. doi: 10.1016/j.jen.2025.04.005. Epub 2025 May 26.

  PMID: 40418199 DERIVED

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Züleyha Setenay Serin, MsN

  Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist.Prof.Dr.

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 16, 2022
• Study Start: April 12, 2021
• Primary Completion: April 26, 2021
• Study Completion: February 6, 2022
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)