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

NCT ID: NCT05422287

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2022-02-06

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.

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.

Conditions

Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Virtual Reality Glasses

Intervention Type: OTHER

Group 1

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.

Group Type: EXPERIMENTAL

Thermomechanical Stimulation Device

Intervention Type: OTHER

Group 2

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Virtual Reality Glasses

Group 1

Intervention Type: OTHER

Thermomechanical Stimulation Device

Group 2

Intervention Type: OTHER

Other Intervention Names

VRG; Buzzy

Eligibility Criteria

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

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

Sponsors

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Erek Kazan

Assist.Prof.Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Züleyha Setenay Serin, MsN

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Ankara, Cubuk, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 40418199 (View on PubMed)

Other Identifiers

2021/76

Identifier Type: -

Identifier Source: org_study_id