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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05422287
Other study ID # 2021/76
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 12, 2021
Est. completion date February 6, 2022

Study information

Verified date June 2022
Source Ankara Yildirim Beyazit University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date February 6, 2022
Est. primary completion date April 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Virtual Reality Glasses
Group 1
Thermomechanical Stimulation Device
Group 2

Locations

Country Name City State
Turkey Ankara Yildirim Beyazit University, Faculty of Health Sciences, Department of Nursing Ankara Cubuk

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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