Clinical trial NCT05842668: Effect of Virtual Glasses on Pain and Comfort During ESWL
Official title: Investigation of the Effect of Virtual Glasses Used During Extracorporeal Shock Wave Lithotripsy-ESWL on Patient's Pain and Comfort Level: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Extracorporeal Shock Wave Lithotripsy
Lithotripsy
Keywords: ESWL
Pain
comfort level
virtual glasses
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2023-05-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL.

The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. As hypothesis tests, analysis will be made with Mann Whitney U, student t test, and chi-square tests. The findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.

Detailed description: After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo ESWL procedure and explain the purpose of the research. Informed consent will be obtained from patients who volunteered to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. Data will be collected from the first patient who will undergo the ESWL procedure. Pain with VAS and comfort level with General comfort scale will be checked 5-10 minutes before the procedure. According to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. When the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. No intervention will be performed on the patient in the control group. The first patient will go to the operation room. Patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. No intervention will be performed on the patient in the control group. All patient groups will be checked for pain with VAS and comfort level with general comfort scale 30 minutes after the end of the procedure. At the end of the procedure, the patient will come to the service. No intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* Absence of hearing and perception problems,
* Absence of any visual impairment,
* ESWL procedure will be performed for the first time,

Exclusion Criteria:

* Using any analgesic or anxiolytic before the procedure,
* Having a psychiatric disorder

Primary outcomes:
measure: Comfort Score
timeFrame: 5-10 minutes before ESWL
measure: Pain Score (Visual analog Score)
timeFrame: 5-10 minutes before ESWL
Secondary outcomes:
measure: Comfort Score
timeFrame: 15 minutes after ESWL
measure: Pain Score (Visual analog Score)
timeFrame: 15 minutes after ESWL
Other outcomes:
Locations:
Study officials:
References: