Effect of Virtual Glasses on Pain and Comfort During ESWL

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Extracorporeal Shock Wave Lithotripsy, Lithotripsy

Intervention / Treatment
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* Behavioral: ESWL Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWL Group<br> | Behavioral: ESWL Group<br>* Increasing comfort and reducing pain during ESWL<br>|
| No Intervention: Control Group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Score | The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48. | 5-10 minutes before ESWL | 
| Pain Score (Visual analog Score) | Grading is made with a 10 cm long horizontal or vertical ruler on the scale and 0 means no pain and 10 means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded. | 5-10 minutes before ESWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort Score | The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48. | 15 minutes after ESWL | 
| Pain Score (Visual analog Score) | Grading is made with a 10 cm long horizontal or vertical ruler on the scale and 0 means no pain and 10 means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded. | 15 minutes after ESWL | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESWL, Pain, comfort level, virtual glasses