Effect of Virtual Glasses on Pain and Comfort During ESWL
Primary Purpose
Extracorporeal Shock Wave Lithotripsy, Lithotripsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ESWL Group
Sponsored by
About this trial
This is an interventional prevention trial for Extracorporeal Shock Wave Lithotripsy focused on measuring ESWL, Pain, comfort level, virtual glasses
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ESWL Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05842668
First Posted
April 20, 2023
Last Updated
July 19, 2023
Sponsor
Akdeniz University
Collaborators
TUBİTAK
1. Study Identification
Unique Protocol Identification Number
NCT05842668
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
March 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
Collaborators
TUBİTAK
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extracorporeal Shock Wave Lithotripsy, Lithotripsy
Keywords
ESWL, Pain, comfort level, virtual glasses
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ESWL Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
ESWL Group
Intervention Description
Increasing comfort and reducing pain during ESWL
Primary Outcome Measure Information:
Title
Comfort Score
Description
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.
Time Frame
5-10 minutes before ESWL
Title
Pain Score (Visual analog Score)
Description
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.
Time Frame
5-10 minutes before ESWL
Secondary Outcome Measure Information:
Title
Comfort Score
Description
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.
Time Frame
15 minutes after ESWL
Title
Pain Score (Visual analog Score)
Description
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.
Time Frame
15 minutes after ESWL
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatma Zehra Çobanoğlu
Phone
+905377799269
Email
fatmazehracobanoglu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Virtual Glasses on Pain and Comfort During ESWL
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