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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
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    April 20, 2023
    Last Updated
    July 19, 2023
    Sponsor
    Akdeniz University
    Collaborators
    TUBİTAK
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    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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