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The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial

Primary Purpose

Shockwave Lithotripsy, Pain, Anxiety

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtual reality
Sponsored by
Duzce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shockwave Lithotripsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Applying to the stone crushing unit for the first time Body mass index below 30 Those aged 18-65 who are literate and have no vision or hearing problems Have not taken any analgesics other than the analgesic routinely administered before the procedure Exclusion Criteria: Untreated urinary tract infections Severe skeletal system malformations that prevent focusing on the stone Severe obesity Arterial aneurysm near the stone Patients with anatomical obstruction conditions in the distal part of the stone

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    control group

    virtual reality group

    Arm Description

    The routine ESWL procedure will be applied. Pre-procedural anxieties will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Scale. After the ESWL procedure, their anxiety will be re-evaluated with the same scale, and their pain will also be evaluated with the Visual Analog Scale.

    The pre-procedure anxiety of the patients who will use virtual reality glasses during the ESWL process will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Score. After the ESWL procedure, their anxiety will be re-evaluated with the same scale and in addition to the pain, the pain will be evaluated with the Visual Analog Scale.

    Outcomes

    Primary Outcome Measures

    pain levels
    pain measurement will be made by visual analog scale (VAS). The intensity will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt my life). The pain level will be asked one times before the shockwave process.
    anxiety
    Anxiety levels will be measure by the State-Trait Anxiety Inventory-State Anxiety (STAI-SA). The STAI scores were calculated based on the patients' answers. The overall score ranges from 20-80 and the higher the score indicates the higher the anxiety level. Patients with the STAI scores of 35 or lower were considered as having 'no anxiety' while patients with scores of 42 or higher were considered as 'severely anxious' as recommended by the practice guidelines. The survey will be used before and after shockwave for measure the anxiety levels in two groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2022
    Last Updated
    December 2, 2022
    Sponsor
    Duzce University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05645445
    Brief Title
    The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial
    Official Title
    The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 15, 2022 (Anticipated)
    Primary Completion Date
    June 15, 2023 (Anticipated)
    Study Completion Date
    April 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duzce University

    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
    This research was planned as a randomized controlled experimental study in order to evaluate the effect of virtual reality application on pain and anxiety caused by the procedure during stone crushing process (ESWL) with shock waves.
    Detailed Description
    Although urinary tract stones often remain asymptomatic at first, they can cause pain, hematuria, infection, decreased kidney function and kidney failure over time and can seriously affect the quality of life of people if not treated with appropriate methods. Extracorporeal shockwave lithotripsy (ESWL) has been practiced as a treatment method to remove urolithiasis from the kidneys and ureters since the early 1980s. The process is based on the principle that the sound waves obtained from a source other than the body are turned into shock waves and sent to the stone and the stone is broken down. Relief of pain and anxiety during ESWL; In addition to maintaining patient comfort and satisfaction, it is extremely important to reduce the movement of the patient during the procedure and to facilitate the imaging and targeting of the stone. Diverting attention is one of the most preferred methods to reduce the pain that occurs in patients while the diagnosis and treatment procedures are carried out. This method; It is a method that focuses the attention of patients on a different point and keeps the symptoms they experience under control and reduces them. Strategies to divert attention include the application of virtual reality, which has been one of the methods that have attracted attention in recent years. The individual focuses his attention on the image by moving away from real life with the glasses connected to the device worn on his head and the sounds coming from the headphones and feels as if he is in a different world thanks to these glasses. In practice, it is aimed to reduce the patient's pain, discomfort and anxiety by drawing the patient's attention from pain and painful treatment procedures to a fun virtual environment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shockwave Lithotripsy, Pain, Anxiety, Virtual Reality, Nursing

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The routine ESWL procedure will be applied. Pre-procedural anxieties will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Scale. After the ESWL procedure, their anxiety will be re-evaluated with the same scale, and their pain will also be evaluated with the Visual Analog Scale.
    Arm Title
    virtual reality group
    Arm Type
    Experimental
    Arm Description
    The pre-procedure anxiety of the patients who will use virtual reality glasses during the ESWL process will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Score. After the ESWL procedure, their anxiety will be re-evaluated with the same scale and in addition to the pain, the pain will be evaluated with the Visual Analog Scale.
    Intervention Type
    Device
    Intervention Name(s)
    virtual reality
    Intervention Description
    patients who include intervention gruop during the ESWL process, patients will be shown videos with virtual reality glasses, which include nature and landscapes, giving people a feeling of comfort and peace, and making them feel like they are inside.
    Primary Outcome Measure Information:
    Title
    pain levels
    Description
    pain measurement will be made by visual analog scale (VAS). The intensity will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt my life). The pain level will be asked one times before the shockwave process.
    Time Frame
    one day
    Title
    anxiety
    Description
    Anxiety levels will be measure by the State-Trait Anxiety Inventory-State Anxiety (STAI-SA). The STAI scores were calculated based on the patients' answers. The overall score ranges from 20-80 and the higher the score indicates the higher the anxiety level. Patients with the STAI scores of 35 or lower were considered as having 'no anxiety' while patients with scores of 42 or higher were considered as 'severely anxious' as recommended by the practice guidelines. The survey will be used before and after shockwave for measure the anxiety levels in two groups.
    Time Frame
    one day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Applying to the stone crushing unit for the first time Body mass index below 30 Those aged 18-65 who are literate and have no vision or hearing problems Have not taken any analgesics other than the analgesic routinely administered before the procedure Exclusion Criteria: Untreated urinary tract infections Severe skeletal system malformations that prevent focusing on the stone Severe obesity Arterial aneurysm near the stone Patients with anatomical obstruction conditions in the distal part of the stone
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zülal Kütük
    Phone
    +905377737389
    Email
    zulalkutuk81@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    meral Yıldırım Çetinkaya, PhD
    Phone
    +905366295020
    Email
    meralyildirim@duzce.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    meral Yıldırım Çetinkaya, PhD
    Organizational Affiliation
    Duzce University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial

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