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Clinical Trials/NCT05645445
NCT05645445Not yet recruitingNot Applicable

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

Duzce University0 sites72 target enrollmentStarted: December 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
72
Primary Endpoint
pain levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

pain levels

Time Frame: one day

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

Time Frame: one day

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Duzce University
Sponsor Class
Other
Responsible Party
Sponsor

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