Clinical trial NCT05645445: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Shockwave Lithotripsy
Pain
Anxiety
Virtual Reality
Nursing
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: pain levels
timeFrame: one day
measure: anxiety
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duzce University
name: meral Yıldırım Çetinkaya, PhD
role: PRINCIPAL_INVESTIGATOR
References: