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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05645445
• Other study ID #: Meral3
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2022
• Source: Duzce University
• Contact: Zülal Kütük
• Phone: +905377737389
• Email: zulalkutuk81[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: April 15, 2024
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Nursing
• Pain
• Virtual Reality

Intervention

Device:
• virtual reality
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Primary	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.	one day