Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy

NCT06804928 | Completed

• 1 other identifier: Scansuscansu92
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL

Conditions

ESWL; Anxiety; Pain; Comfort; Virtual Reality

Outcome Measures

Primary Outcomes (7)

• VAS

  Pain levels will be assessed.

  Data will be collected 10 minutes before the procedure.

• Visual Anxiety Scale (VAS-A)

  Anxiety levels will be assessed.

  Data will be collected 10 minutes before the procedure.

• Visual Comfort Scale

  Comfort levels will be assessed.

  Data will be collected 10 minutes before the procedure.

• Spielberger Trait Anxiety Inventory (STAI-II)

  It will be used to measure trait anxiety levels before the procedure.

  The measurement will be conducted only once, 10 minutes before the procedure.

• VAS

  Pain levels will be assessed.

  Data will be collected 30 minutes after the procedure.

• Visual Anxiety Scale (VAS-A)

  Anxiety levels will be assessed.

  Data will be collected 30 minutes after the procedure.

• Visual Comfort Scale

  Comfort levels will be assessed.

  Data will be collected 30 minutes after the procedure.

Study Arms (2)

VR-G (Virtual Reality Group) (1)

EXPERIMENTAL

During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure.

Behavioral: Virtual Reality Glasses

Control Group (2)

NO INTERVENTION

No intervention will be applied to the patients in the control group, and the standard care protocol of the clinic will be followed.

Interventions

Virtual Reality Glasses BEHAVIORAL

During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure.

Also known as: Control group

VR-G (Virtual Reality Group) (1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older, Having no hearing or perception impairments, Having no visual impairments, Undergoing ESWL for the first time.

You may not qualify if:

• Use of any analgesic or anxiolytic medication before the procedure, Having a psychiatric disorder, The procedure being performed on an emergency basis.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Samsun Gazi State Hospital

Samsun, Merkez, 55070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The measurements will be conducted by an individual independent of the study. Additionally, the statistical analysis of the research will be performed by a statistician who is unaware of the study details. The randomization plan was also prepared by a researcher independent of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 11, 2026

Record last verified: 2025-11

Locations

TU (1)