Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

Pain Clinical Trial

Official title:

Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079814
• Other study ID #: 5312256929
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: December 10, 2024

Study information

• Verified date: February 2024
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 10, 2024
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Being literate,
• Being conscious,
• Ability to understand and speak Turkish and not have hearing or visual impairment,
• Agreeing to participate in the research.

Exclusion Criteria:

• Having a diagnosed psychiatric and mental illness,
• Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
• Patients who do not want to continue the study

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

Other:
• virtual reality intervention
Patients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of virtual reality applications on pain during cystoscopy	The patient's pain will be assessed using the 'Visual Analog Scale (VAS).' This scale involves marking on a 10 cm vertical or horizontal line, with one end indicating no pain at all and the other end indicating the most severe pain, to assess and measure the level of pain.	30 minutes after the procedure
Primary	The effect of virtual reality applications on anxiety during cystoscopy	Procedure related anxiety will be assessed using the 'State Anxiety Inventory.' This inventory consists of a total of 20 items and the scoring ranges from 20 to 80 points. The higher the total score obtained from the scale, the higher the level of anxiety experienced by the individual is interpreted.	30 minutes after the procedure