Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

NCT06079814 | Recruiting

• 1 other identifier: 5312256929
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain; Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

experiment group

EXPERIMENTAL

Patients will wear virtual reality glasses 10 minutes before cystoscopy. The content chosen by the patient (there will be three options) will be watched throughout the procedure.

Other: virtual reality intervention

control group

NO INTERVENTION

Standard procedure.

Interventions

virtual reality intervention OTHER

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

experiment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, 01030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic Nurse

Study Record Dates

• First Submitted: October 2, 2023
• First Posted: October 12, 2023
• Study Start: October 10, 2023
• Primary Completion: September 10, 2024
• Study Completion: December 10, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

TU (1)