Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

Sponsor

Cukurova University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06079814

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Anxiety	Other: virtual reality intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 10, 2023

Anticipated Primary Completion Date :

Jan 10, 2024

Anticipated Study Completion Date :

Mar 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experiment group 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 Patients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure.
No Intervention: control group Standard procedure.

Arm

Intervention/Treatment

Experimental: experiment group

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

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

No Intervention: control group

Standard procedure.

Outcome Measures

Primary Outcome Measures

The effect of virtual reality applications on pain during cystoscopy [30 minutes after the procedure]
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.
The effect of virtual reality applications on anxiety during cystoscopy [30 minutes after the procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cukurova University	Adana		Turkey	01030

Sponsors and Collaborators

Cukurova University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seyma Yurtseven, Dr., Cukurova University

ClinicalTrials.gov Identifier:

NCT06079814

Other Study ID Numbers:

5312256929

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 12, 2023