Back to resultsVirtual Reality Application for Pain and Anxiety Reduction During Cystoscopy
Primary Purpose
Pain, Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
virtual reality intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Pain
Eligibility Criteria
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
Sites / Locations
- Cukurova University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experiment group
control group
Arm Description
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.
Standard procedure.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06079814
Brief Title
Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy
Official Title
Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2023 (Anticipated)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
March 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experiment group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Standard procedure.
Intervention Type
Other
Intervention Name(s)
virtual reality intervention
Intervention Description
Patients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure.
Primary Outcome Measure Information:
Title
The effect of virtual reality applications on pain during cystoscopy
Description
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.
Time Frame
30 minutes after the procedure
Title
The effect of virtual reality applications on anxiety during cystoscopy
Description
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.
Time Frame
30 minutes after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01030
Country
Turkey
12. IPD Sharing Statement
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Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy
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