NCT07017660

Brief Summary

This randomized controlled experimental study aimed to determine the effect of virtual reality glasses during cystoscopy on pain, anxiety and patient satisfaction.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

June 11, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 4, 2025

Last Update Submit

June 11, 2025

Conditions

Keywords

CystoscopyPainanxietysatisfactionvirtual reality

Outcome Measures

Primary Outcomes (3)

  • Visual Analog scale

    Rating is done on a scale with a 10 cm horizontal or vertical ruler and "0" means dissatisfaction and "10" means the highest level of satisfaction.

    1 day

  • Visual Analog Scale

    Grading is made with a 10 cm long horizantal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain.

    1 day

  • Spielberg State Anxiety Scale

    The scale has a four-point Likert structure consisting of 20 items, and a total score of 20-80 is obtained.

    1 day

Study Arms (2)

control group

OTHER

Routine institution procedures will be applied during the cystoscopy procedure.

Other: No intervention

virtual reality glasses

EXPERIMENTAL

Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until the procedure is completed. The patient will be shown a video of nature scenes with the virtual reality glasses and will also be made to listen to the sounds of water and birds. Routine institution procedures will be applied during the cystoscopy procedure.

Other: virtual reality glasses

Interventions

Patients will be asked to wear virtual reality glasses starting three minutes before the procedure and until it is completed. With the virtual reality glasses, the patient will be shown a video of nature scenes and made to listen to the sounds of water and birds. Routine institutional procedures will be applied during the cystoscopy procedure.

virtual reality glasses

Routine institution procedures will be applied during the cystoscopy procedure.

control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older,
  • First elective and rigid cystoscopy performed under local anesthesia,
  • No vision, hearing and perception problems,
  • Open to communication and able to speak Turkish,
  • Patients who agree to participate in the study

You may not qualify if:

  • Contraindications for the procedure (lidocaine allergy, urinary tract infection, anatomical problems related to the urethra, etc.)
  • Use of any analgesic or sedative medication at least 4 hours before cystoscopy Patients who undergo manipulation such as J stent placement or removal and/or bladder biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

PainAnxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior

Study Officials

  • Ayten Akkaya, PhD

    Ankara Medipol University Faculty of Health Sciences, Department of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayten Akkaya, PhD

CONTACT

Hasan N. G. Göktuğ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

June 11, 2025

Primary Completion

August 1, 2025

Study Completion

October 1, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations