NCT07893262

Brief Summary

Brief Summary / Aim This study aimed to determine the effect of showing videos using virtual reality goggles (VRG), in addition to routine care and follow-up, on pain, anxiety levels, and patient satisfaction during transurethral bladder catheterization (TBC). Materials and Methods This pre-test-post-test randomized controlled experimental study included patients undergoing transurethral bladder catheterization for the first time. A total of 91 participants were enrolled and randomly assigned to an intervention group (n=46) and a control group (n=45). Data were collected using the Patient Information Form (PIF), Visual Analog Scale (VAS), Beck Anxiety Scale (BAS), and Patient Satisfaction Assessment Questionnaire (PSAQ). Participants in the intervention group were shown videos using virtual reality goggles in addition to routine care during the transurethral bladder catheterization procedure. Participants in the control group received routine care. Pain, anxiety, and patient satisfaction were assessed according to the study protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

5 months

First QC Date

October 5, 2026

Last Update Submit

October 21, 2026

Conditions

Keywords

AnxietyNursing CarePainPatient SatisfactionVirtual RealityUrinary catheterization

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scores

    Pain intensity will be assessed using the Visual Analog Scale (VAS) before and after the transurethral bladder catheterization procedure.

    5 minutes after urinary catheterization

  • Beck Anxiety Scale

    Anxiety: Anxiety levels will be assessed using the Beck Anxiety Scale (BAS) before and after the transurethral bladder catheterization procedure.

    5 minutes after urinary catheterization

  • Patient Satisfaction Assessment Questions

    \*\*Patient Satisfaction:\*\* Patient satisfaction with the transurethral bladder catheterization procedure will be assessed using the Patient Satisfaction Assessment Questionnaire (PSAQ) following the procedure. Satisfaction with the virtual reality headset application will also be assessed among participants in the intervention group.

    5 minutes after urinary catheterization

Study Arms (2)

Virtual reality glasses group

EXPERIMENTAL

In addition to routine care, participants in this group were shown videos using virtual reality goggles during urinary catheterization.

Other: Virtual reality glasses

Control group

NO INTERVENTION

No additional interventions, other than routine care, were performed on the participants in this group.

Interventions

In addition to routine care, participants in the intervention group were shown videos using virtual reality headsets during catheterization.

Virtual reality glasses group

Eligibility Criteria

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

You may qualify if:

  • Female patients
  • Patients undergoing TBC for the first time
  • french foley catheter inserted
  • Patients receiving inpatient or outpatient care in the urology department
  • Patients with at least a basic literacy level
  • Patients who do not wear prescribed glasses that would interfere with VRG placement
  • Patients without migraine, vertigo, active nausea, vomiting, or headache
  • Patients without a diagnosed psychiatric disorder
  • Patients who volunteered to participate in the study
  • Patients without mental disability or communication barriers were included in the study.

You may not qualify if:

  • Those with severe vision problems
  • Those who were not willing to participate in the study
  • Those who had previously undergone TBC
  • Those with a history of urological or gynecological surgery
  • Those experiencing pain before the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tekirdag Namık Kemal University

Tekirdağ, süleymanpaşa, 59100, Turkey (Türkiye)

Location

Related Publications (3)

  • Cao, L., Qi, X., Liu, D., Mao, X., Luo, L., Liu, M., Wen, X., Cui, C., Qi, J., Xu, J., & Cui, Y. (2024). Effect of continuous infusion in alleviating pain during male urethral catheterization. BMC Anesthesiology, 24, 457. https://doi.org/10.1186/s12871-024-02848-4 Moreau, S., Thérond, A., Cerda, I. H., Studer, K., Pan, A., Tharpe, J., Crowther, J. E., Abd-Elsayed, A., Gilligan, C., Tolba, R., Ashina, S., Schatman, M. E., Kaye, A. D., Yong, R. J., & Robinson, C. L. (2024). Virtual reality in acute and chronic pain medicine: An updated review. Current Pain and Headache Reports, 28, 893-928. https://doi.org/10.1007/s11916-024-01246-2

    BACKGROUND
  • Chen H, Li X, Cui H, Xiao X, Zhang Q, Gao X. Development of a knowledge, attitude and practice questionnaire on urine leakage with an indwelling urethral catheter for nurses in China. Nurs Open. 2023 May;10(5):2960-2970. doi: 10.1002/nop2.1539. Epub 2022 Dec 11.

    PMID: 36503181BACKGROUND
  • Haider, M. Z., & Annamaraju, P. (2023, August 8). Bladder catheterization. In StatPearls [Internet]. Treasure Island, FL: StatPearls Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK560748/

    BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPainPatient Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

October 5, 2026

First Posted

October 23, 2026

Study Start

April 1, 2026

Primary Completion

August 31, 2026

Study Completion

August 31, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations