NCT06629727

Brief Summary

To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.

Trial Health

55
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 Jul 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

July 25, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

7 months

First QC Date

October 2, 2024

Last Update Submit

October 4, 2024

Conditions

Keywords

extracorporeal shock wave lithotripsypainVirtual realityAnxiety

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Scale

    Pain level during the procedure

    During ESWL procedure

Study Arms (2)

VR group

EXPERIMENTAL

Use of VR glasses during the procedure

Other: VR Group

Control Group

ACTIVE COMPARATOR

Standart care group

Other: Control group

Interventions

the experimental group was shown a video through VRG during the lithotripsy procedure.

VR group

Patients received standard care during the procedure

Control Group

Eligibility Criteria

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

You may qualify if:

  • \- Performing ESWL procedure

You may not qualify if:

  • Presence of psychiatric disease
  • Vision problem
  • Hearing problem
  • Drug and alcohol addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Beykent University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Guitynavard F, Azadvari M, Gholamnejad M, et al. Decreasing discomfort during shock-wave lithotripsy using transcutaneous electrical nerve stimulation. Translational Research in Urology. 2022; 4(2): 71-76

    RESULT
  • Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.

  • Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.

Related Links

MeSH Terms

Conditions

AgnosiaPainAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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
Health Science Faculty Vice - Dean (PhD. RN.)

Study Record Dates

First Submitted

October 2, 2024

First Posted

October 8, 2024

Study Start

July 25, 2021

Primary Completion

February 10, 2022

Study Completion

November 10, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

This was a masters thesis research, and the computer used to collect data at that time was damaged. Communication could not be established with the statistician who conducted the data analysis.

Locations