The Effect of Virtual Reality Application on Pain and Anxiety Level in Stone Crushing With Shock Waves: A Randomized Controlled Trial
1 other identifier
interventional
72
0 countries
N/A
Brief Summary
This research was planned as a randomized controlled experimental study in order to evaluate the effect of virtual reality application on pain and anxiety caused by the procedure during stone crushing process (ESWL) with shock waves.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2022
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
December 2, 2022
CompletedFirst Posted
Study publicly available on registry
December 9, 2022
CompletedStudy Start
First participant enrolled
December 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedDecember 9, 2022
December 1, 2022
6 months
December 2, 2022
December 2, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
pain levels
pain measurement will be made by visual analog scale (VAS). The intensity will measure the area in which the individual mark between 0 (no pain) and 10 (worst pain i felt my life). The pain level will be asked one times before the shockwave process.
one day
anxiety
Anxiety levels will be measure by the State-Trait Anxiety Inventory-State Anxiety (STAI-SA). The STAI scores were calculated based on the patients' answers. The overall score ranges from 20-80 and the higher the score indicates the higher the anxiety level. Patients with the STAI scores of 35 or lower were considered as having 'no anxiety' while patients with scores of 42 or higher were considered as 'severely anxious' as recommended by the practice guidelines. The survey will be used before and after shockwave for measure the anxiety levels in two groups.
one day
Study Arms (2)
control group
NO INTERVENTIONThe routine ESWL procedure will be applied. Pre-procedural anxieties will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Scale. After the ESWL procedure, their anxiety will be re-evaluated with the same scale, and their pain will also be evaluated with the Visual Analog Scale.
virtual reality group
EXPERIMENTALThe pre-procedure anxiety of the patients who will use virtual reality glasses during the ESWL process will be evaluated with the State-Trait Anxiety Inventory-State Anxiety Score. After the ESWL procedure, their anxiety will be re-evaluated with the same scale and in addition to the pain, the pain will be evaluated with the Visual Analog Scale.
Interventions
patients who include intervention gruop during the ESWL process, patients will be shown videos with virtual reality glasses, which include nature and landscapes, giving people a feeling of comfort and peace, and making them feel like they are inside.
Eligibility Criteria
You may qualify if:
- Applying to the stone crushing unit for the first time
- Body mass index below 30
- Those aged 18-65 who are literate and have no vision or hearing problems
- Have not taken any analgesics other than the analgesic routinely administered before the procedure
You may not qualify if:
- Untreated urinary tract infections
- Severe skeletal system malformations that prevent focusing on the stone
- Severe obesity
- Arterial aneurysm near the stone
- Patients with anatomical obstruction conditions in the distal part of the stone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duzce Universitylead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
meral Yıldırım Çetinkaya, PhD
Duzce University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2022
First Posted
December 9, 2022
Study Start
December 15, 2022
Primary Completion
June 15, 2023
Study Completion
April 15, 2024
Last Updated
December 9, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share