Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital
About this trial
The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements.
The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group.
The secondary outcomes are as follows:
* Type and dose of analgesia * Conductance scores/values * Anxiety levels * Patient satisfaction * Procedure duration * Adverse events
Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for ESWL at Region Zealand
Age of 18 or above
Ability to understand the trial protocol, risks, and benefits and provide signed informed consent
Disqualifiers
Inability to read and understand Danish.
Uncooperativeness (as judged by investigators)
Claustrophobia or fear of small spaces
Disorders that prevent the person from wearing a VR device
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual Reality
DeviceParticipants in the intervention group will undergo ESWL according to standard treatment but with the addition of Virtual Reality and ANC-headphones as a supplement.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: InterventionExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain at energy level 900
Data about the pain is registered at energy level 900 during the ESWL treatment for the intervention and the control group. The pain is measured by using the Numeric Rating Scale rating from 0-10. Zero is no pain at all and 10 is the worst imaginable pain. The outcome measure will be assessed during the patient ESWL treatment when the energy level of 900 is reached.
Time frame
The outcome measure will be assessed from the start of the patient's ESWL treatment until the end of the procedure, with an average treatment duration of approximately 45 minutes.Secondary outcomes
1
Patient Satisfaction
Patient satisfaction will be measured using a Likert scale from 1 to 5, where 1 and 2 indicate dissatisfaction, 3 is neutral, and 4 or 5 indicate satisfaction.
Time frame
The outcome measure will be assessed by the patient 1 hour or less after the ESWL treatment have ended.2
Adverse events
Adverse events are defined as any unwanted event, sign, or symptom occurring during the trial, whether the adverse is related to the VR head-mounted display or not. If any adverse events occur they will be noted.
Time frame
The outcome measure will be noted during or less than 1 hour after the ESWL treatment is finished.3
Procedure duration
The procedure time will be recorded and is defined as the duration from the first shock wave to the last.
Time frame
Measurements will be recorded for each individual during the treatment approximately 45 minutes.4
Pre- and intraprocedural pain
Pain will be measured using the Numeric Rating Scale, rating from 0 to 10, where 0 represents no pain at all and 10 represents the worst imaginable pain. A lower score is favorable.
Time frame
Measurements will be taken at the day for treatment for each individual. At arrival at preperations room and during the patients ESWL treatment approximately 2 hours time frame..Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov