Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616324
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality an Innovative Approach to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy - a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 scoresvalues
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
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 scoresvalues
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
Detailed Description:
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 Shockwave 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
Furthermore the study aims to gather data on patients perspectives regarding the functionality and efficacy of VR technology in enhancing their intraprocedural experience This includes an evaluation of VRs role in contribution to the overall procedural experience
Introduction According to the European Association of Urology EAU guidelines urolithiasis is treated with ESWL Ureteroscopy URS Percutaneous Nephrolithotomy PNL or other surgical treatments that may relieve the obstructive symptoms of the urinary tract EAU recommends ESWL as the primary treatment for renal pelvic and proximal ureteral stones of 20 mm The success of ESWL is closely related to factors such as the experience of the urologist using the machine localization of the stone urinary system anatomy and the patients compliance with the procedure To ensure compliance it is important to minimize patients pain and anxiety To handle pain and anxiety various ways including both pharmacological and non-pharmacological approaches are in use today Pharmacological control of pain and anxiety including the use of sedation is a complex decision that consider both benefits and potential risks While not highly recommended due to the side effects associated with these agents such as hypotension respiratory depression confusion and limitations in ability to operate machines sedation medication can be an effective means of managing pain and anxiety when used judiciously
Non-pharmacological alternatives have been recommended for decreasing pain and anxiety during ESWL as for example music which have been found beneficial in several studies VR can immerse patients into a virtual environment and distract patients from eg unpleasant sounds sights and feelings Integrating VR into hospital settings has shown the potential to offer several advantages such as promoting patients distraction knowledge and information The advantage lies in the engagement of multiple sensory perceptions including hearing and vision which can be beneficial in enhancing the potential for reduced experiences of pain and anxiety as these perceptions typically strengthen humans cognitive memory The hypothesis is that distraction from VR can lower pain perception and reduce anxiety for patient undergoing EWSL compared with standard care
Virtual Reality VR has been widely used in psychiatry and for children when they need to have a peripheral venous catheter inserted Many studies show that VR has a distracting effect and this distraction can be used to reduce both pain and anxiety The novelty of this research study lies in using VR during ESWL so that the patient experiences less pain and anxiety There is only one study from 2023 conducted in Belgium which investigates whether VR is effective in reducing pain in kidney stone patients during ESWL This study is a randomized controlled trial RCT and its results support the use of VR as a method for pain relief during ESWL
There is a significant need for more evidence-based research studies in this area With more research it will be possible to better assess whether VR has the desired effect and relevance within medical procedures
Method The trial will be designed as a randomized controlled clinical trial while being adequately powered for the primary outcome The randomization will be computer-generated randomization by the statistic programme R studio with sequence 11 by a colleague not associated to the study The sample size estimation showed that 72 participants are needed with a 15 drop rate The participants will be randomized into one of two groups There will be randomization on the day of inclusion by REDcap which also store the data about the patients
Because of VRs nature it is impossible to blind the participants The outcome assessors investigators data analysts and manuscript writers will be blinded The participants are patients undergoing urological procedure at Zealand University Hospital Roskilde All ASA scores are accepted
All patients scheduled for ESWL will be screened based on the inclusion and exclusion criteria Patients are eligible if they meet all inclusion criteria and none of the exclusion criteria Intervention Group Patients will receive ESWL using the EDAP-TMS model Sonolith i-sys machine with standard medication supplemented by a Virtual Reality headset and Active-Noise-Cancelling ANC headphones which will play a video of the patients choice Control Group Patients will receive ESWL with standard medication without the addition of VR or ANC-headphones Participation in this trial will not result in prolonged admission or require additional follow-up visits
The four different videos of what the patient can choose from are developed specific for intraprocedural use and have been established in cooperation with people older than 65 years of age private company Khora and Zealand University Hospital Denmark and Lund University The videos are created to fit different personalities and needs when persons undergo painful procedures The development of the videos has focused on comprehending videos that have movement colours sound and pixels quality to prevent cyber sickness
Standard intraprocedural management All patients will follow the traditional standard treatment which includes Paracetamol and Ibuprofen as premedication with the possibility of receiving sublingual fentanyl during procedure to comfort the patient
Furthermore the study aims to gather data on patients perspectives regarding the functionality and efficacy of VR technology in enhancing their intraprocedural experience This includes an evaluation of VRs role in contribution to the overall procedural experience
Introduction According to the European Association of Urology EAU guidelines urolithiasis is treated with ESWL Ureteroscopy URS Percutaneous Nephrolithotomy PNL or other surgical treatments that may relieve the obstructive symptoms of the urinary tract EAU recommends ESWL as the primary treatment for renal pelvic and proximal ureteral stones of 20 mm The success of ESWL is closely related to factors such as the experience of the urologist using the machine localization of the stone urinary system anatomy and the patients compliance with the procedure To ensure compliance it is important to minimize patients pain and anxiety To handle pain and anxiety various ways including both pharmacological and non-pharmacological approaches are in use today Pharmacological control of pain and anxiety including the use of sedation is a complex decision that consider both benefits and potential risks While not highly recommended due to the side effects associated with these agents such as hypotension respiratory depression confusion and limitations in ability to operate machines sedation medication can be an effective means of managing pain and anxiety when used judiciously
Non-pharmacological alternatives have been recommended for decreasing pain and anxiety during ESWL as for example music which have been found beneficial in several studies VR can immerse patients into a virtual environment and distract patients from eg unpleasant sounds sights and feelings Integrating VR into hospital settings has shown the potential to offer several advantages such as promoting patients distraction knowledge and information The advantage lies in the engagement of multiple sensory perceptions including hearing and vision which can be beneficial in enhancing the potential for reduced experiences of pain and anxiety as these perceptions typically strengthen humans cognitive memory The hypothesis is that distraction from VR can lower pain perception and reduce anxiety for patient undergoing EWSL compared with standard care
Virtual Reality VR has been widely used in psychiatry and for children when they need to have a peripheral venous catheter inserted Many studies show that VR has a distracting effect and this distraction can be used to reduce both pain and anxiety The novelty of this research study lies in using VR during ESWL so that the patient experiences less pain and anxiety There is only one study from 2023 conducted in Belgium which investigates whether VR is effective in reducing pain in kidney stone patients during ESWL This study is a randomized controlled trial RCT and its results support the use of VR as a method for pain relief during ESWL
There is a significant need for more evidence-based research studies in this area With more research it will be possible to better assess whether VR has the desired effect and relevance within medical procedures
Method The trial will be designed as a randomized controlled clinical trial while being adequately powered for the primary outcome The randomization will be computer-generated randomization by the statistic programme R studio with sequence 11 by a colleague not associated to the study The sample size estimation showed that 72 participants are needed with a 15 drop rate The participants will be randomized into one of two groups There will be randomization on the day of inclusion by REDcap which also store the data about the patients
Because of VRs nature it is impossible to blind the participants The outcome assessors investigators data analysts and manuscript writers will be blinded The participants are patients undergoing urological procedure at Zealand University Hospital Roskilde All ASA scores are accepted
All patients scheduled for ESWL will be screened based on the inclusion and exclusion criteria Patients are eligible if they meet all inclusion criteria and none of the exclusion criteria Intervention Group Patients will receive ESWL using the EDAP-TMS model Sonolith i-sys machine with standard medication supplemented by a Virtual Reality headset and Active-Noise-Cancelling ANC headphones which will play a video of the patients choice Control Group Patients will receive ESWL with standard medication without the addition of VR or ANC-headphones Participation in this trial will not result in prolonged admission or require additional follow-up visits
The four different videos of what the patient can choose from are developed specific for intraprocedural use and have been established in cooperation with people older than 65 years of age private company Khora and Zealand University Hospital Denmark and Lund University The videos are created to fit different personalities and needs when persons undergo painful procedures The development of the videos has focused on comprehending videos that have movement colours sound and pixels quality to prevent cyber sickness
Standard intraprocedural management All patients will follow the traditional standard treatment which includes Paracetamol and Ibuprofen as premedication with the possibility of receiving sublingual fentanyl during procedure to comfort the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None