Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562829
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
The Main Content of This Study is to Use Virtual Reality Technology Combined With Local Anesthesia With Lidocaine Injection at Different Times to Reduce the Pain of PICC in School-age Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Application Effect of VR Combined With Lidocaine Local Infiltration Anesthesia in PICC Placement
Status:
COMPLETED
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:
We try to through the use of virtual reality technology in combination with lidocaine in different injection time to reduce the pain of PICC catheter school-age children Using the convenience sampling method the selection in May 2020 2021 - may need to PICC placement of children as the research object is divided into three groups A B c group A in ultrasound guided by PICC placement Group B and group C adopt VR intervention and 5 min before the beginning of the next surgery using VR equipment Group B was anesthetized after the needle was placed into the guide wire and group C was anesthetized before the needle was placed into the guide wire
Detailed Description:
This study investigated the effect of VR combined with lidocaine local infiltration anesthesia in peripherally inserted central catheter PICC insertion aiming to improve one-needle puncture success rate reduce pain reduce fear improve compliance and catheterization time
From May 2020 to May 2021 children requiring PICC were recruited by convenience sampling and divided into three groups A B and C Group A was implanted with PICC under ultrasound guidance Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began Group B was anesthetized after the puncture needle was sent into the guide wire and group C was anesthetized before the puncture needle was sent into the guide wireThe success rate of one puncture pain fear compliance and catheterization time were compared among the three groups A sample size and power analysis were conducted to determine the sample size requiredThe investigators assumed a medium effect size f2 025 of the active VR Using 2 tails and alpha 05 a fixed-effect linear regression model would offer power greater than 080 with a total sample size of 159 children To ensure adequate power the investigators planned to recruit 56 participants for each group Three groups were all operated by PICC specialist nurses and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines
From May 2020 to May 2021 children requiring PICC were recruited by convenience sampling and divided into three groups A B and C Group A was implanted with PICC under ultrasound guidance Group B and group C all used VR intervention and used VR equipment 5 minutes before the operation began Group B was anesthetized after the puncture needle was sent into the guide wire and group C was anesthetized before the puncture needle was sent into the guide wireThe success rate of one puncture pain fear compliance and catheterization time were compared among the three groups A sample size and power analysis were conducted to determine the sample size requiredThe investigators assumed a medium effect size f2 025 of the active VR Using 2 tails and alpha 05 a fixed-effect linear regression model would offer power greater than 080 with a total sample size of 159 children To ensure adequate power the investigators planned to recruit 56 participants for each group Three groups were all operated by PICC specialist nurses and the standard operation procedure of PICC catheterization was implemented in accordance with the infusion therapy nursing practice guidelines and implementation rules and the 2016 INS guidelines
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