Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649383
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Virtual Reality VR Could Be a Good Alternative to Relaxing or Pain-relieving Medication
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality for Elderly Patients in Anesthesia and Surgical Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 want to investigate whether Virtual Reality VR could be a good alternative to the relaxing or pain-relieving medications that are often used to alleviate anxiety when patients undergo surgery under local anesthesia
Detailed Description:
This study is a randomized controlled trial based on both quantitative and qualitative methods Inclusion criteria are elderly patients aged 65 years with an estimated surgery time of a maximum of 90 minutes who undergo surgerytreatment under local anesthesia and sedation Randomization is to either standard sedation or sedationVR Randomization is carried out using mixed sealed envelopes The studies will be conducted at the following locations
Hallands Hospital Kungsbacka Open inguinal hernia surgery with implant anesthesia type is infiltration anesthesia
Sahlgrenska Hospital Intervention cannulation of the groin and vascular surgery performed via cathetersguides on blood vessels liver pancreas and abdominal organs with anesthesia type infiltration
Alingsås Hospital Surgery on the hand arm lower extremity urology with anesthesia type block and infiltration
Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory STAI-S and pain assessment using a numerical rating scale NRS from 0-11
We also plan to use an objective marker for measuring anxiety-induced stress perioperatively such as heart rate variability or skin conductance measurement Postoperative data will include STAI-S NRS intraoperative sedative medication type and dosage in mgkg time to urination time to oral nutrition discharge time and time spent in the postoperative ward
The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery
The primary outcome measure is mgkg of propofol used intraoperatively or another sedative drug andor the amount of local anesthetic used in mg The secondary outcome measures are anxiety-induced stress perioperatively where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory STAI-S
Hallands Hospital Kungsbacka Open inguinal hernia surgery with implant anesthesia type is infiltration anesthesia
Sahlgrenska Hospital Intervention cannulation of the groin and vascular surgery performed via cathetersguides on blood vessels liver pancreas and abdominal organs with anesthesia type infiltration
Alingsås Hospital Surgery on the hand arm lower extremity urology with anesthesia type block and infiltration
Data collection will include baseline preoperative stress levels measured with The State-Trait Anxiety Inventory STAI-S and pain assessment using a numerical rating scale NRS from 0-11
We also plan to use an objective marker for measuring anxiety-induced stress perioperatively such as heart rate variability or skin conductance measurement Postoperative data will include STAI-S NRS intraoperative sedative medication type and dosage in mgkg time to urination time to oral nutrition discharge time and time spent in the postoperative ward
The patient will assess their well-being with the QoR 15 and NRS during the first five days postoperatively The patient will be contacted to schedule a follow-up individual interview with semi-structured questions via Zoom two weeks after the surgery
The primary outcome measure is mgkg of propofol used intraoperatively or another sedative drug andor the amount of local anesthetic used in mg The secondary outcome measures are anxiety-induced stress perioperatively where data collection will be conducted using EEG spectral edge frequency and The State-Trait Anxiety Inventory STAI-S
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