Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 11:10 PM
Study NCT ID:
NCT01866605
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2013-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Sponsor:
Melbourne Health
Organization:
Study Overview
Official Title:
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients are often anxious immediately before surgery. The investigators hypothesis is that a warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.
Detailed Description:
The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as required; and 3) forced-air warming, a cotton blanket and reassurance as required. The primary endpoint is a visual analog scale of anxiety.
Study Oversight
Has Oversight DMC:
False
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?: