Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502121
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2020-06-23
Brief Title:
Preoperative Optimization of Cardiac Valve Patients Expectations
Sponsor:
Philipps University Marburg Medical Center
Organization:
Philipps University Marburg Medical Center
Study Overview
Official Title:
Preoperative Optimization of Cardiac Valve Patients Expectations - a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
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:
ValvEx
Brief Summary:
Recovery after surgery depends on psychological factors such as preoperative information expectations and surgery-associated anxiety Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients However what content works best for which patient group and how long an intervention has to be is still largely unknown The aims of this study are thus to examine if the developed preoperative psychological intervention i reduces preoperative anxiety ii increases positive expectations and iii improves the long-term outcome postoperative recovery Therefore a brief intervention has been developed Heart valve patients who undergo a heart surgery will be randomized into two groups Control vs intervention group after baseline assessment Following this the intervention group will participate in the psychological intervention 30-40 minutes To increase patients positive expectations the intervention will focus on treatment outcome expectations and personal control expectations Furthermore patients in the intervention group will have two booster-telephone calls four and eight weeks after the surgery to check if their developed plans work out The control group will receive the standard medical procedure Both groups will fill out questionnaires again at the evening before the surgery around one week after the surgery and three months after surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None