Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180486
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-12-12
Brief Title:
Mindfulness Meditation Intervention Study
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Preoperative Mindfulness Meditation for Total Knee Arthroplasty A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls and if a preop mindfulness meditation intervention can train resilience The main questions it aims to answer are
1 Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery
2 Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study
3 Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls Can preoperative a mindfulness meditation intervention train resilience as measured by increased resilience score
Participants will be randomly assigned to be in the intervention group or the waitlist control group The intervention group gets the mindfulness mediation intervention prior to their day of surgery and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days
1 Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery
2 Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study
3 Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls Can preoperative a mindfulness meditation intervention train resilience as measured by increased resilience score
Participants will be randomly assigned to be in the intervention group or the waitlist control group The intervention group gets the mindfulness mediation intervention prior to their day of surgery and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days
Detailed Description:
This study will investigate the effect of a preoperative mindfulness meditation intervention MMI on outcomes for total knee arthroplasty TKA patients at the Hospital for Special Surgery in a randomized controlled trial Mindfulness meditation is a practice well-known to psychology research based on sustained attention on the present and a non-judgment of ones current situation It has been used for numerous psychological issues including stress anxiety and depression This intervention group will be compared against a waitlist control group patients will be told they are on a waitlist to receive the mindfulness intervention which will occur after data collection has finished for their group This control has been utilized in several mindfulness meditation studies
Measures of anxiety depression resilience pain and pain unpleasantness and overall physical and mental health will be taken after randomization but before the intervention or being told they are on the waitlist Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls and if a preop mindfulness meditation intervention can train resilience The main questions it aims to answer are
1 Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery
2 Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study
3 Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls Can preoperative a mindfulness meditation intervention train resilience as measured by increased resilience score
Participants will be randomly assigned to be in the intervention group or the waitlist control group The intervention group gets the mindfulness mediation intervention prior to their day of surgery and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days
Measures of anxiety depression resilience pain and pain unpleasantness and overall physical and mental health will be taken after randomization but before the intervention or being told they are on the waitlist Overall physical and mental health measures will also be taken on the day of surgery and final surveys will be collected at 90 days post-op
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls and if a preop mindfulness meditation intervention can train resilience The main questions it aims to answer are
1 Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery
2 Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study
3 Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls Can preoperative a mindfulness meditation intervention train resilience as measured by increased resilience score
Participants will be randomly assigned to be in the intervention group or the waitlist control group The intervention group gets the mindfulness mediation intervention prior to their day of surgery and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery
The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days
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