Ignite Creation Date:
2024-05-06 @ 8:57 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02861170
Status:
WITHDRAWN
Last Update Posted:
2020-11-30
First Post:
2016-06-23
Brief Title:
Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
Effects of a Peri-operative Brief Mindfulness-based Intervention on Post-operative Pain and Disability Among Anxious Patients With Chronic Pain Undergoing Total Hip Arthroplasty - a Feasibility and Acceptability Pilot Randomized Controlled Trial
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was a pilot and after recruitment started it was determined to not be feasible Therefore study protocol will be reviewed to adjust for changes
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM
Brief Summary:
This study evaluates the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty
All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan
All participants will receive an educational brochure and links to videos containing strategies for coping with pain and anxiety The half of the participants who are allocated to the treatment arm will also receive a 10 minute mindfulness intervention called a body scan
Detailed Description:
Psychological distress or anxiety is common in patients awaiting surgical procedures and can have impact on both physical and mental health leading to significantly reduced quality of life It has been associated with a slower and more complicated postoperative recovery and has been established as an independent predictor of pain and pain related outcomes after surgery
Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population
With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty this pilot study has been developed to demonstrate proof of concept testrefine the intervention recruitment and data collection procedures and test the interventions acceptability in the peri-operative setting
Pharmacological interventions and provision of information about surgical processes are two ways that pre-operative anxiety is currently addressed Mindfulness-based interventions have shown positive results in reducing psychological distress and improving pain related outcomes and may be a promising treatment avenue to evaluate in a surgical population
With the goal of conducting a full-scale definitive trial to investigate the effectiveness of a brief mindfulness-based intervention on post-operative pain and disability among anxious patients with chronic pain undergoing total hip arthroplasty this pilot study has been developed to demonstrate proof of concept testrefine the intervention recruitment and data collection procedures and test the interventions acceptability in the peri-operative setting
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