Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449144
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
The Effect of Mindfulness Training on Postoperative Pain - A Solomon Four Group Design
Sponsor:
Bilecik Seyh Edebali Universitesi
Organization:
Bilecik Seyh Edebali Universitesi
Study Overview
Official Title:
The Effect of Mindfulness Training on Postoperative Pain - A Solomon Four Group Design
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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 clinical trial is to learn if mindfulness education works to reduce pain after inguinal hernia operation in adults The main questions it aims to answer are
Does mindfulness education reduce the pain level after inguinal hernia operation Does mindfulness education reduce the pain intrusion level after inguinal hernia operation Does mindfulness education reduce the fear of pain level after inguinal hernia operation
Participants will
Pain level pain intrusion and fear of pain levels will be determined 24 hours before surgery
Awareness training will be given before surgery Pain level pain intrusion and fear of pain levels will be determined 24 hours after surgery
Does mindfulness education reduce the pain level after inguinal hernia operation Does mindfulness education reduce the pain intrusion level after inguinal hernia operation Does mindfulness education reduce the fear of pain level after inguinal hernia operation
Participants will
Pain level pain intrusion and fear of pain levels will be determined 24 hours before surgery
Awareness training will be given before surgery Pain level pain intrusion and fear of pain levels will be determined 24 hours after surgery
Detailed Description:
Cognitive behavioral therapy and mindfulness-based therapies are successful practices in reducing anxiety and psychological distress Ghielen et al 2019 Mindfulness training includes teaching a range of meditation techniques as well as how to focus on the present moment in daily activities Monshat K amp Castle D J 2012 Mindfulness training given to patients undergoing hip replacement surgery has been shown to reduce postoperative pain and improve their physical functioning Dowsey et al 2019 Similarly it has been reported that mindfulness training given to patients who will undergo knee and hip replacement before surgery can prevent postoperative pain and opioid use Hanley et al 2021 In a study mindfulness training used in the management of pain after lumbar disc herniation surgery was found to be useful in managing postoperative pain Juneyoung et al 2019 Aromatherapy with lavender oil was found to be effective in reducing pain after inguinal hernia surgery Bagheri et al 2020 This suggests that in addition to pharmacological pain management non-pharmacological methods are also effective in pain management and can be used In a meta-analysis evaluating the effectiveness of mindfulness-based interventions in acute pain it was found that there was a lack of good quality evidence for the effectiveness of mindfulness-based interventions in reducing pain severity in clinical or experimental settings Shires et al 2020 It is stated that more rigorous large-scale studies conducted with pain populations are needed before cognitive behavioral therapies can be definitively recommended as first-line treatment for acute or chronic pain McClintock et al 2021 Therefore our study was planned to determine the effect of preoperative awareness training on postoperative pain in patients undergoing inguinal hernia repair surgery
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