Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT06858202
Status:
RECRUITING
Last Update Posted:
2025-03-05
First Post:
2025-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Determine How Different Types of Coping Strategies Can Help People Manage Pain and Distress After Surgery
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Quality Improvement Project to Address Post Operative Distress and Pain for Patients Undergoing Surgery for Intra-Abdominal Malignancies
Status:
RECRUITING
Status Verified Date:
2025-02
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:
The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer.
The main questions this study aims to answer are:
* Is it possible to use video-based coping strategies to help manage pain and distress after surgery?
* Is one type of coping strategy better than another?
Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.
Participants will:
* Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.
* Fill out some questionnaires before surgery, which should take 10-15 minutes.
* Be assigned to one of three coping strategies.
* Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.
* Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.
* Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.
The main questions this study aims to answer are:
* Is it possible to use video-based coping strategies to help manage pain and distress after surgery?
* Is one type of coping strategy better than another?
Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.
Participants will:
* Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.
* Fill out some questionnaires before surgery, which should take 10-15 minutes.
* Be assigned to one of three coping strategies.
* Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.
* Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.
* Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.
Detailed Description:
We propose to conduct a quality improvement project to determine the impact of different types of psychosocial support for patients undergoing surgery for intrabdominal malignancies.
This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.
Objectives:
Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.
Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.
Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.
Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.
This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.
Objectives:
Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.
Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.
Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.
Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: