Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429072
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-01
First Post:
2024-03-04
Brief Title:
Integration of Mindfulness and Acupuncture After Spine Surgery
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Integration of Mindfulness and Acupuncture After Spine Surgery Aim 2
Status:
ENROLLING_BY_INVITATION
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:
I-MASS
Brief Summary:
The Integration of Mindfulness and Acupuncture for individuals undergoing Spine Surgery I-MASS is a novel combination of integrative treatments to improve post-surgical recovery
This is a single-site two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app the mHealth platform used for delivering mindfulness training and collecting data Outcomes will focus on feasibility and acceptability of I-MASS feasibility of recruitment and retention strategies and data collection procedures through both the Pattern Health app and electronic health record Feasibility will be supported by mindfulness module completion rates acupuncture visits attended participant retention and questionnaire completion rates Acceptability will be supported by patient-reported satisfaction acceptability and usability thresholds
This is a single-site two-arm randomized feasibility and acceptability pilot trial of the I-MASS program plus enhanced patient education compared to enhanced patient education alone in patients undergoing spine surgery Outcomes data will come from a combination of passive electronic health record data augmented with patient-reported data collected through the Pattern Health app the mHealth platform used for delivering mindfulness training and collecting data Outcomes will focus on feasibility and acceptability of I-MASS feasibility of recruitment and retention strategies and data collection procedures through both the Pattern Health app and electronic health record Feasibility will be supported by mindfulness module completion rates acupuncture visits attended participant retention and questionnaire completion rates Acceptability will be supported by patient-reported satisfaction acceptability and usability thresholds
Detailed Description:
Participants will be randomized to one of two study arms 1 the I-MASS program plus enhanced education or 2 the enhanced education intervention only
I-MASS program plus enhanced education Intervention Arm This arm begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app discuss the benefits of combining mindfulness and acupuncture discuss how to access the Healthwise educational content and lead a brief 10 min mindfulness exercise as desired Thereafter participants will complete 4 self-directed mindfulness modules through the Pattern Health app 1 prior to surgery 3 following surgery The modules will include a guided series of videos audio files and interactive text features Each week-long module includes daily sessions comprised of a short 4-5 min background video a 6-8 min guided mediation users could choose either a female or male voice and interactive suggestions for how to apply mindfulness within their daily routine 10-12 min total per session The pre-operative training module 1 focuses on developing an awareness of breath which is a fundamental mindfulness technique Following surgery participants will initiate training module 2 building awareness of body systems followed by modules 3 and 4 over the subsequent 2 weeks Automated activity reminders in the app will alert the participant to complete the daily session Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules
The initial acupuncture session will occur within one week prior to surgery The second acupuncture session will occur within the first week following surgery Afterwards participants will receive acupuncture in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between acupuncture sessions Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain giving participants an opportunity to reflect on their experiences during the acupuncture session Auricular acupuncture will be the preferred form of acupuncture used If participants are unable to tolerate auricular acupuncture they will have the option to receive peripheral acupuncture
The program consists of enhanced education prior to and after surgery for all participants All of the educational material is delivered via the Pattern Health App All educational content is from the Healtwisenet Duke Health Library httpswwwhealthwisenetdukehealthContent and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery Educational topics include learning how to lift and sit when experiencing pain proper precautions following surgery how to ease back into daily activities following surgery and ways to self-manage pain Education is in the form of short reading materials or videos all designed to help safely and effectively recover from surgery
Enhanced Education Arm Participants in this arm will receive an introductory call from study staff to introduce the participant to the Pattern Health app discuss how to access the Healthwise educational content and answer any questions about the program They will then receive the same course of enhanced educational material as the Intervention arm in the Pattern Health app
All trial participants will not be prevented from receiving any other care deemed necessary by their health care team and surgeon This program is designed to complement their usual care not replace it Participant involvement with the study will be complete at 3 months following surgery All follow-up questionnaires will be administered through the Pattern Health app for participants in both study arms
I-MASS program plus enhanced education Intervention Arm This arm begins with one introductory telephone call by a mindfulness coach within 1 week of the patient scheduling surgery to introduce the participant to the Pattern Health app discuss the benefits of combining mindfulness and acupuncture discuss how to access the Healthwise educational content and lead a brief 10 min mindfulness exercise as desired Thereafter participants will complete 4 self-directed mindfulness modules through the Pattern Health app 1 prior to surgery 3 following surgery The modules will include a guided series of videos audio files and interactive text features Each week-long module includes daily sessions comprised of a short 4-5 min background video a 6-8 min guided mediation users could choose either a female or male voice and interactive suggestions for how to apply mindfulness within their daily routine 10-12 min total per session The pre-operative training module 1 focuses on developing an awareness of breath which is a fundamental mindfulness technique Following surgery participants will initiate training module 2 building awareness of body systems followed by modules 3 and 4 over the subsequent 2 weeks Automated activity reminders in the app will alert the participant to complete the daily session Each module builds upon skills learned in the previous module and participants are encouraged to continue using learned skills and resources within the app after completion of the modules
The initial acupuncture session will occur within one week prior to surgery The second acupuncture session will occur within the first week following surgery Afterwards participants will receive acupuncture in participating community outpatient clinics for up to 8 sessions total within 12 weeks of surgery The investigators will allow flexibility in scheduling these visits with a window of 5-10 days between acupuncture sessions Acupuncturists will also be trained to facilitate discussion about mindful awareness and non-judgmental thoughts regarding pain giving participants an opportunity to reflect on their experiences during the acupuncture session Auricular acupuncture will be the preferred form of acupuncture used If participants are unable to tolerate auricular acupuncture they will have the option to receive peripheral acupuncture
The program consists of enhanced education prior to and after surgery for all participants All of the educational material is delivered via the Pattern Health App All educational content is from the Healtwisenet Duke Health Library httpswwwhealthwisenetdukehealthContent and is carefully selected with input by surgeons to be delivered during the appropriate phase of recovery Educational topics include learning how to lift and sit when experiencing pain proper precautions following surgery how to ease back into daily activities following surgery and ways to self-manage pain Education is in the form of short reading materials or videos all designed to help safely and effectively recover from surgery
Enhanced Education Arm Participants in this arm will receive an introductory call from study staff to introduce the participant to the Pattern Health app discuss how to access the Healthwise educational content and answer any questions about the program They will then receive the same course of enhanced educational material as the Intervention arm in the Pattern Health app
All trial participants will not be prevented from receiving any other care deemed necessary by their health care team and surgeon This program is designed to complement their usual care not replace it Participant involvement with the study will be complete at 3 months following surgery All follow-up questionnaires will be administered through the Pattern Health app for participants in both study arms
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