Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04848428
Status:
COMPLETED
Last Update Posted:
2023-02-01
First Post:
2021-04-07
Brief Title:
Online Mindfulness-based Intervention to Prevent Chronic Pain
Sponsor:
Florida State University
Organization:
Florida State University
Study Overview
Official Title:
Feasibility and Preliminary Effects of a Tailored Web-based Mindfulness-based Intervention to Prevent Chronic Pain After Major Surgery
Status:
COMPLETED
Status Verified Date:
2023-01
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:
Cardiac and orthopedic surgeries are frequent procedures However pain after a major surgery may become chronic lasting 3 months in adults Once discharged from the hospital patients are at risk for chronic post-surgical pain CPSP and prolonged opioid use as they become isolated with high levels of pain Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance will determine their ability to cope and their opioid use which makes a support for pain self-management crucial There is limited research on psychological interventions for pain in the subacuterehabilitation phase after major surgery Further these interventions are demanding and not tailored Previous work from the Principal Investigator in the acutehospitalization phase shows that a brief Web-based intervention tailored to modifiable psychological factors may modulate these and reduce postoperative pain interference Recently studies on mindfulness-based cognitive therapy MBCT have multiplied regarding their potential effect on pain acceptance and catastrophic thoughts Brief Web-based MBCT for the prevention of CPSP have not been examined Therefore a pilot test of a 4-week tailored Web-based MBCT intervention for adults in the rehabilitation phase will be conducted by 1 assessing the acceptabilityfeasibility of the intervention and 2 examining preliminary effects on pain intensity and pain interference with activities as well as pain acceptance and catastrophic thoughts This research is significant because it targets the trajectory of CPSP a leading cause of disability and opioid misuse This approach is innovative because it promotes pain self-management through the modulation of individual factors If successful the intervention could be expanded to numerous populations at risk for chronic pain
Detailed Description:
A single blinded pilot randomized controlled trial will be used to assess preliminary efficacy of the Web-based MBCT intervention following major surgery Coronary Artery Bypass Grafting CABG orand Valve Replacement VR Total knee or hip replacement An experienced research assistant RA will be responsible of participants recruitment and informed consent procedures at the time of follow-up usually 2 weeks after surgery The study will be advertised on the rehabilitation units and surgeons offices with posters and flyers If interested clinical team will contact the RA and inclusion criteria will be assessed After having collected baseline measures participants will be randomized into two groups by the principal investigator PI one receiving both the 4-week Web-based MBCT intervention and the usual care procedure Experimental Group EG the other one receiving solely one standardized educational online session and the usual care procedure Control Group CG Participants from the CG will be given the opportunity to receive the entire intervention once the study will be completed
Permuted-block randomization with an allocation ratio of 11 will be used to generate a list through computer software The list and envelopes will be prepared by a PIs colleague who will not be involved in this study The RA who will be responsible of the entire data collection will be blinded to patient group assignment
All participants will complete baseline measures via a telephone interview or a Qualtrics survey T0 Usual socio-demographic variables --ie age sex civil status living conditions education level and employment status will be assessed Considering the reciprocity between pain and anxiety and depression measures will be taken with the PHQ-4 before intervention T0 and after intervention T1 Presence of chronic pain before surgery will be documented as well Analgesic medication intake will be documented at all time points The protocol will favor an intention-to-treat approach for the analysis of results Participants flow will be reported according to the CONSORT guidelines for psychological interventions Students t-tests or chi-square tests will be performed for each socio-demographic medico-surgical and baseline psychological variables to assure that equivalence of groups was obtained through randomization although this procedure is not mandatory The statistical analysis will be mostly descriptive mean standard deviation for continuous outcomes and frequency and proportion for categorical outcomes with 95 confidence intervals when appropriate Pain intensity pain interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being scores will be summarized using descriptive statistics presented per group at each time point Further treatment effect will be estimated and presented with 95 CI at each time point A first set of exploratory analysis will be carried out to compare the evolution of pain intensity pain interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being in each group through the use of two-way ANOVA with repeated measures pre-intervention post-intervention A second set of analyses will assess the impact of the intervention on the prevalence and severity of CPSP pain intensity and interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being Repeated measures ANOVA and repeated measures logistic regression will be performed to compare groups for illustrative purposes since the study is not powered to show statistical significance An alpha level of significance of 005 will be used for all analyses If interactions are found p005 post-hoc comparisons will be performed Lastly qualitative data obtained from individual interviews will be content analyzed
Permuted-block randomization with an allocation ratio of 11 will be used to generate a list through computer software The list and envelopes will be prepared by a PIs colleague who will not be involved in this study The RA who will be responsible of the entire data collection will be blinded to patient group assignment
All participants will complete baseline measures via a telephone interview or a Qualtrics survey T0 Usual socio-demographic variables --ie age sex civil status living conditions education level and employment status will be assessed Considering the reciprocity between pain and anxiety and depression measures will be taken with the PHQ-4 before intervention T0 and after intervention T1 Presence of chronic pain before surgery will be documented as well Analgesic medication intake will be documented at all time points The protocol will favor an intention-to-treat approach for the analysis of results Participants flow will be reported according to the CONSORT guidelines for psychological interventions Students t-tests or chi-square tests will be performed for each socio-demographic medico-surgical and baseline psychological variables to assure that equivalence of groups was obtained through randomization although this procedure is not mandatory The statistical analysis will be mostly descriptive mean standard deviation for continuous outcomes and frequency and proportion for categorical outcomes with 95 confidence intervals when appropriate Pain intensity pain interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being scores will be summarized using descriptive statistics presented per group at each time point Further treatment effect will be estimated and presented with 95 CI at each time point A first set of exploratory analysis will be carried out to compare the evolution of pain intensity pain interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being in each group through the use of two-way ANOVA with repeated measures pre-intervention post-intervention A second set of analyses will assess the impact of the intervention on the prevalence and severity of CPSP pain intensity and interference mindfulness pain acceptance pain-related catastrophic thoughts and psychological well-being Repeated measures ANOVA and repeated measures logistic regression will be performed to compare groups for illustrative purposes since the study is not powered to show statistical significance An alpha level of significance of 005 will be used for all analyses If interactions are found p005 post-hoc comparisons will be performed Lastly qualitative data obtained from individual interviews will be content analyzed
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