Online Mindfulness-based Intervention to Prevent Chronic Pain

Chronic Pain Clinical Trial

Official title:

Feasibility and Preliminary Effects of a Tailored Web-based Mindfulness-based Intervention to Prevent Chronic Pain After Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848428
• Other study ID #: 046073
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: November 29, 2022

Study information

• Verified date: January 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 subacute/rehabilitation phase after major surgery. Further, these interventions are demanding and not tailored. Previous work from the Principal Investigator in the acute/hospitalization 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 acceptability/feasibility 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.

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] or/and 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 surgeon's 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 1:1 will be used to generate a list through computer software. The list and envelopes will be prepared by a PI's 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 --i.e., 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. Student's 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 0,05 will be used for all analyses. If interactions are found (p<0,05), post-hoc comparisons will be performed. Lastly, qualitative data obtained from individual interviews will be content analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 29, 2022
• Est. primary completion date: August 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age = 18 years

• first-time elective CABG and/or VR via a median sternotomy OR total knee or hip replacement

• presence of pain at movement =4/10

• ability to understand and complete questionnaires in English

• ability to use an electronic device such as a smartphone, computer or tablet

Exclusion Criteria:

• unable to consent because of physical or mental incapacity.

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Pain Catastrophizing
• Pain, Acute
• Pain, Postoperative

Intervention

Behavioral:
• Online mindfulness-based cognitive therapy
The first session will first focus on providing feedback regarding post-surgical pain. The second session will focus on teaching mindfulness strategies. The third session will focus on practicing one of the two strategies. Of note, sessions 2 and 3 will start with cognitive restructuring strategies for the moderate-high risk profile patients. The 4th session consists in a booster providing feedback and reminders about cognitive reactions to pain and mindfulness meditation. The participants will be asked to practice meditation 5 days a week, for a total of 4 weeks
• Online standardized education
One 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies.

Locations

Country	Name	City	State
United States	Tallahassee Memorial Hospital	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient perception of the intervention's effectiveness, appropriateness, suitability and willingness to adhere	The intervention acceptability will be rated using the Treatment Acceptability and Preferences (TAP) questionnaire which consists in a 5-point Likert scale regarding four attributes: 1) appropriateness in helping patients manage pain, 2) effectiveness in promoting pain management, 3) suitability and, 4) willingness to adhere, with the use of the Treatment Acceptability and Preference (TAP) measure.The ratings refer to a 5-point scale ranging from not at all (0) to very much (4). Additionally,thirty-minute semi-structured individual interviews (telephone or videoconference) will be then conducted by the RA. Patients' rating of each component will be used to solicit feedback on the intervention's acceptability and on the need for further modifications. Interviews will be digitally recorded and transcribed by a trained RA.	immediately after intervention
Other	Incidence of refusal and dropout	percentages of refusal and dropout as well as reasons will be reported	during the intervention, through study completion (1 month)
Other	Treatment dosage	percentages of participants completing the sessions according to the planned schedule will be assessed through Website monitoring	during the intervention, immediately after intervention, through study completion (1 month)
Other	Treatment adherence	number of times the sessions were accessed by participants	during the intervention, immediately after intervention, through study completion (1 month)
Primary	Change from baseline Pain Intensity after intervention	0-10 Numerical Rating Scale (Brief Pain Inventory)	pre-intervention, immediately after the intervention
Primary	Change from baseline Pain interference after intervention	0-10 Numerical Rating Scale (Brief Pain Inventory) several daily activities such as housework, sleep, etc	pre-intervention, immediately after the intervention
Secondary	Change from Baseline Mindfulness after intervention	The Cognitive and Affective Mindfulness Scale-Revised (CAMS-R): 12-item scale This scale captures the broad concept of mindfulness according to 4 domains (attention, present focus, awareness, acceptance/non-judgement) without being specific to any particular meditation or strategy.	pre-intervention, immediately after the intervention
Secondary	Change from baseline Chronic pain acceptance after intervention	Chronic Pain Acceptance Questionnaire (CPAQ-8): 8-item scaleThis scale comprises two subscales: the degree to which patients engage in daily living activities regardless of pain (4 items), and the willingness to experience pain (4 items).	pre-intervention, immediately after the intervention
Secondary	Change from Baseline Pain catastrophizing after intervention	The Pain Catastrophizing Scale (PCS) includes 13 items and will be used to assess patients' pain-related catastrophic thoughts. It includes 13 items divided into three subscales: rumination (4 items), magnification (3 items) and helplessness (6 items). Each item is rated on a 5-point scale with the end points "not at all" (0) and "all the time" (4).	pre-intervention, immediately after the intervention