Clinical trial NCT04848428: Online Mindfulness-based Intervention to Prevent Chronic Pain
Official title: Feasibility and Preliminary Effects of a Tailored Web-based Mindfulness-based Intervention to Prevent Chronic Pain After Major Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Chronic Pain
Pain Catastrophizing
Pain, Acute
Keywords: postoperative pain
mindfulness
chronic pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm pilot RCT
Primary purpose: PREVENTION

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 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.

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 \[CABG\] 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Pain Intensity after intervention
timeFrame: pre-intervention, immediately after the intervention
measure: Change from baseline Pain interference after intervention
timeFrame: pre-intervention, immediately after the intervention
Secondary outcomes:
measure: Change from Baseline Mindfulness after intervention
timeFrame: pre-intervention, immediately after the intervention
measure: Change from baseline Chronic pain acceptance after intervention
timeFrame: pre-intervention, immediately after the intervention
measure: Change from Baseline Pain catastrophizing after intervention
timeFrame: pre-intervention, immediately after the intervention
Other outcomes:
measure: Patient perception of the intervention's effectiveness, appropriateness, suitability and willingness to adhere
timeFrame: immediately after intervention
measure: Incidence of refusal and dropout
timeFrame: during the intervention, through study completion (1 month)
measure: Treatment dosage
timeFrame: during the intervention, immediately after intervention, through study completion (1 month)
measure: Treatment adherence
timeFrame: during the intervention, immediately after intervention, through study completion (1 month)
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
Study officials:
affiliation: Florida State University
name: Geraldine Martorella, PhD
role: PRINCIPAL_INVESTIGATOR
References: