Pain, PostoperativeNCT04848428
Online Mindfulness-based Intervention to Prevent Chronic Pain
A study testing Online mindfulness-based cognitive therapy and Online standardized education in people with Pain, Postoperative and Chronic Pain, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Chronic Pain, Pain Catastrophizing
- What is being tested?
- Online mindfulness-based cognitive therapy and Online standardized education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 29 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to consent because of physical or mental incapacity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Memorial Hospital
Tallahassee, Florida, 32306
About this study
Official title: Feasibility and Preliminary Effects of a Tailored Web-based Mindfulness-based Intervention to Prevent Chronic Pain After Major Surgery
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.
Read the 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.
- Conditions
- Pain, Postoperative, Chronic Pain, Pain Catastrophizing, Pain, Acute
- Being tested
- Online mindfulness-based cognitive therapy, Online standardized education
- Keywords
- postoperative pain, mindfulness, chronic pain
- Medical subject headings
- Pain, Postoperative, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online mindfulness-based cognitive therapyBehavioural
Also called Online MBCT
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 educationBehavioural
One 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies.
| Study group | Role | What they receive |
|---|---|---|
| Online Mindfulness-based intervention | Experimental | Four weekly sessions are planned. The first session will 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. 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 Receives: Behavioral: Online mindfulness-based cognitive therapy |
| Online standardized education | Active comparator | In addition to usual care, the CG will have access to one 15-minute standardized educational online session on persistent post-surgical pain, how pain and stress may interact and their potential impact on recovery. Receives: Behavioral: Online standardized education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Pain Intensity after intervention
0-10 Numerical Rating Scale (Brief Pain Inventory)
Measured: pre-intervention, immediately after the intervention
Change from baseline Pain interference after intervention
0-10 Numerical Rating Scale (Brief Pain Inventory) several daily activities such as housework, sleep, etc
Measured: pre-intervention, immediately after the intervention
Secondary outcomes (3)
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.
Measured: pre-intervention, immediately after the intervention
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).
Measured: pre-intervention, immediately after the intervention
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).
Measured: pre-intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 May 2021
- Primary completion29 Aug 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm pilot RCT
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geraldine Martorella, Florida State University
- Investigators
- Geraldine Martorella, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848428
- Sponsor's protocol ID
- 046073
- Status last verified
- Jan 2023
- First submitted
- 7 Apr 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Martorella G, Hanley AW, Muessig KE. Patients' Perception of a Brief Web- and Mindfulness-Based Intervention for Pain Following Discharge After Total Joint Arthroplasty: Qualitative Description. JMIR Nurs. 2025 Aug 6;8:e69010. doi: 10.2196/69010.
PubMed 40768766
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effects of a Tailored Web-based Mindfulness-based Intervention to Prevent Chronic Pain After Major Surgery
- ClinicalTrials.gov ID
- NCT04848428
- Acronym / sponsor ID
- 046073
- Conditions
- Pain, Postoperative, Chronic Pain, Pain Catastrophizing, Pain, Acute
- Keywords
- postoperative pain, mindfulness, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm pilot RCT
| Arm | Type | Receives |
|---|---|---|
| Online Mindfulness-based intervention | Experimental | Behavioral: Online mindfulness-based cognitive therapyFour weekly sessions are planned. The first session will 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. 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 | Active comparator | Behavioral: Online standardized educationIn addition to usual care, the CG will have access to one 15-minute standardized educational online session on persistent post-surgical pain, how pain and stress may interact and their potential impact on recovery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- unable to consent because of physical or mental incapacity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online mindfulness-based cognitive therapyAlso: Online MBCTThe 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 | Behavioural | Online Mindfulness-based intervention |
| Online standardized educationOne 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies. | Behavioural | Online standardized education |
Primary outcome
Change from baseline Pain Intensity after intervention
Time frame: pre-intervention, immediately after the intervention
0-10 Numerical Rating Scale (Brief Pain Inventory)
Change from baseline Pain interference after intervention
Time frame: pre-intervention, immediately after the intervention
0-10 Numerical Rating Scale (Brief Pain Inventory) several daily activities such as housework, sleep, etc
3 secondary outcomes
Change from Baseline Mindfulness after intervention
Time frame: pre-intervention, immediately after the intervention
Change from baseline Chronic pain acceptance after intervention
Time frame: pre-intervention, immediately after the intervention
Change from Baseline Pain catastrophizing after intervention
Time frame: pre-intervention, immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Derived from this study: PubMed 40768766Martorella G, Hanley AW, Muessig KE. Patients' Perception of a Brief Web- and Mindfulness-Based Intervention for Pain Following Discharge After Total Joint Arthroplasty: Qualitative Description. JMIR Nurs. 2025 Aug 6;8:e69010. doi: 10.2196/69010.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geraldine Martorella, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online mindfulness-based cognitive therapy and Online standardized education in people with Pain, Postoperative and Chronic Pain, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Pain Intensity after intervention (time frame: pre-intervention, immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.