Psychoeducation for Pain

Overseen By Kennedi Childs

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Physical or mental incapacity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is psychoeducation for pain safe for humans?

Psychoeducation for pain, including various forms like mindfulness and pain focus, has been studied in different contexts and is generally considered safe for humans. It is often used alongside other treatments to help manage pain and improve mental well-being. ^{1 2 3 4 5}

How does the Psychoeducation for Pain treatment differ from other pain management treatments?

This treatment is unique because it combines brief psychoeducation (teaching about pain) with mindfulness (a mental practice focusing on the present moment) in varying durations, which is not commonly seen in standard pain management approaches. It emphasizes both meaning-focused and pain-focused mindfulness, offering a novel way to address pain perception and management. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Psychoeducation for Pain?

Research shows that psychoeducation can improve pain management by enhancing patient participation and decision-making in their care. Mindfulness training has been linked to better physical functioning in chronic pain, suggesting that combining these approaches could be beneficial. ^{1 8 9 10 11}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18 or older who are receiving pain treatment at the Tallahassee Orthopedic Center. It's not suitable for those unable to consent due to physical or mental incapacity.

Inclusion Criteria

Receiving pain treatment at Tallahassee Orthopedic Center

Understanding English instructions fluently

Exclusion Criteria

I am unable to give consent due to physical or mental reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Participants receive psychoeducation and mindfulness-based interventions in a clinic waiting room

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and anxiety immediately after the intervention

1 day

What Are the Treatments Tested in This Trial?

Interventions

• 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)
• 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)
• 2 Minutes of Psychoeducation with 1 Minute of Mindfulness
• Mindfulness without Psychoeducation
• Pain Psychoeducation

Trial Overview The study examines if teaching patients about mindfulness in an orthopedic clinic waiting room can enhance the pain relief they get from a brief mindfulness session. There are five different combinations of psychoeducation and mindfulness being tested.

How Is the Trial Designed?

Group I: Mindfulness without Psychoeducation Experimental Treatment 1 Intervention

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

Group II: 2 Minutes of Psychoeducation with 1 Minute of Mindfulness Experimental Treatment 1 Intervention

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Group III: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus) Experimental Treatment 1 Intervention

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

Group IV: 1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus) Experimental Treatment 1 Intervention

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

Group V: Pain Psychoeducation Active Control 1 Intervention

In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

The psychoeducational pain self-management intervention significantly improved pain management knowledge and self-efficacy among 21 cancer patients and 7 family caregivers, indicating its effectiveness in enhancing their ability to manage pain (p = 0.035 for knowledge, p = 0.007 for self-efficacy).

Support from a competent and trustworthy nurse was crucial in facilitating learning experiences, while health decline was identified as a barrier to effective pain self-management, highlighting the need for personalized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring learning processes associated with a cancer pain self-management intervention in patients and family caregivers: A mixed methods study. Valenta, S., Miaskowski, C., Spirig, R., et al.[2021]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

A study involving 219 veterans over 12 weeks showed high satisfaction with the 'Pain Education School' program, with participants reporting that the information was new, useful, and easy to understand.

Participants felt empowered to use the information learned in the program and were likely to recommend it to others, indicating its effectiveness in educating patients about managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mixed-method approach to veteran satisfaction with pain education. Watson, EC., Cosio, D., Lin, EH.[2014]

The Chronic Pain Self-Management Programme (CPSMP) was found to be feasible and well-received by participants, with over 75% recommending it to others, indicating its potential for broader implementation.

Participants in the CPSMP experienced significant and stable improvements in pain, disability, and psychological factors like anxiety and depression over a 5-month follow-up, although the overall changes were modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. Mehlsen, M., Heegaard, L., Frostholm, L.[2022]

A psychoeducational program consisting of eight weekly sessions significantly improved adjustment to cancer in stage I-II breast cancer patients, with participants showing increased 'fighting spirit' and decreased feelings of 'helplessness' and 'anxious preoccupation' after the intervention.

The study involved 76 women (38 in the experimental group and 38 in the control group) and demonstrated that while psychoeducation positively influenced emotional adjustment, it did not significantly affect levels of 'avoidance/denial' compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychoeducation intervention to improve adjustment to cancer among Turkish stage I-II breast cancer patients: a randomized controlled trial. Dastan, NB., Buzlu, S.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Exploring learning processes associated with a cancer pain self-management intervention in patients and family caregivers: A mixed methods study. [2021]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of online pain resources for health professionals: a systematic review with subset meta-analysis of educational intervention studies. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Education in Improving Cancer Pain Management: A Synthesis of Available Studies. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Mixed-method approach to veteran satisfaction with pain education. [2014]

6. Ireland pubmed.ncbi.nlm.nih.gov

A prospective evaluation of the Chronic Pain Self-Management Programme in a Danish population of chronic pain patients. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a psychoeducation program in an outpatient mental health center. [2021]

8. Thailand pubmed.ncbi.nlm.nih.gov

Psychoeducation intervention to improve adjustment to cancer among Turkish stage I-II breast cancer patients: a randomized controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

What is important in transdisciplinary pain neuroscience education? A qualitative study. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Content analysis of chronic pain content at three undergraduate medical schools in Ontario. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of perioperative pain science education on pain, psychological factors and physical functioning: A systematic review. [2022]