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 trial explores how short psychoeducation sessions about mindfulness can affect pain relief for people waiting in an orthopedic clinic. It compares different combinations of psychoeducation and mindfulness exercises to determine which is most effective in easing pain. Participants will engage in various three-minute sessions, each combining listening and mindfulness practice. Ideal participants are those receiving pain treatment at Tallahassee Orthopedic Center who can understand English instructions fluently. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative pain relief methods.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness and psychoeducation treatments are generally safe and well-tolerated by most people. Mindfulness involves focusing on the present moment and can help reduce stress and pain. Some evidence suggests that mindfulness might cause mild side effects like anxiety or discomfort, but these are rare.

Psychoeducation helps individuals learn about their condition and manage it better. It is also considered safe, with no significant risks reported.

For the mindfulness sessions in this trial, studies have found that these short sessions are easy to conduct and offer potential benefits without major safety concerns. Overall, these treatments appear safe for most participants, with only minor risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Psychoeducation for Pain trial because it explores innovative ways to manage pain using mindfulness and psychoeducation techniques. Unlike conventional pain treatments like medications or physical therapies, these approaches involve short, guided sessions that combine mindfulness practices with educational insights about pain. The trial's unique focus on personalized mindfulness — targeting either pain or personal meaning — offers a fresh perspective, potentially helping people cope with pain more effectively and quickly. Additionally, the simplicity and brevity of these techniques make them accessible and easy to integrate into daily life, which could be a game-changer for those seeking alternative pain management strategies.

What evidence suggests that this trial's treatments could be effective for pain relief?

Research has shown that mindfulness exercises can help reduce pain. Studies have found that short mindfulness practices can lower pain intensity and improve pain management. For instance, one study discovered that mindfulness reduced pain intensity by 27% and made it feel 44% less unpleasant compared to other methods. Additionally, mindfulness-based therapy has been shown to lower stress and improve mental health, aiding in pain management. This trial will explore various approaches, including combining mindfulness with educational sessions about pain, to determine their effectiveness in improving pain management. Participants will be randomized into different treatment arms, such as "1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)" and "Mindfulness without Psychoeducation," to evaluate these strategies. ^{1 6 7 8 9}

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 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]

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]

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]

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]

Citations

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Brief Mindfulness-Based Interventions for Acute and ... Mindfulness group reported improvements in all four outcomes (ds ranged from 0.17 [desire for opioids] to 0.98 [anxiety], ps < 0.05). Mindfulness outperformed ...

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Mindfulness exercises Practicing mindfulness involves breathing methods, guided imagery, and other practices to relax the body and mind and help reduce stress.

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The Effectiveness of Mindfulness-Based Stress Reduction ... The reviewed literature suggested that MBSR was effective in reducing HCPs experiences of anxiety, depression and stress.

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Mindfulness-Based Psychotherapy Approaches for First ... Mindfulness-based interventions have been shown to directly promote first responders' mental and physical health while providing increased resilience.

9. dovepress.com dovepress.com/article/download/52468

The Effectiveness of a Mindfulness-Based ... The objective of this study was to find out whether the MBPP would be feasible for improving the emotion regulation of these patients, in terms of rumination,.