Mindfulness App for Hip Surgery Recovery

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Schizophrenia, Bipolar, Schizoaffective, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Hip preservation surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting effects such as muscle weakness or diminished joint function, hip pain, and fear. Many of these patients report greater anxiety and depression following surgery, which can further compound negative outcomes in these patients. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes following hip preservation surgery.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Healthy Minds Program (HMP) App for hip surgery recovery?

Research shows that mindfulness interventions, like the Healthy Minds Program App, can improve mental health and reduce stress in surgical patients. Additionally, mindfulness exercises have been associated with increased patient satisfaction and potentially better recovery outcomes in various surgical settings. ^{1 2 3 4 5}

Is the Mindfulness App safe for use in humans?

The Mindfulness App has been used safely in various studies, including with surgical patients and military personnel, showing positive feedback on mental health and stress levels without any reported safety issues. ^{2 3 4 6 7}

How does the mindfulness app treatment for hip surgery recovery differ from other treatments?

The mindfulness app treatment is unique because it uses a digital platform to deliver mindfulness exercises, which can help reduce stress and improve mental health during recovery from hip surgery. Unlike traditional pain management methods that often rely on medications, this app-based approach offers a non-drug alternative that can be easily accessed and used by patients at their convenience. ^{1 3 5 8 9}

Research Team

Andrew Watson, MD, MS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for individuals aged 18-45 who are undergoing hip preservation surgery and have access to a mobile device. They should not have significant prior experience with meditation or mindfulness, nor a history of serious mental illness like schizophrenia or bipolar disorder.

Inclusion Criteria

Participation in study 2019-0363

Access to a mobile device compatible with the freely available Healthy Minds Program (HMP) App (Android or iOS)

Exclusion Criteria

I have practiced meditation or mindfulness for more than 30 minutes a month in the last year.

Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week mindfulness intervention delivered remotely via a mobile app following hip preservation surgery

8 weeks

Remote participation

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

Assessments at baseline, 3, 6, 12, and 24 months

Treatment Details

Interventions

• Healthy Minds Program (HMP) App

Trial Overview The study tests the impact of an 8-week mindfulness program delivered through the Healthy Minds Program App on patient outcomes after hip surgery. It's a single-blind trial where patients don't know if they're using the actual app or a control version.

Participant Groups

Group I: Mindfulness Intervention plus Standard of Care Experimental Treatment 1 Intervention

The Foundations and Awareness modules of the HMP app require a minimum of 133 and 253 minutes, equating to less than 5 and less than 10 minutes per day on average, respectively. Date, duration, and content of usage will be recorded for each participant through the app. Participants will have access to the entire contents of the app for the full duration of the study.

Group II: Standard of Care Active Control 1 Intervention

Control group receives standard of care only

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

A mind-body program using guided imagery and relaxation techniques significantly reduced anxiety levels in surgical patients on the night of their surgery, based on a study of 230 patients undergoing various procedures.

While there was a trend towards lower pain scores and improved sleep quality in the intervention group, these differences were not statistically significant; however, a majority of patients found the program helpful and expressed willingness to use it again for future surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing for successful surgery: an implementation study. Diaz, M., Larsen, B.[2022]

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

In a study involving cardiac surgical patients, a mindfulness program was implemented pre- and postoperatively, resulting in no patients screening positive for postoperative delirium, suggesting a potential benefit of mindfulness in this context.

Both mindfulness and informational audio groups reported lower anxiety and depression scores post-surgery, along with higher satisfaction ratings regarding their hospital experience, indicating that mindfulness exercises may enhance overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Delirium and Improving Patient Satisfaction With a Perioperative Mindfulness Intervention: A Mixed-Methods Pilot Study. Lisann-Goldman, LR., Pagnini, F., Deiner, SG., et al.[2019]

A brief, 60-second mindfulness video was highly feasible and well-received by all 20 participants in an orthopedic surgical practice, indicating its practicality for busy settings.

Participants experienced significant reductions in pain intensity, state anxiety, and negative emotions like distress and anger after watching the video, suggesting it could be an effective adjunct to traditional pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Use of a Brief 60-second Mindfulness Exercise in an Orthopedic Surgical Practice; Results from a Pilot Study. Chad-Friedman, E., Talaei-Khoei, M., Ring, D., et al.[2022]

The use of the Headspace® meditation app by anesthesia trainees led to significant reductions in depression scores and increased feelings of personal achievement after 1 and 4 months of use, indicating its potential as a well-being tool.

Despite the positive effects on depression and personal achievement, the app did not significantly reduce burnout symptoms related to emotional exhaustion and depersonalization, suggesting that while mindfulness may help with certain aspects of well-being, it may not fully address all dimensions of burnout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a smartphone meditation application on anesthesia trainee well-being. Carullo, PC., Ungerman, EA., Metro, DG., et al.[2022]

The PHIT for Duty mobile app, designed for military personnel with subclinical psychological issues, received high usability ratings (average score of 4.5 out of 5) and a System Usability Scale score of 85, indicating excellent user satisfaction.

The app effectively integrates mindfulness techniques and health assessments, showing a strong correlation (r = 0.87) with traditional paper forms, suggesting it is a reliable tool for health research in the military context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation. Kizakevich, PN., Eckhoff, R., Brown, J., et al.[2019]

A mindfulness-based phone application significantly reduced stress, anxiety, and burnout in orthopaedic surgery residents after just 2 months of use, with participants averaging only 8 minutes of use per day, 2 days a week.

The treatment group, which started with higher baseline stress and anxiety, showed notable improvements in emotional exhaustion and depersonalization, indicating that mindfulness techniques may be especially beneficial for those experiencing higher levels of stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Applications: Can They Serve as a Stress, Anxiety, and Burnout Reduction Tool in Orthopaedic Surgery Training? A Randomized Control Trial. Boden, LM., Rodriguez, C., Kelly, JD., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: study protocol for a randomised controlled trial. [2021]

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

Preparing for successful surgery: an implementation study. [2022]

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

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]

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

Reducing Delirium and Improving Patient Satisfaction With a Perioperative Mindfulness Intervention: A Mixed-Methods Pilot Study. [2019]

5. Iran pubmed.ncbi.nlm.nih.gov

First Use of a Brief 60-second Mindfulness Exercise in an Orthopedic Surgical Practice; Results from a Pilot Study. [2022]

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

The impact of a smartphone meditation application on anesthesia trainee well-being. [2022]

7. England pubmed.ncbi.nlm.nih.gov

PHIT for Duty, a Mobile Application for Stress Reduction, Sleep Improvement, and Alcohol Moderation. [2019]

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

Brief preoperative mind-body therapies for total joint arthroplasty patients: a randomized controlled trial. [2023]

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

Mindfulness Applications: Can They Serve as a Stress, Anxiety, and Burnout Reduction Tool in Orthopaedic Surgery Training? A Randomized Control Trial. [2023]