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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the Healthy Minds Program (HMP) App can aid recovery after hip surgery. The app may reduce anxiety and depression, which can impact healing and overall well-being. Participants will either use the app alongside standard care or receive only standard care to assess its effectiveness. Suitable candidates for this trial include individuals who have undergone hip preservation surgery, are between 18-45 years old, and have access to a compatible mobile device. As an unphased trial, this study allows participants to contribute to innovative research that could enhance recovery experiences for future patients.

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 prior data suggests that the Healthy Minds Program App is safe for hip surgery recovery?

Research has shown that the Healthy Minds Program (HMP) app is generally safe to use. In past studies, the app reduced stress, anxiety, and burnout without causing serious side effects. For example, using the app for just 5 minutes a day led to a 28% decrease in stress and an 18% decrease in anxiety. These results suggest the app is well-tolerated and may help improve mental well-being. While the studies show positive outcomes, researchers are still investigating its safety for people recovering from hip surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Minds Program (HMP) app because it brings mindfulness practices directly to patients recovering from hip surgery. Unlike the standard of care, which typically involves physical therapy and medication, this app offers a digital, self-guided approach to enhance mental well-being. The HMP app's unique features include its convenient delivery method, allowing users to engage in short, daily mindfulness exercises from their smartphones. This could potentially improve recovery outcomes by reducing stress and promoting a positive mindset, all while being easily accessible and non-invasive.

What evidence suggests that the Healthy Minds Program App is effective for hip surgery recovery?

Research has shown that mindfulness-based programs, such as the Healthy Minds Program (HMP) app, can reduce stress and anxiety. One study found that a mindfulness app significantly lowered stress and anxiety in orthopedic surgery residents within two months. Another review indicated that mindfulness practices helped reduce post-surgery pain, benefiting those recovering from hip surgery. Additionally, mindfulness has been linked to improved quality of life and reduced need for pain medication after surgery. In this trial, some participants will use the HMP app alongside standard care, potentially aiding hip surgery recovery by reducing stress and enhancing well-being. ^{1 3 4 6 7}

Who Is on the Research Team?

Andrew Watson, MD, MS

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-hip-preservation-surgery-9-2021-ee91f

Mindfulness App for Hip Surgery Recovery A mindfulness-based phone application significantly reduced stress, anxiety, and burnout in orthopaedic surgery residents after just 2 months of use, with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10328720/

Mindfulness-Based Interventions for the Reduction of ... The aim of this systematic review and meta-analysis is to evaluate the effect of mindfulness-based interventions (MBIs) on post-surgical pain in patients ...

3. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561912822000101

Improving Postoperative Care Through Mindfulness-Based ... Numerous other benefits, including improved quality of life and decreased postoperative opioid use, were also described from both interventions; however, ...

4. asset.library.wisc.edu asset.library.wisc.edu/1711.dl/VX2GTLQK3PGUT8Z/R/file-55ea4.pdf

The Influence of Mindfulness on Patient-Reported ... after surgery, as hip arthroscopy patients with comorbid mental health disorders incur greater ... Healthy Minds Program app (Android or iOS) and ...

5. mental.jmir.org mental.jmir.org/2020/11/e23825/

Three-Armed Randomized Controlled Trial - JMIR Mental Health This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7732708/

Testing the Efficacy of a Multicomponent, Self-Guided ... This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social ...

7. play.google.com play.google.com/store/apps/details?id=com.healthyminds&hl=en_US

Healthy Minds Program - Apps on Google Play Research with the Healthy Minds App showed that just 5 minutes a day of practice leads to a 28% reduction in stress, an 18% reduction in anxiety, a 24% ...