Mindfulness and Hip Preservation Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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The goal is to identify whether a mobile-based daily mindfulness program for the immediate eight weeks following hip preservation surgery improves outcomes in patients. The investigators hypothesize that patients who participate in a mindfulness intervention will have less pain, better hip function, greater quality of life, and improved scores on standardized patient reported outcome measures for 24 months following surgery. The investigators expect their findings will re-direct post-operative strategies beyond the physical recovery in orthopedic surgery patients and improve long-term outcomes. To test the overall hypothesis and contribute significantly to understanding of the impact of a psychosocial intervention on outcomes in orthopedic surgery patients, the specific aim is to determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery. Specific Aim 1: To determine the influence of mindfulness training on patient-reported outcomes following hip preservation surgery Hypothesis 1: Mindfulness training will be associated with improvements in pain, post-operative opiate use, hip function, quality of life and improved scores on standardized patient reported outcome measures for 24 months following hip preservation surgery Specific Aim 2: To determine the factors that influence mindfulness efficacy in patient-reported outcomes following hip preservation surgery Hypothesis 2: Among participants in the mindfulness group, total duration of mindfulness training, female gender, and higher education level will be independently and positively associated with improvements in pain, hip function, and quality of life for 24 months following hip preservation surgery

Official Title
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The Influence of Mindfulness on Patient-Reported Outcomes Following Hip Preservation Surgery

Conditions
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Hip Preservation Surgery

Intervention / Treatment
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* Behavioral: Healthy Minds Program (HMP) App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-45 years old at the time of the pre-operative visit Access to a mobile device compatible with the freely available Healthy Minds Program (HMP) App (Android or iOS) Participation in study 2019-0363 Exclusion Criteria: Prior diagnosis of serious mental illness (schizophrenia, bipolar disorder, schizoaffective disorder, etc). Significant prior experience with meditation or mindfulness, defined as greater than 30 minutes in a month during the past year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-blind, randomized controlled trial design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Intervention plus Standard of Care<br>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. | Behavioral: Healthy Minds Program (HMP) App<br>* The full HMP app includes 5 modules with practices designed to cultivate categories of mental and emotional skills linked to both hedonic and eudaimonic well-being. These include the cultivation of mindful attention (Awareness), positive relationships with self and others (Connection), insight into the nature of self and internal experience (Insight), and purpose, values, and meaning in life (Purpose), as well as an initial module which includes abbreviated introductions to the topics and lessons in all four areas (Foundations). For this study, the active intervention will include 4 weeks of training using the Foundations module followed by 4 weeks of training using the Awareness module.<br>|
| No Intervention: Standard of Care<br>Control group receives standard of care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Global Health Questionnaire (GHQ) Score | Global quality of life (QoL) will be assessed via a 9-item questionnaire scored on a 0-100 scale where higher scores indicate better QoL, pain interference, and fatigue. | baseline, 3 months, 6 months, 12 months, 24 months | 
| Change in PROMIS Anxiety and Depression Questionnaire Score | Anxiety and depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety and depression. | baseline, 3 months, 6 months, 12 months, 24 months | 
| Change in International Hip Outcome Tool (IHOT) Score | Hip-related QoL is assessed via a 12-item survey scored from 0-10 where higher scores represent better hip-related quality of life. | baseline, 3 months, 6 months, 12 months, 24 months | 
| Change in Modified Harris Hip Score (mHHS) | Hip function is assessed via an 8-item survey scored on various scales with a total possible range of scores from 0-91 where higher scores indicate better hip pain and function. | baseline, 3 months, 6 months, 12 months, 24 months | 
| Change in Single Assessment Numeric Evaluation (SANE) Score | Current illness is assessed via a single item survey scored from 0-100 where a higher score represents closer to uninjured baseline. | baseline, 3 months, 6 months, 12 months, 24 months | 
| Change in Hip Outcome Score (HOS-ADL and HOS-SS) | Function with Activities of Daily Living and Sport Specific activities are assessed via a 28-items scored from 0-4 where higher scores indicate improved function. | baseline, 3 months, 6 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Duration of Mindfulness Training in the Mindfulness Group | The hypothesis is that among participants in the mindfulness group, total duration of mindfulness training, female gender, and higher education level will be independently and positively associated with improvements in pain, hip function, and quality of life for 24 months following hip preservation surgery. | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, outcomes