Hip Preservation Surgery
Conditions
Keywords
mindfulness, outcomes
Brief summary
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
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
Interventions
BEHAVIORALHealthy Minds Program (HMP) App
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.
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Masking description
All healthcare providers involved in the care of the participant following surgery (surgeon, physician's assistants, nurses, medical assistants, etc.) will be blinded to the group assignment of each participant.
Intervention model description
single-blind, randomized controlled trial design
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PROMIS Global Health Questionnaire (GHQ) Score | baseline, 3 months, 6 months, 12 months, 24 months | 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. |
| Change in PROMIS Anxiety and Depression Questionnaire Score | baseline, 3 months, 6 months, 12 months, 24 months | Anxiety and depression will be assessed via an 8-item questionnaire scored from 0-5 where higher scores represents greater anxiety and depression. |
| Change in International Hip Outcome Tool (IHOT) Score | baseline, 3 months, 6 months, 12 months, 24 months | Hip-related QoL is assessed via a 12-item survey scored from 0-10 where higher scores represent better hip-related quality of life. |
| Change in Modified Harris Hip Score (mHHS) | baseline, 3 months, 6 months, 12 months, 24 months | 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. |
| Change in Single Assessment Numeric Evaluation (SANE) Score | baseline, 3 months, 6 months, 12 months, 24 months | Current illness is assessed via a single item survey scored from 0-100 where a higher score represents closer to uninjured baseline. |
| Change in Hip Outcome Score (HOS-ADL and HOS-SS) | baseline, 3 months, 6 months, 12 months, 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Duration of Mindfulness Training in the Mindfulness Group | up to 24 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndrew Watson, MD, MS
University of Wisconsin, Madison
Outcome results
None listed