Trials / Active Not Recruiting
Active Not RecruitingNCT05335421
Mindfulness and Hip Preservation Surgery
The Influence of Mindfulness on Patient-Reported Outcomes Following Hip Preservation Surgery
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- University of Wisconsin, Madison · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Healthy 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. |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2026-04-01
- Completion
- 2026-04-01
- First posted
- 2022-04-19
- Last updated
- 2026-02-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05335421. Inclusion in this directory is not an endorsement.