Clinical trial NCT05335421: Mindfulness and Hip Preservation Surgery
Official title: The Influence of Mindfulness on Patient-Reported Outcomes Following Hip Preservation Surgery
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hip Preservation Surgery
Keywords: mindfulness
outcomes
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, randomized controlled trial design
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in PROMIS Global Health Questionnaire (GHQ) Score
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: Change in PROMIS Anxiety and Depression Questionnaire Score
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: Change in International Hip Outcome Tool (IHOT) Score
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: Change in Modified Harris Hip Score (mHHS)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: Change in Single Assessment Numeric Evaluation (SANE) Score
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
measure: Change in Hip Outcome Score (HOS-ADL and HOS-SS)
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Total Duration of Mindfulness Training in the Mindfulness Group
timeFrame: up to 24 months
Other outcomes:
measure: Summary of Pain Locations
timeFrame: baseline, 3 months, 6 months, 12 months, 24 months
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Andrew Watson, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: