Mindfulness and Hip Preservation Surgery

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hip Preservation Surgery
• Intervention / Treatment: Behavioral: Healthy Minds Program (HMP) App

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Intervention plus Standard of Care; 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; 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.
No Intervention: Standard of Care; Control group receives standard of care only

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Pain Locations	Pain location will be assessed by asking the participant to identify current location of pain.	baseline, 3 months, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Andrew Watson, MD, MS, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; outcomes
• Other Study ID Numbers: 2021-0508; A536110 (Other Identifier: UW Madison); Protocol Version 10/13/2021 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No