Mindfulness and Hip Preservation Surgery

NCT05335421 | Completed

• 3 other identifiers: 2021-0508Protocol Version 10/13/2021A536110
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Preservation Surgery

Keywords

mindfulness; outcomes

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Total Duration of Mindfulness Training in the Mindfulness Group

  up to 24 months

Other Outcomes (1)

• Summary of Pain Locations

  baseline, 3 months, 6 months, 12 months, 24 months

Study Arms (2)

Mindfulness Intervention plus Standard of Care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Control group receives standard of care only

Interventions

Healthy Minds Program (HMP) App BEHAVIORAL

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.

Mindfulness Intervention plus Standard of Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew Watson, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-blind, randomized controlled trial design

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: October 1, 2021
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)