Completed

NCT Number: NCT05335421

Mindfulness and 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.

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Key information

Conditions

Hip Preservation Surgery

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Change in PROMIS Global Health Questionnaire (GHQ) Score

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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 outcomes

Total Duration of Mindfulness Training in the Mindfulness Group

Time frame: 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.

Other outcomes

Summary of Pain Locations

Time frame: baseline, 3 months, 6 months, 12 months, 24 months

Pain location will be assessed by asking the participant to identify current location of pain.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Apr 19, 2022
Registry last updated: Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.