Mindfulness and Hip Preservation Surgery

University of Wisconsin (UW)

Status: Invitation-only

Conditions: Hip Preservation Surgery

Treatments: Behavioral: Healthy Minds Program (HMP) App

Study type: Interventional

Funder types: Other

Identifiers

NCT05335421

Protocol Version 10/13/2021 (Other Identifier)

A536110 (Other Identifier)

2021-0508

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Mindfulness Intervention plus Standard of Care

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Minds Program (HMP) App

Standard of Care

No Intervention group

Description:

Control group receives standard of care only