App Delivered Brief Mindfulness Intervention for Surgical Patients
1 other identifier
interventional
823
1 country
1
Brief Summary
This will be a single-site, five-arm, parallel group randomized control trial involving patients undergoing knee or hip replacement surgery. The investigators will compare five different styles of 5-minute, audio-recoded mindfulness practices delivered via app 7 days before to surgery, 2 days before to surgery, 2 days after surgery, and 6 days after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Jun 2022
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2022
CompletedStudy Start
First participant enrolled
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJune 17, 2025
June 1, 2025
2.9 years
June 21, 2022
June 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Pain Unpleasantness
Single item assessing pain unpleasantness ("How unpleasant is your pain?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Immediately before to after 5-minute audio recording
Secondary Outcomes (2)
Change in Pain Intensity
Immediately before to after 5-minute audio recording
Change in Pain Medication Desire
Immediately before to after 5-minute audio recording
Other Outcomes (3)
Change in Anxiety
Immediately before to after 5-minute audio recording
Change in Depression
Immediately before to after 5-minute audio recording
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
During the 6 weeks prior to surgery and at the 6-week outpatient follow-up appointment
Study Arms (5)
Breath Counting
ACTIVE COMPARATORBody Scan
EXPERIMENTALMindful Breathing
EXPERIMENTALMindfulness of Pain
EXPERIMENTALMindful Savoring
EXPERIMENTALInterventions
Patients will listen to a 5-minute, audio-recorded breath counting practice.
Patients will listen to a 5-minute, audio-recorded mindful breathing practice.
Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.
Patients will listen to a 5-minute, audio-recorded mindful savoring practice.
Eligibility Criteria
You may qualify if:
- Age ≥18,
- Scheduled to undergo total joint arthroplasty of the knee or hip
You may not qualify if:
- Inability to read English
- Cognitive impairment preventing completion of study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 27, 2022
Study Start
June 21, 2022
Primary Completion
May 26, 2025
Study Completion
November 1, 2025
Last Updated
June 17, 2025
Record last verified: 2025-06