Brief Postoperative Pain Management Intervention: Meaning Making Amendment
1 other identifier
interventional
576
1 country
1
Brief Summary
This single-site, two-arm, parallel-group randomized controlled trial will enroll adults undergoing total knee or hip replacement surgery. Two days after surgery, participants will complete a brief guided mindful breathing practice delivered by text message and will then be randomized to receive either personalized meaning-making questions or implementation-focused questions. The trial will evaluate whether personalized meaning-making questions enhance the clinical effects of the mindfulness practice on acute pain, pain unpleasantness, anxiety, desire for pain medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
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 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
June 30, 2026
June 1, 2026
12 months
June 23, 2026
June 23, 2026
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 unpleasant, 10=The most unpleasant pain imaginable) numeric rating scale. Higher scores indicate greater pain unpleasantness.
Immediately before to after 5-minute audio recording
Secondary Outcomes (3)
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
Change in Anxiety
Immediately before to after 5-minute audio recording
Other Outcomes (1)
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointments
Study Arms (2)
Meaning Making Questions
EXPERIMENTALImplementation Questions
ACTIVE COMPARATORInterventions
Participants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer personalized meaning-making questions designed to help them reflect on what stood out during the practice and how that experience related to their pain, relaxation, or coping.
Participants randomized to this arm will receive a brief, text-message-delivered mindfulness intervention two days after total knee or hip replacement surgery. The intervention consists of a 5-minute guided mindful breathing practice that begins with visually paced breathing and then transitions to audio-guided mindful awareness of the breath. Immediately afterward, participants will answer two implementation-focused questions about how the intervention could best be delivered or used in postoperative care, such as preferred timing, length, or mode of delivery.
Eligibility Criteria
You may qualify if:
- Age ≥18,
- Underwent 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)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 30, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
June 30, 2026
Record last verified: 2026-06