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NCT Number: NCT07676500

Brief Postoperative Pain Management Intervention: Meaning Making Amendment

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.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Acute Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18,
  • Underwent joint arthroplasty of the knee or hip

Exclusion criteria

  • Inability to read English
  • Cognitive impairment preventing completion of study procedures

Treatment and study plan

Mindfulness + Meaning Making Questions

Behavioral

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.

Mindfulness + Implementation Questions

Behavioral

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.

Primary outcomes

  1. Change in Pain Unpleasantness

    Time frame: Immediately before to after 5-minute audio recording

    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.

Secondary outcomes

  1. Change in Pain Intensity

    Time frame: Immediately before to after 5-minute audio recording

    Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=No pain, 10=Pain as bad as you can imagine) numeric rating scale. Higher scores indicate greater pain intensity.

  2. Change in Pain Medication Desire

    Time frame: Immediately before to after 5-minute audio recording

    Single item assessing pain unpleasantness ("How much do you want to take pain medicine?") scored on an 11-point (0=Not at all, 10=Extremely) numeric rating scale. Higher scores indicate greater desire for pain medicine.

  3. Change in Anxiety

    Time frame: Immediately before to after 5-minute audio recording

    Single item assessing pain unpleasantness ("How nervous, anxious, or on edge do you feel?") scored on an 11-point (0=Not at all, 10=Anxiety as bad as you can imagine) numeric rating scale. Higher scores indicate greater anxiety.

Other outcomes

  1. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0

    Time frame: During the 6 weeks prior to surgery and at the 2-, 6-, and 12-week outpatient follow-up appointments

    The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score reflects better physical functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Hanley

CONTACT

[email protected]

850-645-9557

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Brief Postoperative Pain Management Intervention for Knee and Hip Replacement Patients: Meaning Making Amendment

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 30, 2026
Registry last updated
Jun 30, 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.

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