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Active, Not Recruiting

NCT Number: NCT05433389

App Delivered Brief Mindfulness Intervention for Surgical Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pain Anxiety Disorders Anxiety State Behavior Behavioral Symptoms Depression Depressive State Mental Disorders Neurologic Manifestations 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,
  • Scheduled to undergo total joint arthroplasty of the knee or hip

Exclusion criteria

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

Treatment and study plan

Breath Counting

Behavioral

Patients will listen to a 5-minute, audio-recorded breath counting practice.

Body Scan

Behavioral

Patients will listen to a 5-minute, audio-recorded body scan practice.

Mindful Breathing

Behavioral

Patients will listen to a 5-minute, audio-recorded mindful breathing practice.

Mindfulness of Pain

Behavioral

Patients will listen to a 5-minute, audio-recorded mindfulness of pain practice.

Mindful Savoring

Behavioral

Patients will listen to a 5-minute, audio-recorded mindful savoring practice.

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 at all, 10=Very much) 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=Not at all, 10=Very much) 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 pain medicine?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater desire for pain medicine.

Other outcomes

  1. 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=Very much) numeric rating scale. Higher scores indicate greater anxiety.

  2. Change in Depression

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

    Single item assessing pain unpleasantness ("How down, depressed, or uninterested in life do you feel?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater depression.

  3. 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 6-week outpatient follow-up appointment

    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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

App Delivered Brief Mindfulness Intervention for Knee or Hip Replacement Patients

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2022
Registry last updated
Jun 17, 2025

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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