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Completed

NCT Number: NCT05634278

Mindfulness Intervention in Orthopedic Trauma Patients

This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

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 at presentation between 18 and 65 years
  • Acute lower extremity fracture to be operatively managed
  • Glasgow Coma Scale of 15
  • English speaking
  • Willingness to participate in study

Exclusion criteria

  • Cognitive impairment
  • Pregnant or lactating woman
  • Current incarceration
  • Planned secondary procedure

Treatment and study plan

Preoperative mindfulness

Behavioral

A seven-minute, audio-guided, mindfulness meditation practice.

Postoperative mindfulness

Behavioral

A seven-minute, audio-guided, mindfulness meditation practice.

Mind Wandering

Behavioral

A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."

Primary outcomes

  1. Change in Preoperative Anxiety

    Time frame: Immediately before to after the 7-minute preoperative intervention

    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 Postoperative, In-patient Pain Unpleasantness

    Time frame: Immediately before to after the 7-minute postoperative intervention

    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 Preoperative Pain Intensity

    Time frame: Immediately before to after the 7-minute preoperative intervention

    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 Postoperative, In-patient Pain Intensity

    Time frame: Immediately before to after the 7-minute postoperative intervention

    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.

  3. Change in Preoperative Pain Unpleasantness

    Time frame: Immediately before to after the 7-minute preoperative intervention

    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.

  4. Change in Postoperative, In-patient Anxiety

    Time frame: Immediately before to after the 7-minute postoperative intervention

    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.

Other outcomes

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

    Time frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

    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. Higher scores reflect better physical functioning.

  2. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1

    Time frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

    The PROMIS pain interference computer assisted test draws from a bank of 40 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. Higher scores reflect greater pain interference.

  3. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0

    Time frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

    The PROMIS anxiety computer assisted test draws from a bank of 29 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. Higher scores reflect greater anxiety.

  4. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0

    Time frame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively

    The PROMIS depression computer assisted test draws from a bank of 28 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. Higher scores reflect greater depression.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 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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