NCT05634278

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2022

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

November 21, 2022

Last Update Submit

June 16, 2025

Conditions

PainAnxiety

Outcome Measures

Primary Outcomes (2)

  • Change in Preoperative Anxiety

    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.

    Immediately before to after the 7-minute preoperative intervention

  • Change in Postoperative, In-patient 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 the 7-minute postoperative intervention

Secondary Outcomes (4)

  • Change in Preoperative Pain Intensity

    Immediately before to after the 7-minute preoperative intervention

  • Change in Postoperative, In-patient Pain Intensity

    Immediately before to after the 7-minute postoperative intervention

  • Change in Preoperative Pain Unpleasantness

    Immediately before to after the 7-minute preoperative intervention

  • Change in Postoperative, In-patient Anxiety

    Immediately before to after the 7-minute postoperative intervention

Other Outcomes (4)

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

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

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

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

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

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

  • +1 more other outcomes

Study Arms (3)

Mind wandering

PLACEBO COMPARATOR
Behavioral: Mind wandering

Preoperative Mindfulness

ACTIVE COMPARATOR

Participants will only listen to the guided meditation practice before surgery.

Behavioral: Preoperative mindfulnessBehavioral: Mind wandering

Preoperative and Postoperative Mindfulness

ACTIVE COMPARATOR

Participant will listen to the guided meditation practice before surgery and during their hospital stay after surgery.

Behavioral: Preoperative mindfulnessBehavioral: Postoperative mindfulness

Interventions

Preoperative mindfulnessBEHAVIORAL

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

Preoperative MindfulnessPreoperative and Postoperative Mindfulness
Postoperative mindfulnessBEHAVIORAL

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

Preoperative and Postoperative Mindfulness
Mind wanderingBEHAVIORAL

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

Mind wanderingPreoperative Mindfulness

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 2, 2022

Study Start

November 14, 2022

Primary Completion

September 21, 2023

Study Completion

November 27, 2023

Last Updated

June 17, 2025

Record last verified: 2025-06

Locations

US(1)