Mindfulness Intervention in Orthopedic Trauma Patients

Pain Clinical Trial

Official title:

Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05634278
• Other study ID #: IRB_00085446 AM_00046459
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: Adam W Hanley
• Phone: 8012134191
• Email: adam.hanley[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Behavioral:
• Preoperative mindfulness
A seven-minute, audio-guided, mindfulness meditation practice.
• Postoperative mindfulness
A seven-minute, audio-guided, mindfulness meditation practice.
• Mind wandering
A timed, seven-minute mind wandering period during which participants are instructed: "For the next 7 minutes, allow your mind to wander."

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	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.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Other	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1	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.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Other	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0	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.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Other	Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0	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.	Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Primary	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
Primary	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	Change in Preoperative Pain Intensity	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.	Immediately before to after the 7-minute preoperative intervention
Secondary	Change in Postoperative, In-patient Pain Intensity	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.	Immediately before to after the 7-minute postoperative intervention
Secondary	Change in Preoperative 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 preoperative intervention
Secondary	Change in Postoperative, In-patient 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 postoperative intervention