Mindfulness Intervention in Orthopedic Trauma Patients

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Anxiety; Pain

Treatments: Behavioral: Postoperative mindfulness; Behavioral: Preoperative mindfulness; Behavioral: Mind wandering

Study type: Interventional

Funder types: Other

Identifiers

NCT05634278

IRB_00085446 AM_00046459

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 3 patient groups, including a placebo group

Mind wandering

Placebo Comparator group

Treatment:

Behavioral: Mind wandering

Preoperative Mindfulness

Active Comparator group

Description:

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

Treatment:

Behavioral: Mind wandering

Behavioral: Preoperative mindfulness

Preoperative and Postoperative Mindfulness

Active Comparator group

Description:

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

Treatment:

Behavioral: Preoperative mindfulness

Behavioral: Postoperative mindfulness