This clinical trial tests how well guided meditation, compared to silence, works to reduce pre-operative anxiety in patients undergoing cancer-directed surgery. Pre-operative anxiety affects patient experience and has been found to be a predictor of severe post-operative pain and chronic pain after surgery, influencing the success and quality of a patient's recovery. While medication is often prescribed to improve anxiety symptoms, research has showed that mindfulness techniques can be used to decrease anxiety, improve comfort, and can impact both psychological and physiologic symptoms. Completing pre-operative guided meditation may work well to reduce pre-operative anxiety in patients undergoing cancer directive surgery.
PRIMARY OBJECTIVE: I. To improve is pre-operative patient anxiety in surgical settings. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients listen to 10 minutes of guided meditation prior to surgery. ARM II: Patients wear noise cancelling headphones for 10 minutes prior to surgery. After completion of study intervention, patients are followed up for up to 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
300
Listen to guided meditation
Wear noise cancelling headphones
Ancillary studies
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGPre-operative anxiety (PROMIS Anxiety scale)
Measured with the Patient Reported Outcome Measurement Information System Anxiety. PROMIS Anxiety short form is an 8-item scale used to assess anxiety in individuals 18 years or older. Each item is on a 5-point scale to be summed, with higher scores indicating greater anxiety.
Time frame: Pre and post intervention, approximately 10 minutes
Pre-operative anxiety (single-item visual analog scale)
Measured by a single-item visual analog scale. The single-item visual analog scale will be used to assess momentary anxiety. The item will ask, "On a scale of 1 to 10, how anxious do you feel right now?" and patients will rate the level of anxiety on a scale of 0 to 10 (0=not at all anxious, 10=extremely anxious).
Time frame: Pre and post intervention, approximately 10 minutes
Post-operative opiate use
Will be extracted from the electronic medical record via chart review. Days of opioid use will be calculated and compared between intervention and control groups.
Time frame: Up to 6 months post intervention
Post-operative morphine equivalent dose
Will be extracted from the electronic medical record via chart review. Daily morphine equivalent dose for each opioid prescribed will be calculated and compared between intervention and control groups.
Time frame: Up to 6 months post intervention
Post-operative average daily morphine
Will be extracted from the electronic medical record via chart review. Average daily morphine equivalent dose will be calculated and compared between intervention and control groups.
Time frame: Up to 6 months post intervention
Length of stay
Will be extracted from the electronic medical record via chart review.
Time frame: Up to 6 months post intervention
The Ohio State University Comprehensive Cancer Center
CONTACT
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