Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery
- Conditions
- Hematopoietic and Lymphatic System NeoplasmMalignant Solid Neoplasm
- Registration Number
- NCT06949943
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Participants will be recruited among patients who are scheduled for cancer-directed surgery
- Participants must be 18 years or older
- Participants will be excluded from the study if they cannot speak English (as the meditation is recorded in English)
- Currently incarcerated
- Have a diagnosis of dementia
- Are admitted to the intensive care unit (ICU)
- Have a hearing impairment that would make them unable to hear the recorded meditation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pre-operative anxiety (PROMIS Anxiety scale) Pre and post intervention, approximately 10 minutes 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.
Pre-operative anxiety (single-item visual analog scale) Pre and post intervention, approximately 10 minutes 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).
- Secondary Outcome Measures
Name Time Method Post-operative opiate use Up to 6 months post intervention 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.
Post-operative morphine equivalent dose Up to 6 months post intervention 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.
Post-operative average daily morphine Up to 6 months post intervention 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.
Length of stay Up to 6 months post intervention Will be extracted from the electronic medical record via chart review.
Trial Locations
- Locations (1)
Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States