Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
Interventions
BEHAVIORALBehavioral Intervention
Listen to guided meditation
OTHERElectronic Health Record Review
Ancillary studies
OTHERSurvey Administration
Ancillary studies
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants will be recruited among patients who are scheduled for cancer-directed surgery * Participants must be 18 years or older
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORMaryanna Klatt, PhD
Ohio State University Comprehensive Cancer Center
Outcome results
None listed