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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01389 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (guided meditation) | Experimental | Patients listen to 10 minutes of guided meditation prior to surgery. |
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| Arm II (noise cancelling headphones) | Active Comparator | Patients wear noise cancelling headphones for 10 minutes prior to surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Listen to guided meditation |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre-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. | 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). | Pre and post intervention, approximately 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 6 months post intervention |
| Post-operative morphine equivalent dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The Ohio State University Comprehensive Cancer Center | Contact | 800-293-5066 | OSUCCCClinicaltrials@osumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Maryanna Klatt, PhD | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Behavioral Intervention | Behavioral | Wear noise cancelling headphones |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Survey Administration | Other | Ancillary studies |
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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. |
| 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. | Up to 6 months post intervention |
| Length of stay | Will be extracted from the electronic medical record via chart review. | Up to 6 months post intervention |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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