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Enhancing Quality of Patient Experience Via an Innovative Reduction of Pre-Operative Anxiety

NCT ID: NCT06949943Sponsor: Ohio State University Comprehensive Cancer CenterLast updated: 2026-05-07

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.

Arms & interventions

  • BehavioralBehavioral Intervention

    Listen to guided meditation

  • BehavioralBehavioral Intervention

    Wear noise cancelling headphones

  • OtherElectronic Health Record Review

    Ancillary studies

  • OtherSurvey Administration

    Ancillary studies

Outcome measures

Primary

  • 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.

    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

Secondary

  • Post-operative opiate use

    Time frame: Up to 6 months post intervention

  • Post-operative morphine equivalent dose

    Time frame: Up to 6 months post intervention

  • Post-operative average daily morphine

    Time frame: Up to 6 months post intervention

  • Length of stay

    Time frame: Up to 6 months post intervention

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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

Study locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Maryanna Klatt, PhD · Contact
Maryanna Klatt, PhD · Principal Investigator
Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery | Cancerify