Pre-Operative Guided Meditation to Reduce Pre-Operative Anxiety in Patients Undergoing Cancer-Directed Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Maryanna Klatt, PhD; Phone Number: 614-366-1056; Email: Maryanna.Klatt@Osumc.edu
      • Principal Investigator: Maryanna Klatt, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (guided meditation); Patients listen to 10 minutes of guided meditation prior to surgery.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Behavioral Intervention; Listen to guided meditation; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Wear noise cancelling headphones; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Active Comparator: Arm II (noise cancelling headphones); Patients wear noise cancelling headphones for 10 minutes prior to surgery.	Other: Survey Administration; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Behavioral: Behavioral Intervention; Listen to guided meditation; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Wear noise cancelling headphones; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Maryanna Klatt, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: March 25, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: OSU-24146; NCI-2025-01389 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No