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

NCT06949943 | Recruiting

• 2 other identifiers: OSU-24146NCI-2025-01389
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Post-operative opiate use

  Up to 6 months post intervention

• Post-operative morphine equivalent dose

  Up to 6 months post intervention

• Post-operative average daily morphine

  Up to 6 months post intervention

• Length of stay

  Up to 6 months post intervention

Study Arms (2)

Arm I (guided meditation)

EXPERIMENTAL

Patients listen to 10 minutes of guided meditation prior to surgery.

Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Survey Administration

Arm II (noise cancelling headphones)

ACTIVE COMPARATOR

Patients wear noise cancelling headphones for 10 minutes prior to surgery.

Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Survey Administration

Interventions

Behavioral Intervention BEHAVIORAL

Listen to guided meditation

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm I (guided meditation)

Electronic Health Record Review OTHER

Ancillary studies

Arm I (guided meditation); Arm II (noise cancelling headphones)

Survey Administration OTHER

Ancillary studies

Arm I (guided meditation); Arm II (noise cancelling headphones)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be recruited among patients who are scheduled for cancer-directed surgery
• Participants must be 18 years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Maryanna Klatt, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 29, 2025
• Study Start: March 14, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

US (1)